Remotery

Senior Medical Director, Radiopharmaceutical Imaging

Posted 1 hour ago

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and manage the strategy for the diagnostic imaging portfolio and target product profiles for selected candidates, integrating competitive intelligence and advancing care standards.

• Act as the Clinical Development lead for imaging, delivering medical and scientific guidance across programs and ensuring comprehensive, decision-focused development plans.

• Lead and influence diverse cross-functional teams and external partners (investigators, academic collaborators, CROs, central readers) to design and implement early- and late-phase imaging studies.

• Responsible for the creation of protocol concepts and essential document content, such as protocols, investigator brochures, SAP inputs, clinical study reports, and key regulatory and medical communications.

• Conduct medical monitoring and data review tasks to support clinical studies.

• Provide medical oversight during trial execution, including eligibility assessments, safety reviews, medical monitoring strategies, and escalation pathways in collaboration with Drug Safety/Pharmacovigilance.

• Lead governance for imaging programs, overseeing data review activities and Independent Data Monitoring Committees (IDMCs)/Data Monitoring Committees (DMCs) as necessary.

• Transform findings from research, translational, and nonclinical studies into imaging development opportunities and decision points; synthesize evidence to support go/no-go recommendations.

• Facilitate strategic regulatory engagement as the clinical lead for interactions with health authorities, including briefing package strategy, meeting participation, and advocacy for clinical rationale.

• Build and sustain strong relationships with clinical investigators and key opinion leaders; represent RayzeBio at scientific meetings and advisory boards as required.

• Collaborate closely with CROs and vendors to carry out clinical trials for radiopharmaceutical imaging agents.

• Engage in interactions with health authorities, preparation of briefing documents, HA requests for information, and regulatory submissions.

• Work alongside Medical Affairs and Commercial teams to formulate the evidence-generation strategy and lifecycle plans for radiopharmaceutical imaging within the broader RayzeBio portfolio.

• Assist in resource planning, timeline and budget management, risk mitigation and contingency planning, and vendor oversight to ensure achievement of milestones.

• Utilize AI to enhance program, portfolio, or functional performance through prioritization and extensive adoption.

• Must be willing to travel approximately 30% of the time. Evening and weekend work may be necessary.


⛳️ Requirements

• MD (or equivalent) with over 8 years of experience in the pharmaceutical/biotech sector and/or relevant academic clinical experience, including significant involvement in oncology diagnostic development and/or radiopharmaceutical imaging agent development through regulatory submissions.

• Proven leadership in clinical development with escalating responsibilities, encompassing the leadership of cross-functional teams and steering strategy through critical development decisions.

• Experience in both early- and late-phase protocol development and execution, including study initiation, oversight of conduct, analysis inputs, and reporting.

• Established experience collaborating closely with investigative sites (PIs, sub-investigators, coordinators) and managing external vendors (e.g., CROs, imaging core labs).


🏝️ Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

• Work-life benefits include: Paid Time Off for US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or RayzeBio employees). For Phoenix, AZ, Puerto Rico, and RayzeBio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Based on eligibility*, additional time off for employees may encompass unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

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