Director/Senior Director, CMC
Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in a search for a Director/Senior Director, 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.
- Establishes and executes drug product development strategies.
- Oversees 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.
- Implements robust planning and execution processes to enable efficient and transparent product development efforts across the organization’s portfolio of development stage product candidates.
- Encourages innovative, cross-functional thinking, and engagement of outside expertise as appropriate to further help advance R&D goals.
- 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.
- Performs on-site visits with key manufacturing providers as needed.
- A PhD/MS in pharmaceutical sciences, chemistry, or engineering with significant experience in industry is required.
- Must demonstrate the ability to work effectively in an entrepreneurial, fast-paced environment.
- Requires a comprehensive understanding of all aspects of CMC including medicinal chemistry, formulation development, process development, analytical science, supply chain, regulatory, and quality for small molecule products.
- Must have experience with sterile injectable products.
- Experience with regulatory submissions and interactions with regulatory agencies regarding CMC issues at all stages of product development are required.
- Must have a proven track record of successfully progressing drug candidates from IND through NDA submission.
- Excellent analytical, communication, presentation, writing, and leadership skills are required.
- Experience in writing CMC regulatory documents is highly preferred.
- Biotech and outsourcing experience are desirable.
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.