Senior Director, Formulation & Drug Product Development

Location:Foster City CA
Reports to:SVP CMC
Travel:Up to 35%

Who We Are:
Terns Pharmaceuticals is a clinical-stage oncology company committed to developing transformative therapies that improve the lives of patients with cancer. As we advance from early clinical development tolate-stage programs we are expanding our CMC organization to support late-stage development and commercial readiness.

Who We Are Looking For:
TheSenior Director Formulation & Drug Product Developmentwill lead formulation strategy and execution across Terns portfolio. This roleis responsible forformulation design process development technology transfer and oversight of global CDMOsto ensuretimely compliant delivery of high-quality drug products.

The ideal candidate is a hands-on strategic leader with deepexpertisein small molecule formulationdevelopmentand experience transitioning programs from clinical to commercial stages.

What Youll Do:

• Define and lead drug product development strategy for Terns programs.
• Develop robust scalable formulations anddrug productmanufacturing processes that ensure product quality.
• Establish specifications and control strategies aligned with global regulatory and quality expectations.
• Serve as a scientific and technical expert in formulation challenges forinvestigationaldrugs (e.g. solubility enhancement stability optimizationmodifiedrelease fixed dose combinations etc.).

Program Execution & Vendor Management

• Leadpre-formulation activitiesformulationand process development process optimization scale-up clinical manufacturingand technology transfer for solidoraldosage forms and other relevant drug products.
• Overseemultipleactivitiesin parallelatglobally basedCDMOs ensuring technical excellencemaintainingaggressive timelines andreducingcost of goods.
• Partner withdrug substanceanalytical regulatory and quality teams to support validationactivitiesand PPQ readiness.
• Supportregulatoryfilings queries from healthagenciesand regulatory interactions related to drug product development.

Cross-Functional Collaboration

• Collaborate closely withDrug Substance Analytical Development Quality Regulatory and Clinical SupplyChainfunctions.
• Provide CMC input to global regulatory submissions and health authority meetings.
• Ensure reliable delivery of clinical trial supplies and transition to commercial-scale operations.
• Strong organizational skills with the ability to effectively manage multiple priorities and effectively communicate both written and verbally all drug product related activities to key stakeholders.

Leadership & Team Development

• Lead and mentorformulationscientists or external consultants supportinginternalprograms.
• Contribute to building a high-performing integrated CMC organization that supports Terns growth to a commercial-stage company.

What Youll Bring to Our Team:

Education

• Ph.D. or M.S. inPharmaceutical Sciences Chemistry Chemical Engineering or relatedfield.

Experience

• 12 years of relevant pharmaceutical industry experience with at least10years in formulation and drug product leadership roles.
• Demonstrated success advancingsmall moleculecompoundsfrom clinical tolate-stage/commercial stages.
• Expertisein oral solid dosage forms; experience with enabling technologies (e.g. amorphous solid dispersions lipid-based systems) strongly preferred.
• Experience in late-stage developmentto support submission of NDA filingand approval.
• Proventrack recordmanagingglobalCDMOs including technology transfer and validation.
• Strong knowledge of global CMC regulatory requirements (FDA EMA ICH)cGMPs and quality systems.

Skills & Attributes

• Strategic thinker with technical depth and operational execution strength.
• Ability to travelboth domestically andinternationally to CDMOs and other vendors.
• Excellent communication collaboration and vendor management skills.
• Comfortable in afast-paced entrepreneurial biotechenvironment.
• Willingness to travel up to35%including toCDMO and manufacturing sitesfor vendor assessment qualification audits and manufacturing oversight as needed.

• Be a key leader shaping the next stage of Terns growth as we advance into late-stage development.
• Work in a science-driven collaborative culture that values innovation and accountability.
• Join a mission-driven team dedicated to improving outcomes for patients with cancer worldwide.

At Terns youll have the opportunity to make a lasting impact at a company on the forefront of transforming oncology and youll be a key leader shaping the next stage of Terns growth as we advance into late-stage development. Youll work alongside a passionate and experienced team driven by science and innovation and committed to improving the lives of patients. This is a unique opportunity to contribute to the growth and success of a promising biopharma company at a pivotal moment in its journey.

***

The expected base pay for this full-time exempt positionis $270 290K bonus equity benefits. At Terns our salary ranges aredeterminedby role level and location. The ranges are subject tochangeand individual pay within that range can vary for several reasons including location skills/capabilities experience and available budget.

Terns Pharmaceuticals is committed to being an Equal Opportunity Employer and our policy is to provide equal employment opportunities to all applicants and employees without regard to race color creed religion sex sexual orientation gender identity marital status citizenship status age national origin ancestry disability veteran status or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity.