Director, CMC

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radio conjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial;

FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR‑cMET targeted radio conjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune‑oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state‑of‑the‑art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.

Fusion Pharmaceuticals is opening a role for a Director, CMC Project Leadership. Reporting to the Vice President of Manufacturing, this individual will be responsible for leading CMC efforts for our lead asset, FPI-2265 and representing CMC on the Global Program team.

This high visibility position requires excellent communication skills, multi‑tasking ability, and desire to strive in a fast‑paced environment. The successful candidate will bring a strong background in CMC and Project leadership.

This position is based out of our Boston, MA office and will follow a hybrid work schedule.

• 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:
  • The overall development and technical strategy
  • The regulatory strategy and documentation for marketing authorizations (incl IND/IMPD)
  • For in-market products, the role holder is accountable for the development and delivery of the Manufacturability Strategy & Plan.
  • 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.

• 10+ years experience in product development and manufacturing;
  Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline preferred. PMP certification a plus.
• 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…