Associate Director, Early Stage Drug Product Development
Acadia Pharmaceuticals
8 hours ago
On-site
San Diego, CA
Clinical Research and Development
Position Summary
The Associate Director in Early Stage Drug Product Development is responsible for developing pharmaceutical formulations primarily for early-stage clinical trials and preclinical animal studies. The role supports drug discovery through physicochemical characterization to select developable candidates for safety/efficacy evaluation and clinical readiness. Manages activities at Contract Service Providers (CSPs) and helps resolve complex technical issues to reduce risk and accelerate introduction of new chemical entities.
Primary Responsibilities
- Design and develop pharmaceutical formulations to support early stage clinical trials (including on-site compounding and other rapid options).
- Evaluate/validate new drug product CSPs; oversee existing suppliers; initiate and manage supplier contract agreements.
- Coordinate and supervise clinical formulations and finished dosage forms at CSPs (serves as person-in-the-plant).
- Plan and execute project scientific/technical activities; interpret data; write and present technical reports.
- With Translational Sciences, plan preclinical and toxicology studies and develop required formulations.
- Develop phase-appropriate formulations for FIH, Phase 1, and POC studies using resource-sparing approaches.
- Perform physicochemical characterizations to support developability assessments.
- Author/review technical reports and regulatory submission documents; review CSP-prepared MBRs/BPRs/development reports.
- Liaise with CMC and late-stage formulation teams to establish formulation development strategy.
- Adhere to cGMP/GXP; partner with Quality Assurance and collaborate with regulatory teams for early trial applications (IND, CTA, IMPD).
Education/Experience/Skills (Required)
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field.
- Minimum 10 years’ progressively responsible experience in formulation and manufacturing process development; leadership experience desired.
- Demonstrated success in formulation/dosage form development; experience authoring technical reports and CMC sections for regulatory filings.
Must Possess
- Comprehensive understanding of physicochemical characterization and early-stage formulation/package development.
- Extensive knowledge of cGMPs.
- Skilled at managing CSPs.
- Strong verbal and written communication.
- Ability to align resources across functional areas.
- Flexibility to travel domestically and internationally.
Physical Requirements
- Regular standing/walking/sitting; ability to occasionally lift/move up to 20 lbs; ability to travel domestically and internationally.
Benefits (if applicable as stated)
- Medical, dental, vision insurance; employer-paid life/disability/business travel/EAP.
- 401(k) with fully vested match 1:1 up to 5%.
- Employee Stock Purchase Plan (2-year purchase price lock-in).
- 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave.
- Tuition assistance.
- Discretionary bonus and equity awards; salary range $154,000–$192,700 USD.
The Associate Director in Early Stage Drug Product Development is responsible for developing pharmaceutical formulations primarily for early-stage clinical trials and preclinical animal studies. The role supports drug discovery through physicochemical characterization to select developable candidates for safety/efficacy evaluation and clinical readiness. Manages activities at Contract Service Providers (CSPs) and helps resolve complex technical issues to reduce risk and accelerate introduction of new chemical entities.
Primary Responsibilities
- Design and develop pharmaceutical formulations to support early stage clinical trials (including on-site compounding and other rapid options).
- Evaluate/validate new drug product CSPs; oversee existing suppliers; initiate and manage supplier contract agreements.
- Coordinate and supervise clinical formulations and finished dosage forms at CSPs (serves as person-in-the-plant).
- Plan and execute project scientific/technical activities; interpret data; write and present technical reports.
- With Translational Sciences, plan preclinical and toxicology studies and develop required formulations.
- Develop phase-appropriate formulations for FIH, Phase 1, and POC studies using resource-sparing approaches.
- Perform physicochemical characterizations to support developability assessments.
- Author/review technical reports and regulatory submission documents; review CSP-prepared MBRs/BPRs/development reports.
- Liaise with CMC and late-stage formulation teams to establish formulation development strategy.
- Adhere to cGMP/GXP; partner with Quality Assurance and collaborate with regulatory teams for early trial applications (IND, CTA, IMPD).
Education/Experience/Skills (Required)
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field.
- Minimum 10 years’ progressively responsible experience in formulation and manufacturing process development; leadership experience desired.
- Demonstrated success in formulation/dosage form development; experience authoring technical reports and CMC sections for regulatory filings.
Must Possess
- Comprehensive understanding of physicochemical characterization and early-stage formulation/package development.
- Extensive knowledge of cGMPs.
- Skilled at managing CSPs.
- Strong verbal and written communication.
- Ability to align resources across functional areas.
- Flexibility to travel domestically and internationally.
Physical Requirements
- Regular standing/walking/sitting; ability to occasionally lift/move up to 20 lbs; ability to travel domestically and internationally.
Benefits (if applicable as stated)
- Medical, dental, vision insurance; employer-paid life/disability/business travel/EAP.
- 401(k) with fully vested match 1:1 up to 5%.
- Employee Stock Purchase Plan (2-year purchase price lock-in).
- 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave.
- Tuition assistance.
- Discretionary bonus and equity awards; salary range $154,000–$192,700 USD.