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CMC Program Management Director
2 months ago
We are seeking a highly experienced and skilled Director/Senior Director to lead our CMC Program Management team at Avidity Biosciences. The ideal candidate will have a strong background in CMC program management, with a proven track record of driving successful product launches and regulatory approvals.
Key Responsibilities- Develop and execute strategic plans for CMC program management, ensuring timely and successful delivery of products to market.
- Lead cross-functional teams to coordinate CMC validation activities, partnering with CMC Lead PMs and subject matter experts to ensure successful BLA applications and launches.
- Monitor and report on validation/BLA preparedness, including preparation of phase gate packages.
- Establish strong relationships with internal and external partners to build high-performing teams that drive efficiency and resolve challenges.
- Lead matrix teams in a regulated GMP environment, partnering with Quality and Regulatory colleagues to ensure products meet quality and safety specifications.
- Develop and implement risk management plans for CMC programs, proactively identifying risks and developing strategies to address them.
- Build and monitor fully integrated project schedules, capturing all manufacturing activities and resources needed to meet corporate goals.
- Partner with PM and CMC Leadership to mentor and develop a high-performing team of program managers, fostering a culture of collaboration, accountability, and innovation.
- Advanced degree in Life Sciences or a related field (MS or PhD preferred).
- Minimum of 10 years of experience in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role in CMC program management.
- Strong leadership, communication, and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
- Expertise in risk management, resource allocation, and performance monitoring.
- Proven track record of contributing to successful product regulatory approval and launches in the biotech/pharma industry.
- Strong understanding of drug development, including in-depth knowledge of CMC functions and the strategic and operational requirements from IND to commercial launch.
- Project management skills, along with problem-solving, negotiation, conflict resolution, influencing, and team-building skills.
- Technical proficiency with project management tools, strong computer skills, and experience with software such as MS Project, Smartsheet, Excel, and SharePoint.
- A background in rare diseases, oligonucleotide, or biologics therapeutics.
- Project Management Professional (PMP) or similar certification.
- Strong analytical skills with the ability to leverage data for strategic decision-making.
- A competitive salary range of $210,000 - $260,000, commensurate with experience, skillset, internal equity, and market factors.
- A comprehensive benefits package, including medical, dental, vision, and LTD, as well as four weeks of time off.
- A commitment to learning and development, including job-specific training, education reimbursement, and professional growth opportunities.
