Senior Director, Formulation & Drug Product Development

Terns Pharmaceuticals•Foster City, CA

59d•$270 - $290

About The Position

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 to late-stage programs, we are expanding our CMC organization to support late-stage development and commercial readiness. The Senior Director, Formulation & Drug Product Development will lead formulation strategy and execution across Terns' portfolio. This role is responsible for formulation design, process development, technology transfer, and oversight of global CDMOs to ensure timely, compliant delivery of high-quality drug products. The ideal candidate is a hands-on, strategic leader with deep expertise in small molecule formulation development and experience transitioning programs from clinical to commercial stages.

Requirements

Ph.D. or M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
12+ years of relevant pharmaceutical industry experience, with at least 10 years in formulation and drug product leadership roles.
Demonstrated success advancing small molecule compounds from clinical to late-stage/commercial stages.
Expertise in oral solid dosage forms; experience with enabling technologies (e.g., amorphous solid dispersions, lipid-based systems) strongly preferred.
Experience in late-stage development to support submission of NDA filing and approval.
Proven track record managing global CDMOs, including technology transfer and validation.
Strong knowledge of global CMC regulatory requirements (FDA, EMA, ICH), cGMPs, and quality systems.
Strategic thinker with technical depth and operational execution strength.
Ability to travel both domestically and internationally to CDMOs and other vendors.
Excellent communication, collaboration, and vendor management skills.
Comfortable in a fast-paced, entrepreneurial biotech environment.
Willingness to travel up to 35%, including to CDMO and manufacturing sites for vendor assessment, qualification, audits, and manufacturing oversight as needed.

Responsibilities

Define and lead drug product development strategy for Terns' programs.
Develop robust, scalable formulations and drug product manufacturing 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 for investigational drugs (e.g., solubility enhancement, stability optimization, modified release, fixed dose combinations, etc.).
Lead pre-formulation activities, formulation and process development, process optimization, scale-up, clinical manufacturing, and technology transfer for solid oral dosage forms and other relevant drug products.
Oversee multiple activities in parallel at globally based CDMOs, ensuring technical excellence, maintaining aggressive timelines, and reducing cost of goods.
Partner with drug substance, analytical, regulatory, and quality teams to support validation activities and PPQ readiness.
Support regulatory filings, queries from health agencies and regulatory interactions related to drug product development.
Collaborate closely with Drug Substance, Analytical Development, Quality, Regulatory, and Clinical Supply Chain functions.
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.
Lead and mentor formulation scientists or external consultants supporting internal programs.
Contribute to building a high-performing, integrated CMC organization that supports Terns' growth to a commercial-stage company.