Jobs - Jobs4Americans

Back to jobs Neurosurgical Robot Operator South San Francisco, California, United States Apply About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. Team Description: The Neurosurgical Robot Operator Team, a division of the Surgery & Robot Hardware Department, is directly responsible for the setup and operation of surgical robots during surgeries under medical professional supervision. Our team regularly collaborates on cross-functional projects to enhance robotic surgical capabilities. Job Description and Responsibilities: As a Neurosurgical Robot Operator, you will be in charge of conducting tests for engineering teams and communicating with cross-functional experts to build efficiencies around robot operation during surgery. Furthermore, you will be responsible for training surgeons, clinicians, and engineers to operate the robot for surgery and testing. Other job duties will entail: Setting up and operating surgical robots during surgeries and testing Utilizing GLP documentation Developing Standard Operating Procedures (SOPs) and work Instructions for robot operation and validation Communicating effectively while troubleshooting technical issues alongside robotics and surgical experts Managing inventory of parts, fixtures, tooling, spare parts, and consumables Applying 5S principles (Sort, Set in order, Shine, Standardize, Sustain) to maintain a clean and organized workspace environment Performing additional projects or duties as assigned Required Qualifications: Minimum of 2 years of troubleshooting/testing experience, or equivalent Strong technical aptitude and problem-solving skills Excellent verbal and written communication abilities Meticulous attention to detail Commitment to safety Preferred Qualifications: Bachelor of Science (BS) degree or equivalent industry experience Prior experience in robotics operation, maintenance, or related fields Research or (pre)clinical experience in a medical or scientific setting Solid understanding of engineering first principles Expected Compensation: At Neuralink, your base pay is one part of your total compensation package. The anticipated hourly rate for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. California Hourly Range: $24.52 — $40.87/Hr USD What We Offer: Full-time employees are eligible for the following benefits listed below. An opportunity to change the world and work with some of the smartest and most talented experts from different fields Growth potential; we rapidly advance team members who have an outsized impact Excellent medical, dental, and vision insurance through a PPO plan Paid holidays Commuter benefits Meals provided Equity (RSUs) *Temporary Employees & Interns excluded 401(k) plan *Interns initially excluded until they work 1,000 hours Parental leave *Temporary Employees & Interns excluded Flexible time off *Temporary Employees & Interns excluded Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Please provide three examples of accomplishments that highlight your exceptional ability. Provide quantitative details and metrics to describe your impact. First example:* Second example:* Third example:* Are you currently authorized to work in the United States?* Select... Will you, at any point, require employer sponsorship to work in the United States?* Select... Which onsite location would you like to apply to? Select... I am willing and able to work entirely on-site.* Select... I will need relocation to work on-site.* Select... Ideal start date in office* How did you hear about us?* Select... Please specify LinkedIn Profile Additional Link Include a link to any additional content (e.g. personal website, Github, portfolio, etc.) Preferred Pronouns Submit application Powered by

