Senior Director, Clinical Development – Prostate Cancer

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $306.8k - $371.8k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Bristol Myers Squibb

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10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Develop and execute clinical development strategy for RayzeBio prostate cancer assets • Lead clinical development plans across the full lifecycle from IND through Phase 3 registrational studies • Grow and manage the prostate cancer clinical team and recruit medical directors and clinical scientists as needed • Work with research and translational medicine teams on clinical-stage assets and pipeline molecules • Participate in business development and due diligence efforts to grow RayzeBio’s portfolio • Engage BMS oncology leaders to develop combination strategies and support prostate disease-area strategies • Provide clinical direction and scientific expertise for early- and late-development molecules • Support IND preparation and regulatory authority interactions • Design and execute Phase 1 to Phase 3 clinical trials and provide medical monitoring • Lead cross-functional study teams through study design, implementation, monitoring, analysis, and reporting • Interact with clinical investigators and thought leaders to design development plans • Partner with investigators and CROs to design and implement clinical studies • Work with GPLs to optimize development and commercialization of RayzeBio assets • Contribute to protocols, investigator brochures, clinical study reports, and regulatory documents • Conduct investigator meetings and lead site qualification and initiation visits • Execute strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets • Translate research and nonclinical findings into clinical development opportunities • Oversee Data Review and Independent Data Monitoring Committees • Ensure clinical trials follow ethical guidelines and applicable pharmaceutical industry standards • Maintain relationships with clinical trial investigators and thought leaders • Lead regulatory interactions, briefing documents, health authority meetings, and regulatory submissions for prostate cancer assets • Supervise and mentor clinical scientists and medical directors • Leverage AI to improve program, portfolio, and functional performance

🎯 Requirements

• MD, PhD, PharmD or equivalent is required • At least 10 years of pharmaceutical, biotech, or academic experience in oncology solid tumor clinical development • Oncology subspecialty training is ideally required/preferred • Radiopharmaceutical experience is preferred but not required • Drug development experience in prostate cancer is preferred but not required • Experience in NDA/MAA preparation and submission • Experience with complex global health authority interactions • Experience in all aspects of early- and late-phase protocol conduct, including protocol writing, study start-up, execution, analysis, and reporting • Experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel • Demonstrated leadership of clinical and cross-functional teams in a biotech environment • Strong written, oral, and presentation skills • Strong critical, strategic, and analytical thinking skills • Skilled in clinical research and pharmaceutical product development and approval processes • Ability to function in a highly regulated environment and follow RayzeBio guidelines and SOPs • Solid understanding of GCP and ICH guidelines • Willingness to travel approximately 30% of the time

🏖️ Benefits

• Additional discretionary incentive cash and stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees • 11 paid company holidays each year • 160 hours of paid vacation annually for eligible new hires • 3 optional holidays for eligible employees • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year, depending on eligibility • Summer hours flexibility, depending on eligibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs • Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees • Reasonable workplace accommodations/adjustments and ongoing support

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