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Fusion Pharmaceuticals · 1 week ago

Director, CMC Project Leadership

Boston, MA

Full-time

Hybrid

Director/Executive

$163K/yr - $244K/yr

10+ years exp

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radioconjugates as precision medicines. The Director, CMC Project Leadership will lead CMC efforts for the lead asset, FPI-2265, and represent CMC on the Global Program team, ensuring effective development and commercialization of new medicines.

BiopharmaBiotechnologyMedicalOncologyPharmaceutical

Hiring Manager

Steve Downing

Responsibilities

Has overall accountabilìty for defining and delivering the pharmaceutical development strategy that delivers effective development, approval, commercialization and LCM of new medicines

The key CMC accountabilities include

1. The overall development and technical strategy

2. The regulatory strategy and documentation for marketing authorizations (incl IND/IMPD)

3. For in-market products, the role holder is accountable for the development and delivery of the Manufacturability Strategy & Plan

4. Clinical supply chain strategy and plan for Phase 3 (transferred generally at start of Phase 3)

Accountable to the Global Program Team (GPT) for maintaining and delivering all aspects of the pharmaceutical development plan including control of the scope, timing, resources, cost, quality and risk

An active member of the GPT, contributing to the development of overall project strategies. Is expected to have credibility and influence within the team in which the role holder is a member

Accountable for the technical development strategy for APl, DP & Analytical aligned with project strategy and priority

The role involves a diverse range of problems/opportunities requiring complex judgements and solutions based on highly developed levels of conceptual thought and strategic vision and analysis

May represent CMC on the evaluation of business development opportunities

Has the responsibility to ensure that project strategies are reviewed

Qualification

CMC leadershipPharmaceutical strategyProject managementRegulatory strategyNegotiation skillsInterpersonal skillsCoaching skillsLearning agilityTeam leadershipCommunication skills

Required

10+ years experience in product development and manufacturing

Demonstrated strong leadership with enterprise mindset, learning agility, networking and negotiation skills and collaborative approach supportive of delivery of business objectives

Demonstrated strong interpersonal and communication skills with ability to set clear direction and objectives for the team and to influence at a senior level in the organization including Governance groups

Capable of managing the responsibilities for a diverse range of activities and projects acting as the key sponsor for projects and programs supporting their project portfolio

Excellent negotiation and influencing skills in order to influence and contribute to the cross-functional project/product strategies and deliverables

Possess strength and independence of viewpoint and be willing to challenge others in senior roles in other parts of Global Operations and the rest of the business when appropriate

Ability to develop & implement end-to-end Pharmaceutical strategy across all CMC areas (APl, DP, etc.) aligned with the overall GPT strategy and clinical/commercial supply

Significant experience of leading multi-disciplinary teams with an ability to ensure correct structure and team composition for efficient delivery and transition across the value stream

Strong coaching and motivational leadership skills that support the development of and delivery through the Pharmaceutical Team

Preferred

Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline

PMP certification