(Senior) Director, Drug Product CMC

About the role

The (Senior) Director of Drug Product within the CMC group will lead nonclinical and clinical formulation development, manage external vendors (CROs/CDMOs), and support drug product development from Phase I to Phase III. This position reports to the Executive Director, CMC, and requires domestic and international travel.

Responsibilities

• Directly manage external vendors (CROs/CDMOs) to execute physiochemical characterization and pre-formulation studies for New Chemical Entities (NCEs).
• Design and develop nonclinical formulations (oral, subcutaneous, intravenous) to ensure stability, bioavailability, and effective drug delivery in animal models.
• Oversee execution of nonclinical formulation stability and compatibility studies.
• Support clinical formulation development of oral solid dosage forms as needed.
• Author, review, and approve development and dose preparation protocols and reports.
• Review formulation-related sections of protocols and reports for PK, PD, and safety studies.
• Represent CMC in cross-functional meetings, providing guidance on nonclinical formulation, DS/DP stability, and supply.
• Coordinate shipments to support nonclinical and clinical development supply requirements.
• Assist in compiling formulation-related documentation for regulatory submissions (e.g., IND, CTA).
• Collaborate with cross-functional CMC groups, including discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, and regulatory teams.

Requirements

• Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. strongly preferred.
• 10+ years of drug product/formulation development experience supporting nonclinical and clinical programs, with expertise in oral, subcutaneous, and intravenous dosage forms for small molecules.
• Deep technical expertise in developing and manufacturing poorly soluble (BCS Class II/IV) compounds, including formulation strategies for oral and parenteral delivery.
• Strong understanding of pharmaceutical sciences and engineering principles for liquid and solid dosage form development from early-stage through clinical and commercial manufacturing.
• Working knowledge of analytical and solid-state characterization techniques (HPLC/UPLC, XRPD, DSC, TGA, DVS, etc.).
• Experience managing external development and manufacturing partners (CROs, CDMOs, CMOs) and understanding of cGMP requirements.
• Proven ability to lead multiple complex programs in a fast-paced environment with strong project management and organizational skills.
• Excellent communication, presentation, and interpersonal skills to influence stakeholders and build partnerships.
• Strategic, hands-on leadership with strong decision-making, problem-solving, and resilience.
• Willingness and ability to travel domestically and internationally as needed.

Pay

The annual base salary range for the Director level position is $150,000 to $225,000. The range for the Sr. Director level position is $165,000 to $250,000. Individual compensation will be determined based on qualifications, skills, experience, job knowledge, and location. This role is also eligible for a discretionary annual bonus.

Benefits

• Comprehensive benefits package, including company-sponsored medical, dental, vision, and life insurance.
• 401(k) plan.
• Generous paid time off.
• Health and wellness program.

Schedule

This is a full-time, exempt position based in the US, with occasional travel required.