What are the responsibilities and job description for the Sr. Medical Director, Clinical Development position at Bristol-Myers Squibb?
Sr. Medical Director, Clinical Development
Sr. Medical Director, Clinical Development
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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.
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 Senior Medical Director – Clinical Development has responsibility for clinical development of targeted radiopharmaceuticals for treatment of solid tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio’s clinical development plan. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business.
Job Responsibilities :
Essential duties and responsibilities include the following. Other duties may be assigned.
- Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates.
- Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies.
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents.
- Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators.
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
- Translate findings from research and nonclinical studies into clinical development opportunities.
- Oversee Data Review and Independent Data Monitoring Committees.
- Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines.
- Establish and maintain positive relationships with clinical trial investigators and thought leaders.
- Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings.
- Willing to travel approximately 25% of the time. Evening and weekend work will be involved.
Education and Experience :
Skills and Qualifications :
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 $297,878-$403,011 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as 'Transforming patients’ lives through science', every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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