Your Role:

• You will be the lead and an integral part of Relay’s drug product development team supporting development programs.
• You will be responsible for design, development and optimization of patient-centric (e.g. pediatric) drug product formulation and clinical / commercially viable manufacturing process including selection appropriate packaging (container closure systems) for Relay’s pipeline products.
• You will be leading and managing the outsourcing (formulation / product development and manufacturing) activities at global CRO/CMO sites, in alignment with program goals.
• You will manage prototype development/feasibility assessment and clinical manufacturing activities.
• You will support current and/or plan formulation / drug product R&D and GMP stability studies in collaboration with internal AD/QC, QA teams and third parties.
• You will be a key drug product SME for successful execution of the technology transfer of drug product processes to manufacturing site(s), providing technical in-puts / insights to the Relay’s CMOs.
• You will draft, review and approve specifications, batch records and other critical development and GMP documents.
• You will author, review and ensure completion of drug product sections of CMC-regulatory submission documents (IND, IMPD, NDA, PIP, iPSP, briefing packages etc.), responses to regulatory questions and providing supporting documentation, in a timely manner.
• You will be an asset and key member of Relay’s cross-functional teams and work collaboratively to meet the program/project objectives and key results (OKRs).
• You will evaluate and implement new and sustainable drug product technologies for Relay’s pipeline products and life-cycle management, as applicable.

Your Background/Qualifications:

• Advanced degree (doctoral or post-doctoral degree in Pharmaceutics, Pharmaceutical Sciences or related fields) and minimum of 8-10 years of relevant industry experience with proven track-record in oral solids (granules, minitablets, sprinkles/powders for reconstitution, capsules), liquid suspension formulations, manufacturing process development and optimization / scale-up thereof.
• Understanding of basics / fundamentals of pediatric product development with focus on selection of excipients, dosage form and packaging configuration for pediatric population.
• Experience with palatability assessment, taste masking and in-use stability/food-compatibility is desirable.
• Excellent understanding of the phase-appropriate IR oral formulations and manufacturing process development along with overall pharmaceutical product development process is a requisite.
• Experience and knowledge in identifying critical process parameters (CPPs), design space, design of experiments (DoE) and handling statistical programs commonly used in pharmaceutical industry.
• Knowledge of current Good Manufacturing Practices (cGMP) and experience in pharmaceutical development of new chemical entities under cGMP.
• Knowledge of CMC quality guidelines (particularly US, EU, JP and ICH guidelines) relevant to oral solid drug product development.
• Ability to author, review technical reports to support IND/NDA submission, regulatory compliance, and IP requirements.
• Exceptional organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Demonstrated strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, leadership, planning, and collaboration skills
• Exceptional attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties

Estimated Salary Range: [$143,000 - $203,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#BP1

The Opportunity:

As the Senior Associate/Associate Director of Portfolio and Strategy Operations, you will help ensure flawless operation of activities for a first-in-class program as it moves through clinical development while reporting to the Director of Portfolio Strategy and Operations. You will enable collaboration and alignment across key cross-functional team members such as Medical, Clinical Operations, and Pharmaceutical Development and with stakeholders in leadership.

Your Role:

• Are you flexible and fearless in the face of rapidly evolving opportunity and ambiguity? You will effectively contribute both operationally and strategically on a program moving through early clinical development.
• Do you see problems as opportunities? You will be expected to bring structure to complex and ambiguous problems, synthesize findings, develop creative / innovative options, and make logically supported recommendations. This could include helping define a molecular diagnostics strategy or monitoring drug supply/patient demand dynamics.
• Develop and maintain program timelines to ensure that all efforts are coordinated, and to identify key interdependencies, risks, and critical path activities.
• You thrive operating in a matrixed role and seamlessly facilitate cross functional discussions to drive towards shared goals and program progression.
• You will help to update and refine processes to support the team achieving key deliverables. You will also help steer content for leadership and external KOL meetings.
• You are someone who has the communication chops to build narratives, craft visuals, refine messaging and tell compelling stories as we communicate progress back to the Executive Leadership Team and Board.
• You are critical to the management and maintenance of the project long-range strategic plan, in close collaboration with your project team colleagues.

