Septerna
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
For more information see: www.septerna.com.
Pick a job to read the details
Tap any role on the left — its description and apply link will open here.
Director/Senior Director, Regulatory Affairs
Share this job
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
About the Role
Septerna is seeking an experienced and highly motivated Director/Senior Director of Regulatory Affairs to lead regulatory strategy and execution across our discovery and development programs. This individual will be responsible for developing and implementing regulatory plans and submissions to support preclinical and clinical development, IND/CTA submissions, and interactions with global health authorities. The ideal candidate will bring deep regulatory expertise, strong cross-functional leadership, and a proactive, strategic mindset suited to a fast-paced biotech environment. This position reports into the VP, Regulatory Affairs.
Responsibilities
- Develop and implement regulatory strategies for clinical stage programs, ensuring alignment with business and development objectives.
- Serve as the primary Regulatory Affairs representative on project teams, providing guidance on regulatory requirements and pathways.
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, CTAs, amendments, briefing packages, and responses to health authority inquiries.
- Manage interactions with FDA and other global regulatory agencies; coordinate and prepare for regulatory meetings.
- Partner with CMC, Nonclinical, and Clinical teams to ensure compliance with applicable regulations and consistent messaging across submissions.
- Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies.
- Monitor the evolving regulatory landscape and communicate implications for Septerna’s programs.
- Support the development of internal regulatory processes, systems, and documentation to enable scalability as the organization grows.
- Mentor and develop junior regulatory staff and contribute to a culture of collaboration and excellence.
Qualifications
- Bachelor’s degree in life sciences or a related field; advanced degree (PhD, PharmD, or MS) preferred.
- Prior experience as a Global Regulatory Lead (GRL) preferred.
- 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry, including direct experience leading IND and/or CTA submissions.
- Proven track record of successful interactions with the FDA and other global regulatory agencies.
- Strong understanding of drug development processes, from discovery through clinical stages.
- Excellent project management, organizational, and verbal and written communication skills.
- High attention to detail and accuracy.
- Ability to thrive in a dynamic, fast-paced environment and work effectively across functions.
- Hands-on, strategic thinker with a collaborative and solution-oriented mindset.
Ready to apply?
Apply to Septerna
Director, Clinical Operations
Share this job
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
THE ROLE
The Director, Clinical Operations will lead the strategic planning, execution, and continuous improvement of Septerna’s clinical programs across multiple therapeutic areas. This role is pivotal in a dynamic, fast-growing biotech environment and will ensure our clinical trials are delivered with excellence—on time, within budget, and in compliance with regulatory and quality standards.
This is an exciting opportunity with significant room for growth and visibility across the organization. The Director will work closely with senior leadership and cross-functional teams, gaining exposure to all levels of the company while helping to shape the future of Septerna’s clinical operations. The ideal candidate combines deep operational expertise with a patient-first mindset, thrives in collaboration, and brings creativity and structure to a scaling organization.
Key Responsibilities
- Lead operational planning and execution of clinical programs (Phase I–III, including patient-facing , global studies) in alignment with development goals.
- Oversee end-to-end delivery of clinical trials: define timelines, budgets, risk mitigation, resource allocation, and monitoring of results.
- Select, contract, and manage CROs and external vendors; build strong vendor relationships, ensure accountability to scope, budget, milestones, and quality.
- Collaborate across functions — Clinical Development, Regulatory, Biometrics/Data, QA, — to ensure aligned execution and streamlined decision-making.
- Build and mentor a growing clinical operations team; drive team development, foster a culture of learning, accountability, innovation, and high performance.
- Drive operational excellence by creating and implementing fit-for-purpose processes, systems and tools that support a scaling organization — standardizing templates, SOPs, dashboards, KPIs.
- Demonstrate ability to quickly adopt new therapeutic areas, adapt to evolving science and growing strategic demands.
- Bring creative, out-of-the-box thinking to optimize trial design, site operations, patient engagement, vendor strategies and operational efficiency.
- Ensure inspection readiness and adherence to ICH-GCP, SOPs and global regulatory standards; partner with QA to maintain operational integrity.
- Establish and track meaningful metrics (KPIs) to manage progress, proactively manage risks, and drive continuous improvement in trial efficiency and data quality.
Qualifications
- Advanced degree (MS, PharmD, PhD) preferred; or bachelor’s degree in life sciences/clinical research with equivalent robust experience.
