Executive Director, Clinical Development - Hematology Oncology

Senior Director, Oncology Drug Development Job Responsibilities

• Provides medical and scientific leadership to cross‑functional teams, including clinical development, biostatistics, pharmacokinetics, pharmacovigilance, regulatory, and clinical operations.
• Serves as a key medical expert in oncology, guiding the strategy, design, and execution of clinical development programs for anti‑cancer agents.
• Leads interactions with global regulatory authorities (e.g., FDA, EMA), in close partnership with regulatory colleagues, and contributes to clinical components of INDs, NDAs, and other regulatory submissions.
• Oversees the development of key clinical and scientific documents, including protocols, informed consent forms, clinical study reports (CSRs), investigator materials, regulatory documents, publications, and development plans.
• Partners with discovery and translational teams to advance compounds from preclinical stages into clinical development, ensuring strong scientific and mechanistic rationale.
• Collaborates with external partners, including CROs, academic institutions, vendors, and strategic alliances, to support the successful execution of global clinical trials.
• Identifies, evaluates, and proactively manages clinical and program risks, implementing mitigation strategies to support program success.
• Represents the organization at scientific and medical forums, including congresses, advisory boards, and interactions with key opinion leaders.
• Partners with Medical Affairs to support evidence generation and planning for successful product launches and lifecycle management.
• Provides medical oversight for investigator‑supported trials, ensuring alignment with development strategy and scientific rigor.
• Ensures all activities are conducted in compliance with the highest ethical, scientific, and regulatory standards.

• M.D. or D.O. degree required; board certification (or eligibility) in Oncology strongly preferred.
• Minimum of 3–5 years of oncology drug development experience in the biopharmaceutical industry or equivalent clinical research experience in an academic setting.
• Demonstrated experience contributing to clinical development programs across multiple phases of development.
• Strong understanding of oncology drug development, including clinical trial design, data interpretation, and regulatory requirements.
• Excellent written and verbal communication skills, with the ability to clearly present complex scientific information to diverse audiences.
• Proven ability to work effectively in cross‑functional teams within a fast‑paced, matrixed environment.
• Strong organizational skills with the ability to manage multiple priorities and deliver against timelines.