Description

The VP of Pharmaceutical Development & Quantitative Sciences will have strategic oversite of the Drug Product Development, Technical Content Strategy supporting regulatory filing and Data Science teams. Working in conjunction with CMC teams, this position is responsible for developing strategic plan at each state of program development to prepare for global regulatory filings and driving end to end data analysis and trending insights. This position will partner closely with Global Supply Chain, QA/QC, Technical Development (MS&T), and Regulatory Affairs, and CMC teams to implement new programs and manage changes.

Primary responsibilities include:

Leadership and Strategy:

• Lead internal strategy and framework development for regulatory filing, working in close partnership with CMC Development & Strategy and Manufacturing functions. Defining the requisites at each stage of program development.
• Drive execution of functional activities according to agreed program plans and strategies (activities/deliverables, timeline, regulatory expectations)
• As a member of TechOps Leadership team (TOLT), accountable for representation of line functions on cross functional leadership and  appropriate sub-teams and ensuring Tech Ops input into program strategy.
• Provide strategic oversight of Drug Product & Formulation development function
• In tune with the latest industry trends, advancements in data analytics, statistical modeling, and regulatory guidelines related to CMC.

Data Analysis and Modeling:

• Facilitate end-to-end (starting to finished goods) data analytics and trending across all functions to support process optimization and cohesive regulatory filing conditions.
• Establish and evolve standards and practices for the management of analytics pipelines, modeling, analysis, visualization, and presentation of data.
• Provide team leadership in developing and delivering the end-to-end data analytics and statistical science core capability that supports Sarepta’s CMC development lifecycle, from process development through GMP commercial manufacturing and regulatory approval.
• Partner with all CMC functions to assess needs, identify opportunities, and implement approaches that enable access and use of data, including process trending, process monitoring, design of experiments, etc.

Regulatory Compliance:

• Dedicated internal support to the Technical Operations team to provision CMC content strategy per program to support global regulatory filings.
•  Review, Approve and Influence CMC regulatory submission documents for clinical and commercial products
• Collaborate with regulatory affairs teams and oversee regulatory submissions related to CMC, providing scientific expertise and quantitative analyses as needed.
• Oversee and Support inspections and audits related to CMC quantitative sciences, addressing any findings or recommendations.
• Review and approve drug product sections of regulatory filings

Desired Education and Skills: 

• M.S./Ph. D in Pharmaceutical Sciences, Chemical/Biochemical Engineering, Statistics, Mathematics or a related discipline with technical experience relevant to areas within the quantitative sciences disciplines
• Extensive experience (15+ years) in the pharmaceutical industry, with a focus on CMC/ development, quantitative sciences, process development, or manufacturing with 7 years in a leadership role as an effective people manager.
• Experience in Gene Therapy and RNA field a plus
• Strong technical/scientific experience in product development and commercialization
• Well-developed understanding of formulation approaches
• Experience creating and developing novel drug delivery applications to address difficult formulation challenges
• Knowledge and experience using biochemical or biophysical methods to characterize AAV-based viral vectors
• Strong leadership and interpersonal skills with the ability to work cross-functionally and communicate effectively across CMC functional areas
• Experience with regulations and requirements such as cGMP, ICH, USP, JP and global CMC regulatory expectations
• Experience authoring regulatory filings and interacting directly with Health Authorities
• Domestic and international travel required

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#LI-Hybrid

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $288,000 - $360,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.