Job Summary

The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials.

Position Summary / Objective

• Serves as a primary source of medical accountability and oversight for one or more clinical trials
• Matrix management responsibilities across the internal and external network
• Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities
• Provides medical and scientific expertise to cross-functional colleagues

Job Description

Responsibilities

Medical Monitoring

• Provides medical input on study and country feasibility, including site feasibility assessments
• Contributes to eCRF design, UAT, and CRF Completion Guidelines as needed
• Conducts ongoing clinical data review and assesses protocol deviations
• Addresses medical queries from sites/IRBs, including eligibility, safety, dose modifications, and adverse event management
• Serves as study medical expert and oversees CRO Medical Monitor activities, including data review and medical guidance (e.g., AE coding)

Clinical Development Expertise & Strategy

• Leads development and execution of the Clinical Development Plan (CDP), ensuring alignment with protocols and Target Product Profile (TPP)
• Provides medical/scientific leadership for study design, protocol development, and key study-level documents (e.g., CSR, IB, regulatory responses)
• Interprets and presents clinical data to internal and external stakeholders; supports regulatory and safety reporting (e.g., DSUR, PSUR)
• Delivers scientific training and leads key study meetings (e.g., IM, SIV) on compound, disease, and safety management
• Maintains deep therapeutic area expertise and contributes to strategic insights on disease landscape, competition, and product positioning (TPP/EPP)
• Leads engagement with governance bodies (e.g., DMC, Steering Committee), including charter development, presentations, and ongoing oversight
• Oversees external partnerships (e.g., CROs, AROs, cooperative groups) and contributes to labeling and product lifecycle management

Health Authority Interactions & Publications

• May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections
• May support the GCL, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations.
• Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings

Qualifications

Education Qualifications

• MD required
• Postgraduate training in TA or related specialty required

Experience Qualifications

• 7+ years relevant clinical experience required
• Experience in Hematology preferred.

Travel Requirements
Ability to travel up to 20% of the time.