ED or VP of CMC
2 days ago
Job Title : Executive Director (ED) or Vice President (VP) of CMC – Drug Product
Location: Southern California - Orange County or San Diego
Salary Range: $260k-$320k based on experience
About the organization:
The organization is advancing a best-in-class drug candidate currently in clinical phase 3 trials for the treatment of gout and tophaceous gout. We are driven by our mission to improve patient outcomes with innovative therapies, and we are seeking a highly skilled and experienced leader to join our team as Executive Director or Vice President in CMC, focusing on drug product development through phase 3, registration, NDA filing, and commercialization.
Why Join Us?
Join our team and you will be a part of an innovative team that is making a real difference in the lives of patients with gout and tophaceous gout. As a key leader, you will have the opportunity to shape the future of our breakthrough therapy and contribute to its successful global launch.
Position Overview
The ED/VP of CMC will lead and oversee all aspects of drug product development, ensuring seamless progression from clinical phase 3 trials to product registration, New Drug Application (NDA), and commercialization. The ideal candidate will have extensive experience in oral small molecules, an in-depth understanding of CMC regulatory requirements, and a proven track record of working with global CDMOs. This is a hands-on leadership role, requiring a candidate who is willing to roll up their sleeves and actively drive projects forward.
Key Responsibilities:
- Lead and manage the drug product development for phase 3 trials, ensuring alignment with company timelines and regulatory requirements.
- Oversee preparation for product registration, including NDA submission, with a focus on compliance with ICH and FDA guidelines.
- Write and review CMC Module 3 sections of the NDA dossier for US FDA, EMA, and other regulatory submissions.
- Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, clinical supply and API manufacturing to ensure the successful progression of the drug candidate.
- Establish and maintain strong partnerships with CDMOs across Asia, the US, and Europe to ensure high-quality drug product development, manufacturing, and supply chain management.
- Provide technical expertise and strategic direction for CMC-related activities, including formulation development, process optimization, and technology transfer.
- Ensure compliance with global regulatory standards and guidelines throughout the drug development and commercialization processes.
- Drive continuous improvement initiatives to optimize manufacturing processes, cost-effectiveness, and scalability for commercial production.
- Serve as a key CMC representative in meetings with regulatory agencies, partners, and internal stakeholders.
Qualifications:
- D. or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 15+ years of relevant experience in oral small molecule drug development on CMC.
- In-depth knowledge of ICH, FDA, and other global regulatory guidelines for drug product development and commercialization.
- Proven experience in writing and compiling Module 3 of the CMC section for NDA filings with US FDA, EMA, and other health authorities.
- Proven experience working with CDMOs in Asia, US, and Europe.
- Demonstrated success in leading drug product development from phase 3 through NDA submission and commercialization.
- Hands-on, results-driven leader with a willingness to roll up sleeves and ensure deliverables are met.
- Strong communication, leadership, and collaboration skills, with the ability to work effectively in a fast-paced, dynamic environment.
Candidate must reside in California
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