Director, Medical Affairs Research Operations

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RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Director, Medical Affairs Research Operations, plays an integral role in supporting the Medical Affairs team. This position provides operational and scientific support of investigator-initiated trials, to ensure their successful implementation. This individual is responsible for activities associated with activation, tracking, and reporting of study-related information. This role will work cross-functionally with several departments (Clinical Operations, CMC, Regulatory Affairs, Supply Chain, Drug Safety/PV, Compliance and Legal).

Responsibilities:

Essential duties and responsibilities include the following.  Other duties may be assigned.

• Provide operational expertise and lead the Investigator Initiated Trial (IIT) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements

• Conduct budget negotiations for Medical Affairs IITs, including fair market value assessments for all study related items. Create process for internal review of budgeting of trials

• Maintain all internal records and databases associated with IIT program and develop reports when required

• Create departmental SOPs and maintain these documents over time. Conduct training for cross-functional partners on appropriate processes

• Ensure that processes allow for activation of studies in a timely fashion consistent with the developed SOPs. Assist in activation workflow to ensure all study timelines are met

• Create IIT strategy with cross functional team members both within medical affairs as well as clinical development, clinical operations, regulatory, legal, etc

• Collaborate with operations to ensure drug shipments, milestones, etc. are aligned to study specific timelines

• Work with regulatory affairs to ensure that all investigator-initiated trials adhere to relevant regulatory guidelines, including IRB approvals and IND submissions

• Maintain safety data from all trials to ensure patient safety and necessary documentation for any regulatory needs

• Assess all IIT invoicing and perform budget reconciliation upon any changes within IIT protocols

• Assist with other duties related to the operations of the IST program, including facilitation and management of cross-functional work-streams

• Ability to travel (US and International) approximately 25% of time

Education and Experience:

• Advanced degree (PhD, Pharm D, MD, DO, Advanced Nursing Degree, Advanced Degree in Health Sciences, MS, or equivalent) with 5+ yrs experience in leading an Investigator initiated trial (IIT) program in a pharmaceutical environment

• Oncology experience required (GI oncology and radiopharmaceutical experience strongly preferred).

• Demonstrated strong project management skills and leadership poise a must to negotiate and facilitate alignment amongst internal and external stakeholders (KOLs, internal cross-functional teams).