Listed by Neuralink for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

65 days ago

Product Manager, Growth, Scientific AI Models

Benchling · San Francisco, California, United States

Pay

$163k–221k

Setting

On-site

Apply Sign in to favorite Permalink

We are rebuilding biotech for the AI era. When a breakthrough is delayed, the world waits. Getting a molecule from discovery to patients, or a crop from lab to field, involves thousands of slow, manual, disconnected steps. AI has the potential to change this, compressing decades of R&D work into years. But that only happens when clean, structured scientific data and AI are built into how science gets done. Benchling is the AI platform for biotech R&D. Scientists use Benchling to design experiments, capture structured data, and run AI agents and models directly in their workflows. Over 200,000 scientists around the world trust Benchling to power their most important work, from academic labs to Sanofi, Moderna, and more than half of the world's top 50 biopharma. We’re building an AI scientist for our customers. We can’t do that if we haven’t built the muscle ourselves. AI fluency is the foundation we build on; it's core to how we work, and we're committed to helping every new hire integrate it into their day-to-day. As part of our interview process, you'll complete a brief AI-focused exercise or discussion so we can understand how you think about and use AI to drive impact in your role. Feel free to reference any tools, platforms, or workflows you use today. ROLE OVERVIEW The Model Hub team is building a computational platform that provides access to cutting-edge scientific AI models to help scientists design better drugs. Scientific models (e.g. AlphaFold or Boltz2) predict structures, predict scientific properties, and generate new drug designs, acting as a design partner and a major time saver to scientists who are creating life-saving therapeutics. As the growth-focused product manager on the team, you'll own the product execution of our scientific AI models products and features, including Model Hub, and drive how customers adopt and grow their usage of these models. You'll split your time between talking with customers to understand their needs and gather feedback, and managing product definition and execution to bring the products they want to life. This is a highly cross-functional role: you'll partner closely with engineering, legal, strategy, and sales/GTM to get cutting-edge scientific AI into the hands of the scientists who need it. It's early days for scientific AI models, both at Benchling and in the industry at large. We'll rapidly iterate with customers and change directions quickly, figuring out new patterns for how we develop and go to market. We'll win if we stay curious and obsess over our customers. RESPONSIBILITIES - Own the product roadmap for our scientific model platform — defining and prioritizing the models, features, and capabilities that let scientists run inference fast, reliably, and cost-effectively across a diverse set of scientific models. - Define intuitive and beautiful product experiences across UI and API that let computational users execute high-throughput runs and analyze their results, translating customer needs into clear requirements for engineering. - Work directly with customers to ideate use cases, gather feedback, and grow adoption and usage of our scientific AI models across scientific teams. - Help shape how we build AI at Benchling — driving experimentation, contributing to product and technical direction, and helping evolve our product development and go-to-market practices as the field matures. QUALIFICATIONS - 5+ years of product management experience building technical or platform products, ideally in scientific, ML/AI, or other data-intensive domains. - Technical fluency: you can read API specs, reason about system tradeoffs, and have credible conversations with engineers about how scientific models are built and served. - Strong analytical skills, comfortable using data to drive product decisions and to measure and grow adoption and usage. - Collaborative mindset, able to work closely with engineers, scientists, and partners across legal, strategy, and GTM to bring new ideas to life. - Desire to work in a fast-paced environment, where priorities can shift and rapid experimentation is encouraged. HOW WE WORK This is an in-person team in San Francisco built around collaborating in the office in a fast-paced environment. We’re in the office Monday through Friday. #EN-1 Benchling welcomes everyone. We believe diversity enriches our team so we hire people with a wide range of identities, backgrounds, and experiences. We are an equal opportunity employer. That means we don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We also consider for employment qualified applicants with arrest and conviction records, consistent with applicable federal, state and local law, including but not limited to the San Francisco Fair Chance Ordinance.

Listed by Benchling for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

65 days ago

Don't see the right role?

