Clinical Trial Physician

Bristol Myers Squibb • San Diego, CA

6h • Hybrid

About The Position

The RayzeBio Clinical Trial Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of radiopharmaceutical drug development. Clinical Development drives strategy, design, execution, and interpretation of clinical trials. Position Summary / Objective Serves as a primary source of medical accountability and oversight for clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 – Phase 4 studies, with demonstrated decision making capabilities Provides medical and scientific expertise to cross-functional BMS colleagues

Requirements

• MD required (or ex-US equivalent)
• 3 or more years of Industry experience and/or equivalent clinical trials experience is required
• Ability to communicate and present information clearly in scientific and clinical settings
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Knowledge of drug development process and ICH-GCP guidelines
• Knowledge of the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment
• Ability to leverage AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

Nice To Haves

• Board certification or eligibility in medical oncology or related field is desired

Responsibilities

• Contributes to and is a key member of a high performing Study Execution Team
• Conducts medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) and Clinical Development Lead (CDL) for medical questions and education (including safety management guidelines in collaboration with Pharmacovigilance)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Pharmacovigilance and oversees safety narratives, identification of safety signals and trends based on aggregate safety analyses
• Serve as 24-hour emergency medical contact (on rotational basis) and responsible for providing responses to medical queries from investigational sites, CRO teams and other study personnel
• Participate and contribute to study safety committee meetings such as Safety Review Committees (SRC), Data Review Committees (DRC) and/or Data Safety Monitoring Boards (DSMBs)
• Collaborates with CS/CDL and inputs into protocols, providing medical strategic oversight in protocol development (e.g. input on inclusion/exclusion, endpoints and assessments, dose modification guidelines and other safety-related clinical considerations), drafting/editing Medical Monitoring Plan (MMP) and Medical Data Review Plan (MDRP) documents.
• Liaise with CRO Medical Monitor (where applicable) to align on workflows, guidance to investigators, among others
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• Responsible for training internal and external team members in clinical protocol and related study-specific materials, product-specific training, including Investigator Meetings and Site Initiation Visits (SIVs)
• Provide medical input for Regulatory Authority responses, IRB/EC submissions, and Health Authority interactions
• Maintains regular communication with CDL and cross-functional team
• Identifies opportunities for streamlining MM workflows and works with appropriate parties to execute related initiatives
• In collaboration with the CDL, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for one or more studies
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with CS
• Partners with CS/CDL to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Identifies and builds relationships with principal investigators.
• Supports identification and cultivation of thought leaders to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
• Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with CS/CDL to allow for protocol-specific training, supporting the study team, investigators, and others
• Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
• Authors/drafts/edits clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CS/CDL

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• Paid Time Off 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)
• 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 include 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 Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree