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Back to jobs Director, Regulatory Affairs - Clinical Remote - US Apply About Loyal Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress toward our first regulatory approvals, with additional submissions targeted in the near future. Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love. About the role We’re seeking an experienced Director Regulatory Affairs, Clinical to serve as Loyal’s subject matter expert on FDA Center for Veterinary Medicine (CVM) regulatory strategy and clinical trial operations. This is a high-impact, hands-on role for someone who thrives on owning complex regulatory programs end-to-end — from INAD strategy through pivotal submission — and who brings deep expertise in FDA CVM clinical development. You will be the primary interface between Loyal and FDA CVM for clinical regulatory matters, owning our regulatory submissions, and helping shape the strategies that bring our longevity drugs to market. You will also manage 1–2 direct reports as the team grows. Your work will directly shape the regulatory path to bring novel longevity therapeutics through FDA CVM approval for the first time in any species, setting regulatory precedent for an entirely new category of medications. This role is for someone who has at least 10+ years of regulatory affairs experience. The ideal candidate should be a strategic thinker that is comfortable owning complex, first-of-kind regulatory programs with limited precedent, possess deep working knowledge of FDA CVM clinical development pathways and submission requirements and thrive in an environment operating with a great deal of autonomy in setting direction, making judgement calls, and driving programs and regulatory pathways forward in an agile organization. You will be reporting to our VP of Regulatory Affairs . Your daily work will include Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence Leading preparation for FDA CVM meetings, including briefing documents, meeting requests, posing questions, and follow-up MOCs Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations About you Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree 10+ years of regulatory affairs experience with with 3+ years in animal health, direct experience with owning FDA/CVM relationships. Hands on ownership experience with INADs, regulatory submissions, and FDA CVM in-person meetings Background across multiple drug types ideal (small molecules, biologics, injectables, etc.) You are data-driven and an analytical thinker; your regulatory experience is grounded in evidence and you communicate with excellence Strong and experienced writer that takes pride in clarity, accuracy and persuasive story telling about biological pathways or drug mechanisms and clinical impacts Extensive knowledge of FDA CVM regulatory pathways, policies, and limitations and where there are areas to innovate within those bounds Excellent judgement where FDA CVM is concerned and comfortable being the single source of strategic conviction using that judgement Collaborative with cross-functional teams and not afraid to be in the weeds while also being the subject matter expert Ability to operate as a high level individual contributor while also serving as a mentor to junior team members in order to upskill the department. Energized by a fast-paced startup environment Salary Range: $155,000 - $205,000 Loyal benefits Full-coverage health insurance — medical, dental and vision — for you and your dependents $1,000 home office equipment stipend $1,200/year learning budget for books, courses, etc. $250/month wellness budget for gym, cleaners, spa, food, etc. All 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. Our values Moonshots, derisked methodically Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure. Opportunity is at the intersection We lean into combining disciplines, expertise, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat. High agency, high humility Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generate clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission. Lead with transparency and context We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions. Empathy and respect for all life Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously. Apply for this job * indicates a required field Autofill my application First Name* Last Name* Email* Phone Country* Phone* Location (City)* Locate me Resume/CV* Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Do you now or in the future require sponsorship for employment?* Select... LinkedIn Profile Website Submit application Powered by

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

Biotech/Pharma

142 days ago

Vice President, Quality Assurance

Olema Oncology · San Francisco, California

Pay

$315k–340k

Setting

On-site

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Vice President, Quality Assurance 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 >>> Vice President, Quality Assurance  The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development. This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed. As Vice President, Quality Assurance, your work will primarily encompass: Quality Strategy & Leadership  Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   Foster a culture of quality, integrity, and patient focus across the organization   Act as escalation point for significant quality, compliance, and patient safety risks   Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains  Quality Systems & Governance  Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   Establish clear quality metrics and reporting to enable risk visibility and informed decision-making  Clinical Quality (GCP)  Ensure Quality approaches appropriately support the execution of oncology clinical trials   Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   Partner with Clinical and Regulatory to support inspection-ready programs and submissions Manufacturing & Commercial Readiness (GMP)  Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   Provide Quality input into CMC, validation, and supply chain readiness activities Pharmacovigilance Quality (GPV)  Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   Ensure PV systems and vendors are appropriately governed and inspection-ready   Partner cross-functionally to support ongoing evaluation of benefit-risk Inspection, Audit & Risk Management  Lead the Company’s approach to regulatory inspections, including preparation and execution   Ensure risk-based audit programs across GCP, GMP, and GPV   Drive proactive identification and mitigation of quality and compliance risks Cross-Functional Leadership  Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   Provide clear, actionable Quality perspectives to support business decisions   Represent Quality in executive discussions and external engagements as needed   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 Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement Expertise across GCP, GMP, and GPV Quality domains Strong understanding of Quality systems, governance, and inspection readiness practices Working knowledge of oncology drug development Experience Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility Significant people management and leadership experience, including leading senior team members Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors Demonstrated experience across GCP, GMP, and GPV environments Proven track record supporting programs from clinical development through late-stage or commercial readiness Experience leading regulatory inspections and interacting with global health authorities Experience implementing and maintaining Quality systems and compliance frameworks Attributes Strong leadership capability with ability to lead through and develop senior leaders Effective communicator with executive presence and influencing skills Sound judgment and decision-making in complex, risk-based environments Ability to operate effectively in a fast-paced, evolving biotech environment Commitment to quality, compliance, and patient safety The base pay range for this position is expected to be $315,000 - $340,000 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... 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