Hyfé Foods · San Francisco, CA

Pay

Not listed

Setting

On-site

Apply Sign in to favorite Permalink

Hyfé Subscribe View jobs Back to all jobs Don't see the right role? Part-time or Full-time San Francisco, CA We’ll be hiring individual contributor, management, and executive roles in the next few months. Don’t see an open role that matches your background, but you’re passionate about Hyfé? We’d still love to hear from you. Tell us a bit about yourself—we’re always looking for exceptional people! San Francisco, CA - In-person, full time About Hyfe: See our coverage from the World Economic Forum here. Every year, approximately one billion tons of nutrient-rich fruit and vegetable waste is discarded or under-utilized across global food systems. For processors, getting rid of this waste is costly and emissions-intensive, creating significant environmental impact with little to no economic return. Yet these waste streams contain valuable compounds that could transform the economics of businesses across the food system and help catalyze the production of sustainable chemicals and materials. Hyfé exists to change that. Hyfé transforms food waste into high-value ingredients using a label-friendly, thermochemical refining process. Our products range from bioactives to fibers, and are being commercialized to make the food we eat healthier for people and the planet. Our team of scientists and engineers brings decades of expertise from the oil refining and chemical industries, specializing in scaling industrial processes and pioneering sustainable solutions. At Hyfé, you’ll have the opportunity to build at the earliest stages of a mission-driven company—working alongside a world-class team, shaping real products, and helping define how the next generation of ingredients are made. Our mission is simple: To transform carbon we waste into carbon we need. Posted on July 8, 2026 Tell a friend Share on LinkedIn Share on X Apply now Apply here Name(required) Email address(required) Phone number(required) Location(required) LinkedIn profile https://linkedin.com/in/ Website URL https:// Resume(required) Attach resume/CV What unique skills, experience, or perspective would you bring to Hyfé? How do you think you could contribute to our mission, and why should we consider you for this role?(required) What level best describes your current experience?(required) Select all that apply Select... Which area best matches your background and interests?(required) Select all that apply Select... In one sentence, what type of role or opportunity would you be most interested in exploring at Hyfé?(required) What excites you about joining a seed-stage company, and what do you know about Hyfé?(required) Are you able to work in-person in San Francisco 5 days per week?(required) select Submit application This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Powered by Polymer Polymer is the leading hiring platform and applicant tracking system for growing businesses.

Listed by Hyfé Foods for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

70 days ago

Implementation Manager

Benchling · San Francisco, California, United States

Pay

$93k–126k

Setting

Hybrid

Apply Sign in to favorite Permalink

We are rebuilding biotech for the AI era. When a breakthrough is delayed, the world waits. Getting a molecule from discovery to patients, or a crop from lab to field, involves thousands of slow, manual, disconnected steps. AI has the potential to change this, compressing decades of R&D work into years. But that only happens when clean, structured scientific data and AI are built into how science gets done. Benchling is the AI platform for biotech R&D. Scientists use Benchling to design experiments, capture structured data, and run AI agents and models directly in their workflows. Over 200,000 scientists around the world trust Benchling to power their most important work, from academic labs to Sanofi, Moderna, and more than half of the world's top 50 biopharma. We’re building an AI scientist for our customers. We can’t do that if we haven’t built the muscle ourselves. AI fluency is the foundation we build on; it's core to how we work, and we're committed to helping every new hire integrate it into their day-to-day. As part of our interview process, you'll complete a brief AI-focused exercise or discussion so we can understand how you think about and use AI to drive impact in your role. Feel free to reference any tools, platforms, or workflows you use today. ROLE OVERVIEW Benchling is building a world-class Professional Services team to drive implementations for our rapidly expanding customer base. Implementation Managers work with our customers, from small Biotech startups to the largest BioPharmas in the world to develop a deep understanding of their R&D Processes, and roll out solutions that transform how their research teams work together. To be successful in this role, you will leverage your scientific background, project management skills, and product expertise to drive successful implementations of the Benchling platform. You will work hand in hand with the research scientists at our customers, and teams throughout Benchling to implement our solutions, and ensure our customers are successful. Implementation Managers lead all aspects of customer rollouts from requirements analysis and solution design, to configurations, testing, training, and onboarding users onto the system. RESPONSIBILITIES - Manage initial rollouts for new Benchling customers as well as expansion projects with new teams or for new processes at existing customers. - Own implementation success from project kickoff to go-live, leveraging strong project management skills, scientific expertise, and deep product knowledge. - Build and execute detailed project plans, own project activities, work with other team members to execute on project deliverables to ensure on time, on budget, high quality deployments. - Understand customers' scientific workflows and determine how Benchling can best be leveraged to meet their key business needs. - Lead requirements and design workshops, perform data modeling & application configuration, develop test plans and guide UAT execution, train and onboard users. - Act as a trusted advisor for customers, guiding them through the implementation ensuring they leverage and apply Benchling Best Practices. - Understand and document customer pain points, advocate for them internally to influence product changes. - Develop and optimize enterprise training programs including written and video collateral. - Identify and work with sales on opportunities for account expansion post go-live. QUALIFICATIONS Requirements - Degree in Molecular Biology, Biochemistry, Biotechnology, Immunology, Bioinformatics, Biological Engineering or a related field. Advanced degrees preferred. - At least 2 years of experience in a lab or research setting. You must be able to empathize with scientists and quickly understand complicated scientific concepts. - Strong communication skills. You must be able to quickly and effectively connect with a range of stakeholders, including scientists, IT project leads, and executives. - Self-starter with the ability to be successful in a startup environment. - Curious, creative, and tenacious. You should be excited to collaborate with customers and other Benchling teammates as a thought partner. - Ability to travel up to 25% based on customer and project needs. Bonus if you have: - Experience using Benchling, especially if you’ve been a Benchling administrator. - Software Implementation experience, preferably with a SaaS software company. HOW WE WORK We offer a flexible hybrid work arrangement that prioritizes in-office collaboration. Employees are expected to be on-site 3 days per week (Monday, Tuesday, and Thursday). #LI-Hybrid #BI-Hybrid Benchling welcomes everyone. We believe diversity enriches our team so we hire people with a wide range of identities, backgrounds, and experiences. We are an equal opportunity employer. That means we don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We also consider for employment qualified applicants with arrest and conviction records, consistent with applicable federal, state and local law, including but not limited to the San Francisco Fair Chance Ordinance.

