Associate Director/Director Pharmaceutical Development
$223,000–$239,000 year
RemoteUnited States
Job Summary
Provide strategic pharmaceutical development guidance as the CMC lead to cross-functional project teams, developing robust formulations and manufacturing processes to support QED product registration. Review development and manufacturing programs at CROs and external vendors to ensure compliance with quality standards and timelines, while integrating with the CMC team to prepare regulatory submissions including IND and NDA. Manage drug forecasts and transactions, and develop complex formulations for pediatric indications. Work effectively with CDMOs in a fast-paced environment under tight timelines, requiring hands-on experience in clinical trial manufacturing and regulatory documentation for US and EU markets. Remote with 30% travel expected.
Required Qualifications
- PhD or advanced degree in Chemistry or Pharmacy
- 7+ years of bio/pharmaceutical industry experience in formulation development and Clinical Supply
- Expertise in formulation
- Knowledge of PK/PD principles
- Knowledge of ADME concepts
- Knowledge of regulatory documentation and authorship
- Knowledge of import/export sensitivities
- Ability to manage Clinical Supply, Formulation development and manufacture at CRO's
- In-depth knowledge and understanding of CMC Regulatory requirements for US and EU
- Remote work capability
- 30% travel capability
Desired Qualifications
- Hands-on experience in clinical trials management/study conduct
- Knowledge of commercial manufacture
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