Job Details

Director, Medical Affairs Research Operations

Director, Medical Affairs Research Operations

Apply locations San Diego - RayzeBio - CA time type Full time posted on Posted 16 Days Ago job requisition id R1589522

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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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).

Skills and Qualifications:

• Excellent and effective interpersonal and communication skills.
• Must be well organized and able to multi-task in a fast-paced deadline driven environment.
• Prior experience interpreting and implementing regulations and guidelines governing clinical trials.
• Advanced computer and Internet skills, including knowledge of MS applications (such as Word, PowerPoint, Teams, Excel), Veeva, electronic publication management tools, SharePoint, references databases, PubMed, etc.
• Knowledge of information technology systems supporting medical affairs activities.

Physical Demands:

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment:

• The noise level in the work environment is usually moderate.

The starting compensation for this job is a range from $194,000 - $266,000 plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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