Associate Director / Director, CMC Product Development

About the role

Independently manages several clinical development programs of higher complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls (CMC) teams and Product Presentation and Device Strategy Teams (PPDST) of functional representatives from various departments and divisions for projects involving external collaboration partners per Pipeline Commercialization Model (PCM). In the role of PPDST co-chair for Asset Strategy Teams (ASTs) and key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching asset strategy to effectively advance to next key milestone and to deliver a differentiated product. Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders. Partners with key collaborators, incl. Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations. Apprises CMC and Stakeholder Management of strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvals. Supports and implements corporate and division level initiatives and strategies. Proposes, supports and implements and influences initiatives across CMC technical functions. Scope: from late-discovery to tech transfer to commercial manufacturing sites. 0-3 direct reports.

Responsibilities

• Leads teams and partner interactions for new due diligence in-licensing opportunities and successfully transitions leadership for programs where development is internalized.
• Supports and implements corporate and division-level initiatives and strategies
• Proposes, supports and implements and influences initiatives across CMC technical functions.
• Promotes scientific and entrepreneurial thinking, encourages creativity and manages quality and results with respect to science, time, budget and resources.
• Mentors PDD peers and/or other less experienced team members. Responsible for performance and career development of 0-3 direct reports
• Ensures compliance with regulatory, health, safety and environmental requirements. Stay abreast of developments in global technical, regulatory and compliance arena and industry practice.
• Apprises management of plans and risks through regular communications, periodic reviews, in support of global filings, approvals and

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Company Intel

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