Associate Director, Early Stage Drug Product Development

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA‑approved treatments for Parkinson's disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid‑to‑late‑stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier‑stage programs that address other underserved patient needs.

Seeking talent near:
Princeton, NJ;
San Diego, CA

The Associate Director in the Early Stage Drug Product Development organization is responsible for developing pharmaceutical formulations primarily intended for early‑stage clinical trials and preclinical animal studies. The role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent focuses on formulation strategies tailored to early development phases, ensuring candidates are suitably prepared for initial safety and efficacy evaluations, and collaborates with research scientists and external partners to address technical challenges and advance promising compounds toward clinical readiness.

• Designs and develops pharmaceutical formulations to support early‑stage clinical trials, providing acceleration options such as on‑site compounding.
• Evaluates and validates new drug product CSPs, oversees operations at existing suppliers, and initiates and manages supplier contract agreements as necessary.
• Coordinates and supervises the development of clinical formulations and finished dosage forms at CSPs, serving as person‑in‑the plant at CSP sites.
• Plans project‑related scientific and technical activities, interprets results, evaluates data, formulates conclusions, and writes and presents technical reports.
• With Translational Sciences teams, plans the conduct of preclinical and toxicological studies and develops requisite formulations for these studies, considering develop ability of new drug candidates.
• Develops phase‑appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies using resource‑sparingly approaches such as compounded formulations and/or on‑site preparations.
• Conducts physicochemical characterizations of new drug candidates to support develop ability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions; reviews MBRs, BPRs, development reports and other documents prepared by CSPs.
• Liaises with the CMC team, late‑stage formulation team, and formulation development management to establish the development strategy for new drug candidates.
• Adheres to cGMP work practices and collaborates with Quality Assurance and regulatory teams to prepare health authority submissions for early clinical trial applications (e.g., IND, CTA, IMPD).
• Other responsibilities as assigned.

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered. Minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development, with some leadership experience desired. Demonstrated success in formulations and dosage form development, and experience authoring technical reports and CMC sections for regulatory filings.

Must possess:

• Comprehensive understanding of physicochemical characterization of new drug candidates to assess develop ability, early‑stage clinical formulation, dosage form formulation, and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at aligning resources across multiple functional areas to achieve goals.
• Flexibility to travel domestically and internationally.

Regularly required to stand;…