- Minimum 10 years’ experience in clinical operations in biotech or pharma, with leadership of multiple global clinical programs (including patient-facing studies).
- Demonstrated success in building and mentoring teams; experience in a growing/scaling environment is highly desirable.
- Proven track record managing CROs/external vendors, budgets/timelines, and operational delivery in a complex setting.
- Effective cross-functional collaborator; strong communicator able to navigate a matrixed, fast-moving organization.
- Experience in or ability to quickly learn new therapeutic areas (endorcrinology, immunology/inflammation, metabolic disease or similar) is strongly preferred.
- Demonstrated process-orientation: able to build, refine and standardize systems, tools, SOPs, dashboards and metrics.
- Strategic thinker with proactive, solution-driven mindset; able to bring innovative thinking to trial operations.
- Results-oriented, detail conscious, and adept at managing multiple priorities under deadlines.
The anticipated salary range for candidates who will work in South San Francisco, CA is $225,000 - $250,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Ready to apply?
Apply to Septerna
Vice President, Clinical Development
Share this job
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
About The Role
Septerna has an exciting new opportunity to join the team as a Vice President, Clinical Development, reporting to the Chief Medical Officer. The VP, Clinical Development will join the Senior Leadership Team and provide key strategic leadership for clinical development strategy, planning, and tactical implementation for all clinical development functions. This position will also serve as the Product Development Team Leader (PDTL) for one or more of Septerna’s clinical stage programs. The PDTL is responsible for product strategy and the design and successful cross-functional implementation of the development plan. S/he will also participate in regulatory interactions and contribute to building relationships with KOLs. Ability to bridge clinical, scientific, and business needs with the aptitude to translate and align business and scientific goals and objectives. Must be a dynamic leader with outstanding strategic, communication, and collaboration skills.
Responsibilities
- Enterprise leader of program strategy, collaborating in a matrixed working environment with clinical operations, regulatory, clinical pharmacology, research, CMC, and other functions to ensure the success of drug development programs.
- Work with key internal and external stakeholders to lead the design and implementation of robust CDPs and integrated development plans to achieve the desired target product profile.
- Guide the development team(s) with aggressive, creative, but realistic approaches to drug development.
- Direct and design fit-for-purpose clinical trials across all phases in drug development; design and draft protocol synopses, clinical trial protocols, amendments, and supporting documents.
- Contribute to IBs, regulatory documents, CSRs, and publications associated with clinical trials.
- Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues.
- Be accountable via collaboration across functions and clinical operations for all relevant timelines and deliverables.
- Collaborate with regulatory affairs to develop high-quality strategic regulatory strategies and engagement.
- Communicate to management and relevant functions any potentially significant issues to the CDP or emerging safety risks in a timely manner.
- Provide strategic consultation and guidance to Research on decision that have significant clinical components and implications.
- Ensure compliance with SOPs, ICH, GCP, and other national and international regulatory requirements.
- In conjunction with the Chief Medical Officer, ensure organizational growth plans for clinical Development scales with Septerna’s current and future needs.
- Mentor and develop more junior physicians and other clinical development staff to successfully advance to higher levels of responsibility.
- Travel to clinical sites, conferences, and regulatory meetings as needed.
Qualifications
- MD or MD/PhD required and 10+ years of experience in Clinical Development or related pharmaceutical capacity.
- Endocrinology/Board Certified Endocrinologist preferred.
- Proven track record of drug development in multiple therapeutic areas.
- Rare disease experience is preferred.
- Excellent communicator with team building and collaboration skills.
- In depth knowledge of drug development process and oversight of clinical trials; well versed in first-in-human trials as well as late phase development and product filing/ registration.
- Has seen and managed significant accelerations and challenges in clinical programs.
- Outstanding management skills a must, both with respect to managing the development team but also evidence of successful enterprise/matrix leadership.
- Demonstrated ability to lead cross-functional teams to make significant recommendations and persuasively present synthesis of team diligence to gain alignment with senior management.
- Expertise in innovative clinical trial design, scientific writing, and the successful implementation of clinical protocols and clinical study reports.
- Experience in all phases of regulatory submissions and interactions; international experience also required, along with negotiation experience with the FDA.
