Associate Director – Pharmaceutical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer strategic guidance for pharmaceutical development as the CMC lead for cross-functional project teams.

• Create robust formulations and manufacturing processes to aid in the development and swift registration of QED products.

• Assess development and manufacturing programs at CROs and external vendors for adherence to proposals, quality standards, and schedules.

• Analyze external data.

• Oversee drug forecasts and related transactions.

• Collaborate and communicate effectively with the CMC team.

• Provide expertise in formulation and clinical supply to support regulatory submissions, including IB, IND, and NDA.

• Develop intricate formulations for pediatric applications.

• Work efficiently with CDMOs.

• Manage clinical supply, formulation development, and manufacturing processes at CROs.

⛳️ Requirements

• PhD or an advanced degree in Chemistry or Pharmacy.

• Over 7 years of experience in the bio/pharmaceutical industry focusing on formulation development and clinical supply.

• Strong expertise in formulation.

• Familiarity with PK/PD principles and ADME concepts.

• Knowledge of regulatory documentation and authorship processes.

• Understanding of import/export sensitivities.

• Proven capability to manage clinical supply, formulation development, and manufacturing at CROs.

• Comprehensive knowledge of CMC regulatory requirements for both the US and EU.

• Ability to collaborate effectively on cross-functional project teams in a fast-paced, dynamic environment under stringent timelines.

• Practical experience in managing clinical trials, formulation development, and clinical trial manufacturing.

• Insight into commercial manufacturing processes.

• Clear and concise communication skills, capable of engaging with both internal and external stakeholders.

• Commitment to taking ownership of critical program deliverables.

🏝️ Benefits

• Competitive compensation package.

• Annual performance-based bonus.

• Company equity options.

• 401(k) plan with employer matching contributions.

• Employee Stock Purchase Program (ESPP).

• Pre-tax commuter benefits for transit and parking.

• Referral bonuses for successfully hired candidates.

• Subsidized lunches and parking on in-office days.

• Comprehensive employer-paid medical, dental, and vision premiums for you and your dependents.

• Health Savings Account (HSA) with annual contributions from the employer.

• Flexible Spending Accounts (FSA).

• Benefits for fertility and family planning.

• Enhanced mental health support including therapy and coaching resources.

• Hybrid work model offering flexibility.

• Flexible paid time off with a “take-what-you-need” approach and company-paid holidays.

• Comprehensive paid medical and parental leave.

• Opportunities for skill enhancement and internal mobility.

• Structured career development through regular feedback, continuous education, and professional development programs via LinkedIn Learning, LifeLabs, and BetterUp Coaching.

• Financial rewards, peer recognition, and growth opportunities.