Associate Director/Director Pharmaceutical Development

What You'll Do

• Provide strategic pharmaceutical development guidance as the CMC lead to cross functional project teams.
• Develop robust formulations and manufacturing processes to support development and rapid registration of QED products.
• Review development and manufacturing programs at CRO’s/external vendors to ensure compliance with agreed proposals, quality standards and timelines. Review external data.
• Manage drug forecasts and any associated transactions
• Integrate and liaise effectively with CMC team
• Provide formulation and Clinical supply expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).

Responsibilities

• Ability to work effectively and collaboratively on cross functional project teams, in a fast-paced, dynamic environment under tight timelines.
• Develop complex formulation for pediatric indications.
• Work effectively with CDMO's.
• A team player, functional leader, effective listener, clear communicator and quick learner.
• Clear, concise communication style with ability to interact internally and externally.
• Willing to “roll up his/her sleeves and do what it takes” to achieve critical program deliverables.
• Hands-on experience in clinical trials management/study conduct, formulation development and clinical trial manufacturing.
• Knowledge of commercial manufacture

Where You'll Work

Remote with 30% travel expected

Who You Are

• PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharmaceutical industry experience in formulation development and Clinical Supply.
• Expertise in formulation in addition to knowledge of PK/PD principles, ADME concepts, and regulatory documentation and authorship.
• Knowledge of import/export sensitivities.
• Demonstrated 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 are required