Your Background:

• You have experience (minimum 3 years) in management consulting, operations, program management and executive communication
• You have a science or management consulting background
• You are an open and candid communicator and know how to leverage your strong EQ, organizational savviness, and collaborative nature to lead and develop alignment across teams and organizations

Estimated Salary Range: [$120,000 - $200,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#JO1

Reporting to: Sr. Director, Clinical Data Management

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.

X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

This opportunity will …

Provide strategic and operational leadership for clinical data management activities across one or more clinical development programs. The Associate Director will oversee CRO partners and vendors, drive data quality and inspection readiness, support regulatory submissions, and ensure the timely delivery of high-quality clinical trial data.

This role will serve as a key cross-functional leader, partnering with Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, Pharmacovigilance, Regulatory Affairs, and external vendors to deliver study objectives while maintaining compliance with regulatory requirements and industry standards.

Accountabilities and Responsibilities:

Clinical Data Management Leadership

Vendor and CRO Oversight

Data Quality and Inspection Readiness

Cross-Functional Collaboration

Process Improvement

Requirements: Proven Experience, Skills, and Education:

Strong understanding of:

About this opportunity:

At Freenome, we are seeking a Senior Development Scientist I to help grow the Freenome Genomics Late Development team. You will develop, optimize, verify, and validate clinical-grade assay technologies for Freenome's multiomic platform, advancing our mission to detect cancer earlier. Working across manual and automated workflows, you will collaborate with cross-functional teams to develop and transfer robust NGS-based assays into a regulated, high-throughput production environment. You are passionate about developing life saving diagnostics using NGS technologies, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Senior Manager of Genomics Development. This role will be an onsite role based in our Brisbane, California headquarters.

What you’ll do:

• Apply knowledge of molecular biology, nucleic-acid biochemistry, and next-generation sequencing to develop assays for DNA, including genome-wide and targeted approaches.
  
• Oversee and lead mission-critical experiments to optimize, characterize, verify, and validate NGS-based assays, owning scientific strategy, experimental design, planning, timelines, execution, and delivery.
  
• Design and execute high-impact experiments, generate detailed documentation, perform data analysis, create summary presentations, and present results cross-functionally.
  
• Troubleshoot complex technical challenges, identify root causes, and drive process improvements to assay performance and laboratory workflows.
  
• Drive project planning and prioritization by defining milestones, identifying and mitigating risks, and adapting to evolving program needs.
  
• Build productive working relationships and partner cross-functionally with computational scientists, engineers, and clinical laboratory team members to transition development protocols into clinical production, including automation, validation experiments, and SOP development.
  
• Document product development requirements and author study protocols and reports. Diligently apply current Good Laboratory and Documentation Practices (cGLP, cGDP) to maintain high standard of scientific rigor and quality.
  

Must haves:

• PhD in molecular biology, biochemistry, genetics, or a related field with at least 4 years of professional experience in the life sciences, or a Bachelors or Masters degree with at least 10 years of professional experience. Prior experience in clinical diagnostics and/or working in a start-up environment is preferred.
  
• Experience designing and leading the execution of verification and validation studies for IVD assays in a regulated clinical laboratory environment (GLP).
  
• Extensive hands-on experience in Next-gen sequencing (NGS) based automated assay development including extraction, library preparation, target capture, and sequencing. Experience working with automated platforms and liquid handlers.
  
• Extensive hands-on experience in nucleic acid preparation, amplification, and quantification (DNA/RNA extraction and purification, PCR, qPCR, Qubit, Fragment Analyzer, Tapestation). Experience in working with ctDNA/cfDNA as an analyte in NGS workflows.
  
• Proven track record of designing, planning, and executing successful experiments, including performing independent data analysis and giving effective scientific presentations.
  
• High attention to detail and ability to record accurate and detailed observations, assess impact, and lead independent troubleshooting investigations.
  
• Excellent written and verbal communication. Proactive communicator with ability to foster collaboration in a multidisciplinary team.
  
• Flexible and highly motivated to learn new skills and comfortable adapting to changing priorities.
  
• Experience providing technical mentorship and training to other scientists and research associates to contribute to a culture of technical excellence and continuous improvement.
  

Nice to haves:

• Experience in working with with methylated ctDNA/cfDNA as an analyte in NGS workflows.
• Familiarity with scientific programming or data analysis tools such as Python or R, and experience contributing to publications, patents, or other scientific innovations.
  

Benefits and additional information:

The US target range of our base salary rate for new hires is (Insert range here, low of Tier 3 and high of Tier 1). You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

California applicants please review the CCPA Notice at Collection here:

• California Consumer Privacy Act (CCPA)

#LI-ONSITE

The Opportunity:

As Manager, Clinical Science at Relay Tx, you will play a key role in driving the development of our assets and support the implementation and execution of the clinical strategy. You will work closely with clinical project management, regulatory affairs, clinical operations, biostatistics, data management, and medical writing to advance one or more clinical studies. You will have the opportunity to make an impact through providing your strategic and scientific input to cross functional teams.

Your Role:

• Contribute to the design of clinical studies in close collaboration with the Medical Lead as well as Clinical Development team.

• Lead and/or contribute to protocol development with medical writing by translating the approved protocol concept into executable/efficient clinical protocols

• Drive the medical contribution together with Medical Leads to annual update of IB, DSUR liaising with cross functional teams

• Support Medical Leads to answer regulatory queries and contribute to other submissions related to studies

• Perform medical data review and analysis of study results; and review protocol deviations to identify cause and appropriate resolution.

• Contribute to the design of electronic case report forms, ensuring that eCRFs accurately capture the data intended to be gathered per protocol.

• Support data cleaning activities requiring medical interpretation and analyses of data for regulatory submissions, data disclosure and scientific publications

• Support Medical Lead to monitor real time study data to ensure the integrity of the study and the study data and working closely with clinical operations team to answer protocol related questions and resolve any study conduct issues from investigative sites

• Review and summarize relevant literature for competitive intelligence, and author and review manuscripts, abstracts, posters, etc.

• Managing communication and building strong collaborative relationships with key stakeholders both internally and externally, including interactions with academic experts, clinical trial investigators, and other clinical stakeholders.

Your Background:

• Advanced degree in life sciences: PhD and/or MS, PharmD, BSN in relevant scientific field; with 2 years of experience in pharmaceutical and/or biotech industry.

• Knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required

• Thorough understanding of ICH, GCP, and relevant regulatory requirements is required

• Experience in early/ late phase development and oncology preferred

• Strong interpersonal, organization, planning and communication and writing skills.

• Ability to prioritize and manage multiple tasks simultaneously, being a team player, being flexible and have hands-on attitude.

• Ability to influence with collaboration, and drive decision-making within multi-disciplinary teams

#JO1

About this opportunity:

At Freenome, we are seeking a Senior Research Associate to help grow the Freenome Genomic Early Development team. As a Senior Research Associate, you will participate in the development of genomic assay technologies and contribute to Freenome’s multiomic product portfolio aimed at early cancer detection. You will work closely with Scientists, Automation Engineers, and Computational Biologists to develop, optimize, and characterize efficient automated workflows to improve experimental and clinical throughput in a regulated high throughput environment. You will also work with Operations, Quality, and Regulatory to transfer complex methodologies, processes, and assays to Operations to ensure the highest quality data is produced by our clinical lab. You are passionate about contributing to developing life-saving diagnostics through early cancer detection, and you will have a significant impact on the continued growth of an organization dedicated to changing the entire landscape of cancer.

The role reports to the Senior Manager of Genomic Early Development team. This role will be an Onsite role based in our Brisbane, California headquarters.

What you’ll do:

• Apply hands-on knowledge of molecular biology, nucleic-acid biochemistry and next generation sequencing to develop and optimize NGS based methods and processes following principles of Design Controls for IVD development.
  
• Design and perform experiments to develop, optimize, and characterize NGS workflow including DNA/RNA extraction, library preparation, target capture, and sequencing.
  
• Operate and maintain NGS related instruments such as automated liquid handlers, PCR instruments, and sequencers.
  
• Conduct new reagents testing and develop reagent quality control methods.
  