142 days ago

Vice President Quality Assurance

Olema Oncology · Boston, Massachusetts

Pay

$315k–340k

Setting

On-site

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Vice President Quality Assurance 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 >>> Vice President, Quality Assurance  The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development. This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed. As Vice President, Quality Assurance, your work will primarily encompass: Quality Strategy & Leadership  Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   Foster a culture of quality, integrity, and patient focus across the organization   Act as escalation point for significant quality, compliance, and patient safety risks   Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains  Quality Systems & Governance  Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   Establish clear quality metrics and reporting to enable risk visibility and informed decision-making  Clinical Quality (GCP)  Ensure Quality approaches appropriately support the execution of oncology clinical trials   Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   Partner with Clinical and Regulatory to support inspection-ready programs and submissions Manufacturing & Commercial Readiness (GMP)  Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   Provide Quality input into CMC, validation, and supply chain readiness activities Pharmacovigilance Quality (GPV)  Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   Ensure PV systems and vendors are appropriately governed and inspection-ready   Partner cross-functionally to support ongoing evaluation of benefit-risk Inspection, Audit & Risk Management  Lead the Company’s approach to regulatory inspections, including preparation and execution   Ensure risk-based audit programs across GCP, GMP, and GPV   Drive proactive identification and mitigation of quality and compliance risks Cross-Functional Leadership  Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   Provide clear, actionable Quality perspectives to support business decisions   Represent Quality in executive discussions and external engagements as needed   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 Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement Expertise across GCP, GMP, and GPV Quality domains Strong understanding of Quality systems, governance, and inspection readiness practices Working knowledge of oncology drug development Experience Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility Significant people management and leadership experience, including leading senior team members Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors Demonstrated experience across GCP, GMP, and GPV environments Proven track record supporting programs from clinical development through late-stage or commercial readiness Experience leading regulatory inspections and interacting with global health authorities Experience implementing and maintaining Quality systems and compliance frameworks Attributes Strong leadership capability with ability to lead through and develop senior leaders Effective communicator with executive presence and influencing skills Sound judgment and decision-making in complex, risk-based environments Ability to operate effectively in a fast-paced, evolving biotech environment Commitment to quality, compliance, and patient safety The base pay range for this position is expected to be $315,000 - $340,000 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... 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

148 days ago

Director/Senior Director, Medicinal Chemistry

Iambic Therapeutics · San Diego, California, United States

Pay

$196k–280k

Setting

On-site

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JOB SUMMARY We seek an accomplished and creative medicinal chemistry leader with a proven track record of success in advancing drug discovery programs, setting scientific strategy, and leading cross-functional teams to deliver impact. Candidates should be motivated to work in an intensely collaborative, multidisciplinary, team-based setting. The role will entail leading drug discovery projects, coordinating a medicinal chemistry team with internal and external experimental capabilities, as well as proactively interfacing with diverse teams working on automated experimentation, ML-driven molecular generation, property predictions, and bioassay data generation. This position will be on-site at our San Diego Headquarters. KEY RESPONSIBILITIES - Lead a group of project scientists and drive molecular discovery efforts to deliver development and clinical candidates - Devise strategies to execute hit ID, identify lead molecules and optimize them for potency, selectivity, and ADME properties using multivariant SAR analysis and hypothesis driven design principles. - Act as a liaison between Iambic, CROs, and other external collaborators, including partnered research projects - Influence the prospective use of computational methods and leverage automated synthesis and high-throughput experimentation capabilities - Work closely with AI/ML teams to develop and implement relevant predictive models to aid in the design of new molecules - Contribute to platform development by collaborating with AI/ML and chemistry automation teams to enhance processes and accelerate the design–make–test (DMT) cycle. - Communicate project updates clearly and effectively to the broader team and key stakeholders - Work as a senior member of the Chemistry research group and foster a culture of scientific excellence, innovation, and teamwork QUALIFICATIONS - Ph.D. in Organic Chemistry with 15+ years of Pharma/bio-tech drug discovery experience (portfolio of programs from hit/lead to development candidate) or MS/BS with 20+ years of experience - Expertise in modern synthetic organic chemistry, evidenced by high-quality publications and patents. - Proven cross-functional leadership: integrating biology, DMPK/ADME, CADD, and CMC to build and execute strategic project plans. - Practical experience and working knowledge of target protein degradation and associated modalities (molecular glues, PROTACS) - Track record of program leadership advancing compounds through preclinical development (candidate nomination, IND-enabling interfaces, CRO oversight). - Experience working with computational chemists as part of project team in design of drug targets is required - Strong interpersonal, communication, time management, and leadership skills - Experience mentoring or leading junior chemists - Creative problem solving and management of relationships with several stakeholders within and beyond the company ABOUT IAMBIC THERAPEUTICS Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai http://iambic.ai. MISSION & CORE VALUES Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies. PAY AND BENEFITS We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.