- Comprehensive knowledge of Good Clinical Practices (GCP), ICH, ICJME Guidelines, FDA and other international regulatory body requirements.
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
- Superb presentation skills.
- Thrives in a highly entrepreneurial biotech environment.
The anticipated salary range for candidates who will work in South San Francisco, CA is $380,000 - $420,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
Ready to apply?
Apply to Septerna
Associate Director/Director, GCP Quality Assurance
Share this job
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
THE ROLE
We are seeking an experienced, dynamic, and results-driven Associate Director / Director of GCP Quality Assurance to join our on-site team in South San Francisco. This is a site-based role and not a remote position.
This role is critical in providing both strategic and operational quality leadership for clinical studies and vendor programs, ensuring compliance with ICH GCP and applicable global regulatory requirements, and upholding Septerna’s high standards for data integrity. The ideal candidate will work closely with clinical study teams and cross-functional partners to strengthen quality practices, foster a culture of quality, and maintain a state of continual GCP compliance across all programs.
Responsibilities:
- Provide hands-on quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards.
- Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality, reliable, and inspection-ready data.
- Review and assess key clinical documents and plans (e.g., protocols, monitoring plans, TMF plans, data management plans) to ensure alignment with regulatory requirements and Septerna expectations.
- Interpret and apply regulatory requirements to ensure practical and consistent implementation across studies and programs.
- Partner with SMEs and key development functions to identify risks early, provide guidance, and drive effective resolution.
- Lead and execute GCP audit activities (CROs, vendors, and investigator sites), including planning, reporting, and follow-up on CAPAs.
- Provide day-to-day quality guidance to support study execution, including issue management, deviations, and inspection readiness activities.
- Work cross-functionally to strengthen processes and ensure they remain phase-appropriate and fit-for-purpose as programs evolve.
- Assess vendor performance and quality systems, and support risk-based oversight to ensure compliance, data integrity, and participant safety.
- Contribute to the development, tracking, and reporting of GCP quality metrics to drive continuous improvement.
- Promote and reinforce a strong quality culture through clear communication, training, and active partnership with internal and external stakeholders.
Qualifications
This role requires a balance of strategic leadership and hands-on execution in a lean environment, with the ability to operate independently and build processes as needed.
- Bachelor’s degree in life sciences or a related field; advanced degree preferred.
- 10+ years of experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibility in Clinical QA (may consider 8+ years for exceptional candidates).
- Minimum of 8+ years of direct, hands-on GCP audit experience, including investigator sites, CROs, and clinical vendors.
- Demonstrated ability to independently plan, execute, and lead audits, including CAPA evaluation, follow-up, and closure.
- Strong working knowledge of ICH GCP and applicable global regulatory requirements, with the ability to apply them in day-to-day operations.
- Proven experience providing hands-on GCP quality oversight supporting clinical studies and vendor activities in a dynamic environment.
- Experience authoring and revising SOPs, driving process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose.
- Demonstrated ability to identify and assess risks, interpret regulations, and implement practical, risk-based quality solutions.
- Strong collaboration and communication skills, with the ability to influence and guide cross-functional teams and external partners.
- Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.
- Experience working in a lean or virtual biotech environment is strongly preferred.
The anticipated salary range for candidates who will work in South San Francisco, CA is $205,000 - $240,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Ready to apply?
Apply to Septerna
Vice President, Program and Portfolio Management
Share this job
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
About The Role
Septerna is seeking an experienced Vice President, Program and Portfolio Management to lead our program and portfolio management across the organization. This executive role will drive strategic alignment, operational excellence, and cross-functional execution across Septerna’s pipeline from discovery through clinical development.
The VP will serve as a key strategic partner to executive leadership and the core program teams to ensure that the development programs progress efficiently and that portfolio decisions align with corporate priorities and resource allocation. This leader will establish and scale best-in-class program management capabilities, enabling integrated planning, governance, and decision-making across the portfolio and work closely with the research, preclinical, regulatory, manufacturing, and clinical development functions. The role will be responsible for leading and scaling the project management function as the company grows.
This role reports to the President & COO and works closely with executive leadership and the functional heads across Research, Development, Regulatory, Manufacturing, and Commercial Strategy. This is an in-person role at Septerna’s South San Francisco headquarters.
KEY RESPONSIBILITIES
Portfolio & Program Leadership
- Lead program and portfolio management function across Septerna’s therapeutic pipeline from discovery through clinical development.
