Clinical Trial Physician

About the role

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

Responsibilities

• Medical Monitoring
  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
  Serves 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
  Participates and contributes 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.
  Liaises 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
• Health Authority Interactions & Publications
  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

Requirements

• MD required (or ex-US equivalent)
• 3 or more years of Industry experience and/or equivalent clinical trials experience is required

Key Competency Requirements

• Ability to communicate and present information clearly in scientific and clinical settings
• Board certification or eligibility in medical oncology or related field is desired
• 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
• Leverage AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

Qualifications

• Experience in clinical trials

Skills

• Strong leadership skills
• 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
• Leverage AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

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.
• 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

Pay

$210,572 - $255,164 in Princeton - NJ - US
$227,418 - $275,577 in San Diego - CA - US

Schedule

Domestic and International travel may be required up to 15%.