VP, Pharmaceutical Development and Quality
Direct Hire Full-Time Role
Salary Range: $279,200 - $300,000 per year
Location: San Mateo County, CA - Onsite Role
Job Summary:
You will be accountable for analytical development and operations, supporting the clinical development and commercialization of our pipeline compounds. You will provide technical, organizational, and strategic oversight, collaborating closely with cross-functional teams to ensure seamless execution of end-to-end drug development and manufacturing following our development plan and program timelines. Additionally, you will play a vital role in shaping and executing the overall CMC strategy.
Duties and Responsibilities:
- Lead analytical development and operations from early to late development through commercialization.
- Oversee the execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
- Author, review, and approve relevant CMC sections for global regulatory filings.
- Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan and strategies as needed.
- Serve as a project core team member, communicate CMC strategy and project status to key stakeholders cross-functionally, and assist in driving decision-making.
- Collaborate with cross-functional teams (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK, tox, and program management) to meet CMC and program goals.
- Lead the efforts to assess and identify potential suppliers for analytical development and QC activities supporting drug substance and drug product development and manufacturing with adequate risk assessment.
- Travel to CDMOs and CTLs for vendor assessment and qualification, as well as analytical activities oversight as needed
Requirements and Qualifications:
- Minimum MSc degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or a closely related field
- A PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or a closely related field is preferred.
- 18+ years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase analytical development, and operations experience of small molecules with commercial experience a plus
- Extensive experience in late-phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.)
- Proven track record of strategic leadership and management with at least 10 years in a management role
- Demonstrated project and cross-functional team leadership, as well as people management skills
- Thorough understanding and working experience in innovative drug development and manufacturing concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
- Extensive working experience with management and oversight of the analytical activities at CDMOs or CTLs
- Strong problem-solving skills with strategic and sound technically driven decision-making ability
- Effective written and verbal communication skills and interpersonal skills
Desired Skills and Experience
Pharmaceutical development, analytical development, quality control, CMC regulatory, GMP, ICH guidelines, FDA, analytical chemistry, organic chemistry, physical chemistry
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