- Develop and drive integrated program strategies and ensure programs progress through key development milestones.
- Drive the prioritization of programs and resource allocation discussions with executive leadership.
- Facilitate data-driven decision making, identify critical issues and opportunities, and lead scenario planning across the portfolio.
- Ensure alignment between corporate strategy and goals, program objectives, and operational execution.
Cross-Functional Leadership
- Lead cross-functional program teams spanning research, preclinical development, regulatory, clinical development and operations, manufacturing, and commercial strategy.
- Serve as a strategic thought partner to scientific and development leaders to translate strategy into executable plans.
- Foster collaboration and alignment among diverse stakeholders in a highly matrixed environment.
- Provide clear and consistent communication within and between project teams and executive leadership on decisions and status.
- Provide alliance management support, as needed, for existing and future corporate collaborations.
Executive Governance & Decision Support
- Lead governance committees to ensure program and portfolio oversight.
- Provide executive leadership with clear visibility into program status, key risks, and milestone progress.
- Identify critical path issues, lead cross-functional decision-making processes and ensure timely escalation of critical issues.
- Prepare and deliver strategic program updates for executive leadership and board of directors.
Strategic Planning & Operational Excellence
- Develop and oversee integrated program plans, timelines, resource planning, and budgets across programs.
- Identify portfolio-level risks and opportunities and develop mitigation strategies.
- Implement best-in-class program management processes, tools, analytics, and governance frameworks.
- Build scalable infrastructure for program planning, forecasting, and reporting as the company grows.
- Partner closely with key functions, including Finance on budget and long-range planning processes
Organizational Leadership
- Build, lead, and mentor a high-performing Program Management team that scales with the organization
- Establish standards, processes, and best practices across the organization.
- Promote a culture of accountability, transparency, and execution excellence.
- Contribute to broader organizational strategy and leadership initiatives.
ABOUT YOU
- Advanced degree in a relevant scientific or medical field (PhD, PharmD, MD) or MBA preferred.
- 15+ years of experience in biotechnology or pharmaceutical development.
- Significant leadership experience managing programs across discovery through clinical development.
- Demonstrated experience in portfolio strategy and governance within a biotech or pharmaceutical organization.
- Track record of successfully advancing programs through key development milestones including IND/CTA submissions and early clinical development.
- Deep understanding of the drug development process across discovery, preclinical, regulatory, and clinical stages.
- Strong strategic thinking and decision-making capabilities.
- Experience managing complex cross-functional programs in a matrixed organization and aligning parties on key topics.
- Proven ability to influence senior stakeholders and drive alignment across functions.
- Strong communication and executive presentation skills.
- Ability to navigate ambiguity and lead in a fast-paced biotech environment.
- Highly organized with strong problem-solving and risk-management capabilities.
The anticipated salary range for candidates who will work in South San Francisco, CA is $310,000 - $350,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
Ready to apply?
Apply to Septerna
Director, Program Management
Share this job
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
About the Role
We are seeking an experienced Director of Program Management to join our dynamic team. This role will be critical in driving programs from discovery and development candidate nomination through clinical development, ensuring high-quality, decision-ready execution across research, preclinical, regulatory, and clinical functions.
In this role, you will provide end-to-end program management leadership, serving as the operational owner for assigned programs. You will be accountable for integrated program plans, timelines, risk management, and governance, and will partner closely with scientific and development leaders to align execution with company strategy. As the point of contact for program execution, you will proactively manage risks, facilitate trade-off discussions, and enable informed decision-making at both the team and executive levels.
This position reports to the Senior Director of Program and Portfolio Management and is a full-time, onsite position requiring in-person collaboration with cross-functional teams.