Listed by Benchling for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

70 days ago

Specialist, Production Project Support

Orca Bio · Sacramento, CA

Pay

$70k–95k

Setting

On-site

Apply Sign in to favorite Permalink

Specialist, Production Project Support Sacramento, CAManufacturing – Production /Regular, Full-Time Employee /On-Site APPLY FOR THIS JOB More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Specialist, Production Project Support supports the execution and documentation of business process improvements, change controls, CAPA initiatives, and the development and maintenance of Standard Operating Procedures (SOPs). This role works cross-functionally with production, quality assurance, engineering, and continuous improvement teams to ensure timely and compliant execution of changes and improvement projects within a regulated manufacturing environment Essential Duties & Key Responsibilities Assist in the identification, documentation, and implementation of business process improvements to enhance efficiency, quality, and cost-effectiveness. Coordinate data collection and analysis to support root cause investigations and improvement initiatives. Support the preparation, tracking, and execution of change control documentation in compliance with quality and regulatory standards. Ensure all impacted stakeholders are involved in the review and approval of changes. Maintain accurate records of change implementation and outcomes. Support the execution and documentation of corrective and preventive actions, including follow-up activities. Assist in CAPA investigations by compiling data, organizing cross-functional meetings, and tracking completion of action items. Ensure CAPA documentation meets internal and regulatory expectations. Draft, revise, and maintain SOPs in collaboration with subject matter experts. Ensure SOPs reflect current best practices and regulatory requirements. Facilitate training rollout and ensure personnel are informed of updated procedures. Track progress of ongoing production-related projects and report on milestones, issues, and risks. Schedule and facilitate cross-functional meetings as needed to support project deliverables. Maintain accurate and organized project documentation. Minimum Qualifications Bachelor’s degree in Life Sciences, Engineering, or related field. 2+ years of experience in a GMP-regulated biotech or pharmaceutical environment. Project management knowledge is a plus. Technical writing skills a plus. Strong understanding of cell therapy, biotech or pharmaceutical manufacturing processes Proven track record of successfully implementing improvement projects Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products is preferred. Excellent communication, leadership, and organizational skills. PMP Certification or equivalent formal project management training is preferred Familiarity with Lean Six Sigma or operational excellence methodologies is a plus Travel Requirements and Work Environment Domestic and international travel not required. On-site presence required, especially during critical project phases or production support. May involve gowning and working in classified cleanroom environments, including no jewelry, makeup, etc. Occasional off-hours or weekend work depending on project needs. $70,000 - $95,000 a year The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. APPLY FOR THIS JOB Orca Bio Home Page Jobs powered by