• Participate in troubleshooting issues, identify and implement process improvement for the entire analytical workflow.
  
• Collaborate with research, computational scientists, and automation engineers to transfer research prototype assays from Research to Development.
• Collaborate with Quality Control Lab, Manufacturing lab, Quality, and Regulatory to transfer reagent quality control methods and manufacturing processes from Development to Operations and support the implementation of the methods and processes in Operations.
• Accurately record results in electronic lab notebooks, author work instructions and record forms, contribute to writing study protocols and reports. Diligently apply current Good Laboratory and Documentation Practices (cGLP, cGDP).
  

Must haves:

• Bachelor’s in molecular biology, biochemistry, or a related field with at least 4 years of experience in the life sciences or Master’s in molecular biology or a related field.
  
• Hands-on experience in Next-gen sequencing (NGS) based assay development including extraction, library preparation, target capture, and sequencing.
  
• Familiarity with molecular biology, genomics, NGS, assay development, sample preparation, reagent handling, or related laboratory workflows (e.g. plasma separation processes, DNA/RNA extraction, purification, and quantification, NGS library preparation).
  
• Experience designing, planning, and executing successful experiments, interpreting results, preparing data for review, and giving effective scientific presentations.
  
• High attention to detail and ability to record accurate and detailed observations, assess impact, and perform troubleshooting as required.
  
• Ability to manually pipette with high confidence, accuracy, and precision.
  
• Clear and proactive communication skills and ability to collaborate effectively with team members in the same and adjacent disciplines.
  
• Strong organizational skills and the ability to contribute the design and implementation of new processes.
  
• Flexible and highly motivated to learn new skills and comfortable adapting to changing priorities.
  

Nice to haves:

• Experience in working with with methylated ctDNA/cfDNA as an analyte in liquid biopsy workflows.
  
• Experience with automated liquid handlers, laboratory information systems, sample tracking systems, and equipment scheduling/status tools.
  
• Familiarity with programing in a scientific programming language (e.g., Python or R).
  

Benefits and additional information:

The US target range of our base salary rate for new hires is $97,850 - $126,000. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

California applicants please review the CCPA Notice at Collection here:

• California Consumer Privacy Act (CCPA)

#LI-ONSITE

Position Summary:

The Content Analyst (Data Steward) is a skilled and detail-oriented individual responsible for ensuring the accuracy, completeness, and consistency of data throughout our Products. You engage in analyzing and evaluating content across various Products to ensure accuracy, relevance, and quality. This role reports directly to the Product Owner in Precision Medicine Group, India. You work closely with various teams to ensure that data is properly classified, managed, and updated.

Essential functions of the job include but are not limited to:

• Monitoring and maintaining data quality by validating, cleansing, and enriching data as needed
• Work with stakeholders to identify critical data elements and define data quality standards.
• Create and maintain data dictionaries, data lineage, and metadata management practices.
• Develop and maintain data governance policies, procedures, and standards.
• Monitor and maintain the integrity of data across multiple systems and applications.
• Conduct data profiling and analysis to identify data quality issues and recommend solutions.
• Develop and maintain data management tools, including data quality dashboards, scorecards, and reports.
• Work with Operations teams to ensure that data management processes are integrated into adjacent development and delivery activities.
• Train end-users on data management best practices and procedures.
• Ensure compliance with data privacy, security, and regulatory requirements.
• Participate in data governance committees and collaborate with other data stewards to develop and implement enterprise-wide data management strategies.
• Gather feedback from internal users and external clients to understand their needs and translate them into meaningful data product improvements.

Minimum Required:

• Bachelor's degree in computer science, information management, or a related field.
• At least 1-3 years of experience in data management, data governance, or a related field.
• Strong understanding of data management concepts, including data quality, metadata management, data lineage, and data governance.
• Familiarity with SQL, data modeling, and database management systems.

Other Required:

• Experience with data profiling and analysis tools.
• A combined of 1-2 years of work experience across US Healthcare data.
• Knowledge of data privacy, security, and regulatory compliance requirements.

Preferred:

• Experience with Reltio, Informatica or other MDM tools
• Familiarity with Snowflake