KEY RESPONSIBILITIES
Program Leadership and Coordination
- Lead program management for one or more development programs from preclinical development through clinical stages
- Partner with the cross-functional Product Development Team to define program strategy, conduct scenario planning, and translate strategy into executable plans to achieve program objectives
- Identify and manage program-level risks, assumptions, and interdependencies; lead mitigation planning and issue resolution
- Escalate risks and decision points with clear options and recommendations
- Work with teams to prepare presentations for internal and external meetings (e.g., team presentations, management review, Board of Directors meetings)
Strategic & Operational Planning
- Develop and maintain integrated program plans, including milestones, timelines, budgets, and resource assumptions
- Monitor progress against plans, identify deviations, and implement mitigation strategies or alternative scenarios
- Conduct critical path and dependency analyses to proactively identify risks and bottlenecks
Communication & Stakeholder Management
- Ensure clear, consistent, and transparent communication of program status, key risks, and upcoming milestones
- Align diverse stakeholders around priorities, decisions, and execution plans in a matrixed environment
Process Excellence & Capability Building
- Contribute to the design, implementation, and continuous improvement of program management processes, tools, and templates
- Promote best practices in program planning, governance, and execution across the organization
ABOUT YOU
- Advanced degree relevant to drug discovery/development; Ph.D./ PharmD/MBA preferred
- Minimum of at least 10-15+ years of experience within the Biotech or Pharma industry; prior experience in project management required, specifically in the early clinical development space
- Proven expertise in project planning, execution, and risk management, with a deep understanding of drug development processes, particularly in endocrinology, immunology, CNS
- Demonstrated track record of managing small molecule discovery projects from early research through development candidates and IND/CTA submissions, clinical trial management, and program strategy development
- Experience with commonly used project management tools, including Microsoft Project and Smartsheet
- Ability to execute diverse and novel strategies in a matrix environment; experience managing and influencing complex issues and a variety of key stakeholders
- Demonstrated skill in driving execution and focusing on deliverables
- Strong organizational skills, persistent attention to detail, and ability to work independently and collaboratively to manage timelines and priorities
- Ability to manage complex situations and adapt to changing business needs by prioritizing multiple tasks
- Strong interpersonal and communication skills. Demonstrated ability to collaborate closely with individual project leads/teams and scientific leadership
- Desire to work on a small team in a fast-paced environment
Ready to apply?
Apply to Septerna
Director, Analytical Development
Share this job
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
THE ROLE
We are seeking an experienced and highly motivated Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug discovery and development programs. Reporting to the Vice President, CMC, this individual will fill a critical role as the subject matter expert (SME) and functional lead and will contribute to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities. This position is instrumental in collaborating with and managing a network of consultants and Contract Development and Manufacturing Organization (CDMO) partners to enable our efforts to discover and develop small molecule therapeutics.
Responsibilities
- Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry, form and formulation development, and GMP manufacture.
- Define CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product in alignment with industry standards and regulatory expectations.
- Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability of drug substance and drug product.
- Author and review analytical methods, protocols, reports, batch records, change controls, corrective and preventative actions, deviations, and investigation, including OOS and OOT events.
- Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and the supporting technical documents and remain current on Health Authority guidance and expectations.
- Develop CMC strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals.
- Develop and maintain the quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
- Establish and manage a reference standard program, including oversight of qualification and maintenance of reference standards at CDMOs.
- Support the evaluation, selection, and management of CDMOs to perform process and method development, and GMP manufacture, release testing, and stability studies.
- Represent CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supplies and achieve project goals.
Qualifications
- A BS, MS, or PhD degree in analytical chemistry or related field with a minimum of 16 years, 14 years, or 10 years, respectively, of relevant industry experience with demonstrated increasing responsibilities within analytical development.
- Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GLP and IND-enabling material supplies, through GMP clinical trial supplies and commercialization.
- Demonstrated expertise with analytical method development, phase appropriate method qualification/validation, release and stability testing, and specification development and justification.
- Experience with analytical techniques for small molecules and oral solid dose products. Must demonstrate a strong proficiency in IR, UPLC/HPLC, LC/GC-MS, KF, GC, dissolution, ICP, and microbial limit tests. Must have proficient working knowledge of NMR and solid-state characterization techniques such as particle size distribution and XRPD.
- Strong quality mindset and effective leadership of quality systems, including SOPs, protocols and reports, release and stability data review, OOT and OOS management, Good Documentation Practices, LIMS and cGMP data traceability, Deviations, and Change Management.
- Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
- Proven ability to manage and collaborate with external partners, including consultants and CDMOs.
- Excellent interpersonal and communication skills (written and oral) with the ability to effectively and concisely present data to peers, management, and external groups.
- Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making.
- Able to travel domestically and internationally as needed, up to 20% of the time.
The anticipated salary range for candidates who will work in South San Francisco, CA is $225,000 - $250,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Ready to apply?
Apply to Septerna