Listed by Orca Bio for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

70 days ago

Director, Safety Sciences

Olema Oncology · Boston, Massachusetts

Pay

$235k

Setting

On-site

Apply Sign in to favorite Permalink

Director, Safety Sciences Boston, Massachusetts Apply Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It’s an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon. Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day. If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond. About the Role >>> Director, Safety Sciences As the Director, Safety Sciences reporting to the Senior Director, Safety Science you will provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle, supporting global regulatory submissions and ongoing product development. Oversee the development of key safety deliverables for NDA/BLA filings, lead integrated benefit-risk assessments, and drive cross-functional alignment on safety strategy and regulatory interactions. Ensure compliance with FDA, EMA, ICH, and other global regulatory requirements while enabling proactive risk management and informed benefit-risk decision-making. This role is based out of our San Francisco or Boston office and will require less than 10% travel Your work will primarily encompass: Lead the preparation of safety components for NDA/BLA submissions, ensuring alignment with FDA, EMA, and ICH requirements. Author and review integrated safety documents, including the Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), benefit-risk assessments, and clinical overviews. Collaborate and support in the development of safety narratives, datasets, analyses, and submission-ready safety deliverables for regulatory filings. Conduct comprehensive evaluation and integration of safety data from clinical studies to support overall benefit-risk assessment for marketing applications. Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming teams to develop safety strategies and analyses supporting regulatory submissions. Prepare and review safety sections of key regulatory documents, including NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, and Company Core Data Sheets (CCDS). Lead development and maintenance of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other risk management documents as applicable. Participate in preparation and overall regulatory agency meetings (FDA, EMA, PMDA, MHRA, etc.), including safety briefing materials and responses to health authority questions. Partner with QA in regulatory inspections and audits, ensuring submission-related safety documentation is inspection ready. Review and interpret safety findings from clinical trials, literature, and post-marketing data to support regulatory decision-making and labeling recommendations. Contribute to the development of product labeling, including safety sections of prescribing information, package inserts, and related risk communication materials. Oversee aggregate safety reporting activities, including DSURs, PBRERs/PSURs, PADERs, and other periodic safety reports required during product development and registration. Provide strategic safety input for submission timelines, filing readiness assessments, and regulatory risk mitigation plans. Ensure compliance with applicable FDA, EU, ICH, and global pharmacovigilance regulations governing clinical safety and marketing authorization applications. Lead cross-functional safety review meetings and communicate safety findings effectively to internal stakeholders, regulatory authorities, and external partners. Ideal Candidate Profile >>> A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge: MD, PhD in the field of medical/biological science, PharmD, or RN degree Small Molecule and Oncology is a must Experience: Minimum of 8+ (MD, PhD, PharmD) or 10+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry Late phase clinical development and registration experience; NDA/BLA submissions and submission readiness planning Experience with clinical safety data integration and ISS authoring/review Proven experience with benefit-risk assessments and regulatory justification Experience with labeling negotiations and safety labeling strategy Demonstrated success leading health authority meeting preparation and regulatory responses Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities, along with regulatory response management Familiar with the clinical database/EDC, CTD/eCTD knowledge Ability to work with the safety database for purposes of clinical/medical case review and simple queries Experience working with business partners and managing safety vendors Track record of leading, managing, mentoring and teaching new/junior team members Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents Attributes: Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines Strong verbal and written skills to convey safety findings and recommendations with clarity Excellent analytical, problem-solving, strategic planning, and interpersonal skills Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization Demonstrates sound judgment, professionalism, and strong ethical standards The base pay range for this position is expected to be $235,000-$255,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview. Apply for this job * indicates a required field First Name* Last Name* Preferred First Name Email* Phone Country* Phone* Location (City)* Locate me Resume/CV Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Home Address* City* State* Zip Code* LinkedIn Profile* Website Are you legally authorized to work in the United States?* Select... Do you now or will you in the future require employer sponsorship?* Select... Do you reside within a within a 50 mile radius of San Francisco CA or Cambridge MA?* Select... Are you a MD, PhD, PharmD, or RN?* Select... Do you have direct pharmacovigilance/drug safety experience supporting small molecule oncology products?* Select... Have you led late stage clinical development submission activities, including submission readiness planning?* Select... Submit application Powered by

Listed by Olema Oncology for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

