Associate Director/Director Pharmaceutical Development

About the role

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 the CMC team. Provide formulation and clinical supply expertise/support in the preparation of regulatory submissions (e.g., IB, IND, NDA).

Responsibilities

• Work effectively and collaboratively on cross-functional project teams in a fast-paced, dynamic environment under tight timelines.
• Develop complex formulations for pediatric indications.
• Work effectively with CDMOs.
• Serve as a team player, functional leader, effective listener, clear communicator, and quick learner.
• Maintain a clear, concise communication style with the ability to interact internally and externally.
• Willing to “roll up your 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.

Requirements

• 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 CROs.
• In-depth knowledge and understanding of CMC Regulatory requirements for US and EU.

Work Environment

Remote with 30% travel expected.

Pay

The anticipated salary range for candidates in California is $223,000 - $239,000 USD. The final salary offered will depend on factors such as experience, industry background, education, location, and interview performance.

Benefits

Financial & Rewards

• Market-leading compensation.
• 401(k) with employer match.
• Employee Stock Purchase Program (ESPP).
• Pre-tax commuter benefits (transit and parking).
• Referral bonus for hired candidates.
• Subsidized lunch and parking on in-office days.

Health & Well-Being

• 100% employer-paid medical, dental, and vision premiums for you and your dependents.
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA).
• Fertility & family-forming benefits.
• Expanded mental health support (therapy and coaching resources).
• Hybrid work model with flexibility.
• Flexible, “take-what-you-need” paid time off and company-paid holidays.
• Comprehensive paid medical and parental leave to care for yourself and your family.

Skill Development & Career Paths

• Opportunities for skill development and internal mobility across discovery, active drug trials, and FDA pipelines.
• Career pathing through regular feedback, continuous education, and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching.
• Performance recognition through financial rewards, peer-to-peer recognition, and growth opportunities.