Note: The job is a remote job and is open to candidates in USA. Apnimed is a clinical-stage pharmaceutical company developing oral medications for sleep apnea and related disorders. The Senior Director, CMC Operations will lead project, alliance, and financial management activities within Technical Operations, coordinating CMC development and commercialization activities across internal teams and external service providers.
Responsibilities
- Drive alignment across Technical Operations, Quality Assurance, and Regulatory teams to clarify and communicate project priorities, progress, challenges, and resolution of issues
- Manage the flawless execution of CMC activities associated with the development and commercialization of company portfolio assets
- Provide alliance management oversight of service providers (CDMOs) to ensure work is delivered within contracted scope, schedule, and budget
- Manage escalation to appropriate internal and external stakeholders to ensure timely resolution of issues associated with Technical Operations activities
- Prepare and monitor Technical Operations budgets and communicate status to internal and external finance colleagues
- Bridge CMC core teams and sub-teams to ensure coordination of technical activities and timelines
- Create and maintain effective project communication tools (e.g., meeting minutes, action trackers, timelines) and provide timely updates to stakeholders
- Adhere to applicable regulations, including FDA, EMA, ICH, and Apnimed policies
Skills
- Degree in life sciences, pharmaceutical sciences, program management, or related field
- Minimum 10 years of pharmaceutical industry experience with a proven track record of managing multiple activities and projects simultaneously
- Hand-on experience with complex budget development and oversight
- Practical understanding of cGMP, ICH, FDA, and EMA guidelines for pharmaceutical drug development
- Demonstrated ability to interact effectively with CDMOs to ensure deliverables are met
- Ability to plan for and manage simultaneous priorities and changing deadlines in a fast-paced environment
- Excellent oral and written communication skills
- Proficiency in the use of MS Word, PowerPoint, Excel, Outlook, Smartsheet, and other commonly used pharmaceutical industry software
- Excellent leadership, communication, and problem-solving skills
- Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders
- Excellent communication and presentation skills to efficiently relay information to staff, project teams, executive leadership, and other key stakeholders
- Proven ability to work independently and be self-motivated
- Must be able to travel as necessary
Benefits
- 401(k) with company match
- Generous time off for vacation
- Generous healthcare benefits
- Flexible working environment
- Motivated and experienced team
- Winner of 2024 and 2025 Boston Business Journal Best Places to Work
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