70 days ago

Director, Safety Sciences

Olema Oncology · San Francisco, California

Pay

$235k–255k

Setting

On-site

Apply Sign in to favorite Permalink

Director, Safety Sciences San Francisco, California Apply Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It’s an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon. Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day. If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond. About the Role >>> Director, Safety Sciences As the Director, Safety Sciences reporting to the Senior Director, Safety Science you will provide leadership for the strategy, evaluation, and communication of clinical safety data across the development lifecycle, supporting global regulatory submissions and ongoing product development. Oversee the development of key safety deliverables for NDA/BLA filings, lead integrated benefit-risk assessments, and drive cross-functional alignment on safety strategy and regulatory interactions. Ensure compliance with FDA, EMA, ICH, and other global regulatory requirements while enabling proactive risk management and informed benefit-risk decision-making. This role is based out of our San Francisco or Boston office and will require less than 10% travel. Your work will primarily encompass: Lead the preparation of safety components for NDA/BLA submissions, ensuring alignment with FDA, EMA, and ICH requirements. Author and review integrated safety documents, including the Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), benefit-risk assessments, and clinical overviews. Collaborate and support in the development of safety narratives, datasets, analyses, and submission-ready safety deliverables for regulatory filings. Conduct comprehensive evaluation and integration of safety data from clinical studies to support overall benefit-risk assessment for marketing applications. Collaborate with Clinical Development, Biostatistics, Regulatory Affairs, Medical Writing, and Programming teams to develop safety strategies and analyses supporting regulatory submissions. Prepare and review safety sections of key regulatory documents, including NDA/BLA modules, Investigator Brochures, protocols, informed consent forms, briefing books, and Company Core Data Sheets (CCDS). Lead development and maintenance of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and other risk management documents as applicable. Participate in preparation and overall regulatory agency meetings (FDA, EMA, PMDA, MHRA, etc.), including safety briefing materials and responses to health authority questions. Partner with QA in regulatory inspections and audits, ensuring submission-related safety documentation is inspection ready. Review and interpret safety findings from clinical trials, literature, and post-marketing data to support regulatory decision-making and labeling recommendations. Contribute to the development of product labeling, including safety sections of prescribing information, package inserts, and related risk communication materials. Oversee aggregate safety reporting activities, including DSURs, PBRERs/PSURs, PADERs, and other periodic safety reports required during product development and registration. Provide strategic safety input for submission timelines, filing readiness assessments, and regulatory risk mitigation plans. Ensure compliance with applicable FDA, EU, ICH, and global pharmacovigilance regulations governing clinical safety and marketing authorization applications. Lead cross-functional safety review meetings and communicate safety findings effectively to internal stakeholders, regulatory authorities, and external partners. Ideal Candidate Profile >>> A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge: MD, PhD in the field of medical/biological science, PharmD, or RN degree Small Molecule and Oncology is a must Experience: Minimum of 8+ (MD, PhD, PharmD) or 10+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry Late phase clinical development and registration experience; NDA/BLA submissions and submission readiness planning Experience with clinical safety data integration and ISS authoring/review Proven experience with benefit-risk assessments and regulatory justification Experience with labeling negotiations and safety labeling strategy Demonstrated success leading health authority meeting preparation and regulatory responses Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities, along with regulatory response management Familiar with the clinical database/EDC, CTD/eCTD knowledge Ability to work with the safety database for purposes of clinical/medical case review and simple queries Experience working with business partners and managing safety vendors Track record of leading, managing, mentoring and teaching new/junior team members Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents Attributes: Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines Strong verbal and written skills to convey safety findings and recommendations with clarity Excellent analytical, problem-solving, strategic planning, and interpersonal skills Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization Demonstrates sound judgment, professionalism, and strong ethical standards The base pay range for this position is expected to be $235,000 - $255,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview. Apply for this job * indicates a required field First Name* Last Name* Preferred First Name Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Home Address* City* State* Zip Code* LinkedIn Profile* Website Are you legally authorized to work in the United States?* Select... Do you now or will you in the future require employer sponsorship?* Select... Do you reside within a within a 50 mile radius of San Francisco CA or Cambridge MA?* Select... Are you a MD, PhD, PharmD, or RN?* Select... Do you have direct pharmacovigilance/drug safety experience supporting small molecule oncology products?* Select... Have you led late stage clinical development submission activities, including submission readiness planning?* Select... Submit application Powered by

Listed by Olema Oncology for a position based in the United States. Employers on this board attest they are hiring domestically.

