Senior Vice President, CMC
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Vice President, CMC.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Designs and champions the CMC roadmap for the company, including product development budgets and timelines.
- Builds an in-house CMC group from scratch.
- Establishes a drug substance and drug product development strategy and leads the execution of the strategy including the design and execution of relevant studies and identification, contracting and management of CROs and CMOs.
- Oversees and reviews all relevant CMC sections for regulatory submissions to support our product candidates.
- Reviews study reports, manufacturing process documentation, investigator brochures, clinical study protocols, and clinical trial documentation for compliance with appropriate regulations and guidelines for CMC related issues.
- Identifies execution risks and develops contingency plans as needed.
- Partners with the executive team to ensure timely, data-driven decisions are made with regard to CMC and drug manufacturing.
- Builds and leads the CMC group, including process chemistry, formulation development, and analytical science.
- Actively participates and contributes to project and program development teams.
- Implements robust planning and execution processes to enable efficient and transparent product development efforts across the organization’s portfolio of development stage product candidates.
- Creates and delivers the overall R&D strategy and other key business priorities.
- Encourages innovative, cross-functional thinking, and engagement of outside expertise as appropriate to further help advance R&D goals.
- Develops and maintains robust short-term and long-range CMC plans to support the broader organizational objectives and prepare the company for a potential product launch.
- Ensures effective communication and alignment of efforts with internal and external constituents, including clinical, regulatory, finance and quality assurance.
- Provides CMC leadership for company interactions with regulatory agencies.
- Works collaboratively to proactively identify and mitigate product development and delivery risks.
- Performs on-site visits with key manufacturing providers as needed.
- A PhD or Master’s Degree in pharmaceutical sciences, chemistry, or engineering with significant experience in industry is required.
- The demonstrated ability to be effective in an entrepreneurial, fast-paced environment is required.
- Must have a comprehensive understanding of all aspects of CMC including process chemistry, formulation development, analytical science, supply chain, regulatory, and quality for small molecule products.
- Experience with regulatory submissions and interactions with regulatory agencies regarding CMC issues at all stages of product development is required.
- Requires a proven track record of successfully progressing drug candidates from IND through NDA submission.
- Must have experience in writing CMC regulatory documents.
- Outsourcing experience and cGMP knowledge is required.
- Must have excellent analytical, communication, presentation, writing, and leadership skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.