Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (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 Phase 2 trials; 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 radioconjugate 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.

The VP, Clinical Development will report to the VP, Clinical Lead and be responsible for assisting with the advancement of the aforementioned program(s) by overseeing clinical development activities and by serving as a representative for Clinical to project specific Global Development Teams. In addition, the VP, clinica serves as the Medical Monitor for ongoing clinical trials in assigned trials, ensuring compliance with ICH/GCP and federal regulations. The right candidate will also be responsible for providing leadership and mentoring and oversight of direct reports in addition to assisting in building out a development group/functions.

Responsibilities: 

• Lead and provide strategic oversight for clinical development plans, including protocol development, trial design, and execution to support global regulatory submissions and commercialization strategies.
• Collaborate closely with Clinical Operations and CROs to ensure high-quality, timely, and cost-effective execution of clinical trials, while adhering to regulatory requirements and corporate objectives.
• Work alongside Medical Monitor(s) in collaboration with clinical science to oversee patient safety and assess emerging clinical data.
• Review clinical trial protocols, informed consent forms, case report forms (CRFs), clinical study reports (CSRs), and regulatory submissions, ensuring scientific rigor and regulatory compliance.
• Collaborate with internal teams (e.g., Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Pharmacology) to interpret study data, prepare clinical data presentations, and support regulatory meetings and submissions.
• Lead the preparation and presentation of clinical data at internal and external meetings, including investigator meetings, advisory boards, and major scientific conferences.
• Collaborate with the VP, Clinical Lead to ensure strategic alignment of clinical programs, facilitate decision-making, and integrate clinical development plans with overarching corporate goals.
• Oversee, mentor, and develop clinical staff, fostering a culture of continuous learning, collaboration, and professional growth.
• Escalate significant clinical, operational, or strategic concerns to the VP, Clinical Lead in a timely and transparent manner to facilitate resolution and maintain program integrity.
• Monitor and analyze competitive intelligence to ensure awareness of industry trends, competitor activities, and potential implications for clinical programs.

Requirements: 

• 7-10 years of hands on pharmaceutical or biotech experience in clinical development within Oncology
• MD Hematologist/Oncologist or Radiation Oncologist preferred
• Experience leading oncology early clinical development programs and working with discovery, preclinical, translational and external collaborators
• In depth knowledge of drug development process and oversight of clinical trials
• Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
• Prior interaction with Regulatory authorities and rafting regulatory related documents
• Prior participation and experience in performing due diligence exercises
• Prior experience developing radiopharmaceuticals and/or antibody drug conjugates is a plus
• Excellent interpersonal, written, verbal and visual communication skills
• Proven ability to successfully manage multiple tasks and prioritize accordingly
• Professional and pleasant demeanor
• Willingness to travel as needed

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.