Description:

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: 

• Represents all CMC areas on the AST serving as spokesperson for the CMC project team and ensures information flow among the AST and all line functions. Ensures high quality science, technology, deliverables, and certifies compliance with global regulatory and quality requirements. Participates in meetings with Regulatory Authorities, responds to regulatory queries, and participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. timelines, risks and mitigations in collaboration with line functions and AST
• Leads PPDST and/or CMC development teams for assigned projects: schedules meetings, develops agendas, issues highlights, identifies risks and develops mitigation plans with technical functions. Conducts periodic reviews to ensure that phase transition criteria are met in the most efficient and resource effective manner. Asset modalities may include new chemical entities (NCEs), new biological entities (NBEs), antibody-drug-conjugates (ADCs), toxins, and gene and cell therapies, incl. combination with complex delivery device constituents
• Reviews contracts with Third Party Manufacturers and consultants. Develops budget needs in collaboration with AST, obtains resources from functional areas and stays within the approved funding. Drives legal and financial aspects of outsourcing, contracts, and statements of work (SOW). Demonstrates excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrates strong negotiating, influencing, and leadership skills.
• Leads teams and partner interactions for new due diligence in-licensing opportunities and successfully transitions leadership for programs where development is internalized.
• Manages several clinical development programs of higher complexity independently utilizing matrix management approach. Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieve efficiency with respect to time, and budget. Provides feedback and input to functional managers and identifies growth needs for team members.
• Ensures strategic alignment with other key Development Sciences functions, esp. Preclinical Toxicology/Biological Sciences and Quantitative, Translational and Analytical Sciences (QTAS)/ADME (adsorption, distribution, metabolism and excretion) to ensure key deliverables for asset advancement are met and risks and mitigation plans are in place. Integrates and implements pre-clinical development plans and updates as necessary in collaboration with the global development teams and respective line functions.
• 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 general agency feedback. Responsible for the quality and effectiveness of dossiers and communication with health authorities at global level.