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

Biotech/Pharma

162 days ago

Senior Clinical Trial Associate

Olema Oncology · Boston, Massachusetts

Pay

$110k–120k

Setting

On-site

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Senior Clinical Trial Associate 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 >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines. This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel. Your work will primarily encompass: Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities Conducts oversight of sample collection, shipment, and analyses Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead Identifies potential risks and proactively resolves issues with CROs Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s) Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms. Coordinates electronic distribution and/or shipment of study-related materials, as appropriate Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF) Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes 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 Bachelor’s degree is required Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred Working knowledge of clinical protocols Experience Minimum of 3 years of related industry experience is required Senior CTA requires 2 years' experience working as a Clinical Trial Associate. Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook) Experience with leading small group meetings and/or managing vendor relationships Attributes Highly motivated and enjoys working in a fast-paced, dynamic environment Excellent teamwork and collaboration skills Good organizational skills, ability to manage multiple tasks and meticulous attention to detail Excellent written and verbal communication skills Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed The base pay range for this position is expected to be $110,000 - $115,000 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... 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

162 days ago

Senior Clinical Trial Associate

Olema Oncology · San Francisco, California

Pay

$100k–115k

Setting

On-site

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Senior Clinical Trial Associate 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 >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide comprehensive administrative and operational support to clinical team members across all study activities, including both in-house and outsourced trials. This role supports cross-functional study execution through coordination with internal teams, external vendors, and site staff, and may include contributing to study documentation such as informed consent forms (ICFs) and central IRB submissions, supporting site payments and other study-related operational activities, as well as liaising with and following up with investigator sites. Responsibilities include assisting with study start-up, maintenance, and closeout activities; managing study documentation and materials; supporting vendor management; and maintaining study trackers and financial records. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice (ICH) guidelines. This role is based out of either our office San Francisco or Cambridge office and will require approximately 10% travel. Your work will primarily encompass: Supports the Clinical Trial Lead (CTL) and Study Execution Team (SET), ensuring ongoing accurate and essential documentation of study conduct Manages study-related vendors and serves as a point of contact for contracted CROs, study staff, contract labs, and other study vendors Acts as a key point of contact for investigator sites, facilitating communication, and ensuring effective coordination of study-related activities Conducts oversight of sample collection, shipment, and analyses Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead Identifies potential risks and proactively resolves issues with CROs Assists in the development of vendor management and other study plans and compiles study and quality metrics for CTL, management, and/or team review(s) Facilitates flow and maintenance of correspondence with vendors and sites to provide or obtain study-specific information Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents Assists in coordination of study initiation documentation materials, including support for central IRB submission documents and review of site-specific informed consent forms. Coordinates electronic distribution and/or shipment of study-related materials, as appropriate Collaborates with relevant team members in the coordination and tracking of vendor and investigator site contracts, budgets, invoices, and/or payments as needed Contributes to the development of the TMF plan and conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF) Performs study and departmental administrative and clerical duties such as preparing agendas and minutes for team meetings and providing meeting planning and presentations Actively participates in department initiatives and goals, providing suggestions that support the vision, mission, and enhancement of Clinical Operations; may lead certain SOPs or other processes 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 Bachelor’s degree is required Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred Working knowledge of clinical protocols Experience Minimum of 3 years of related industry experience is required Senior CTA requires 2 years' experience working as a Clinical Trial Associate Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook) Experience with leading small group meetings and/or managing vendor relationships Attributes Highly motivated and enjoys working in a fast-paced, dynamic environment Excellent teamwork and collaboration skills Good organizational skills, ability to manage multiple tasks and meticulous attention to detail Excellent written and verbal communication skills Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed The base pay range for this position is expected to be $100,000 - $115,000 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... Submit application Powered by

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