Biotech/Pharma

70 days ago

Senior Medical Science Liaison (Southeast Region)

Olema Oncology · Remote

Pay

Not listed

Setting

Remote

Apply Sign in to favorite Permalink

Senior Medical Science Liaison (Southeast Region) Remote Apply Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It’s an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon. Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day. If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond. About the Role >>> Senior Medical Science Liaison, Southeast Region As the Senior Medical Science Liaison reporting to the Director, Medical Science Liaison, you will serve as a scientific expert and external representative for Olema. You will engage with key opinion leaders and healthcare providers to facilitate scientific exchange, communicate medical and clinical information, and support Olema's medical affairs objectives. This is a field-based role (Southeast Region) that requires 50% travel. Your work will primarily encompass: Identify, connect, cultivate and maintain relationships with key opinion leaders, healthcare professionals and researchers in both academic and community centers within the assigned territory Develop and execute territory engagement plans that aligned with medical affairs strategies to optimize impact in the field Provide medical and scientific insights to internal stakeholders to inform product development and strategy Facilitate and support new and ongoing clinical research in collaboration with medical and clinical operations teams (company-sponsored trials, investigator-initiated studies, and other collaborative initiatives) Serve as a trusted scientific and medical resource, providing accurate and updated information about Olema therapies and research externally Conduct medical education programs and presentations to healthcare professionals as needed to relay information about Olema’s products and research And will also include: Maintain up-to-date knowledge of developments in breast cancer research, treatment options, and disease management Professionally represent Olema at select medical and scientific conferences and meetings Serve as scientific resource to commercial partners, as appropriate, to support activities Ideal Candidate Profile >>> A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge: Doctorate degree (MD, PharmD or PhD) Oncology therapeutic expertise required Strong analytical skills demonstrating the ability to identify and understand complex issues/problems Strong communication and presentation skills required Experience: Minimum of 5 years of medical affairs or field medical experience with a verifiable record of high performance Prior experience in solid tumors required with breast cancer experience strongly preferred Clinical trial development and drug launch experience strongly preferred Field medical experience within the Southeast region strongly preferred Attributes: Simplifying complex information into clear, concise messages to effectively communicate the company story Excellent communication skills – written, verbal, presentation, interpersonal Serving in a high-visibility role and making public presentations to a variety of audiences Ability to work in cross-functional teams with internal stakeholders Anticipating needs, meeting tight deadlines, being proactive, and exercising independent decision-making Managing the communication of sensitive and confidential information This is a role where judgement, tact, flexibility and resourcefulness are key Strong relationship-building and negotiating skills Highly organized with an attention to detail and ability to meet timelines in a fast-paced environment Strong project management skills; can work on multiple projects simultaneously and effectively prioritize workload The base pay range for this position is expected to be $185,000 - $200,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview. Apply for this job * indicates a required field First Name* Last Name* Preferred First Name Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Home Address* City* State* Zip Code* LinkedIn Profile* Website Are you legally authorized to work in the United States?* Select... Do you now or will you in the future require employer sponsorship?* Select... Please confirm which state in the Southeast you currently reside in* Select... Please confirm which doctorate degree you hold.* Select... Do you have at least 5 years of Medical Affairs and/or Field Medical (MSL) experience?* Select... Do you have direct Medical Affairs or Field Medical experience supporting solid tumor oncology products or clinical programs?* Select... Submit application Powered by

Listed by Olema Oncology for a position based in the United States. Employers on this board attest they are hiring domestically.

Select a role

The full posting opens here — pay, setting and the full description, without leaving the list.