Executive Director, Clinical Development - Hematology Oncology
Incyte
14 days ago
Remote friendly (Wilmington, DE)
United States
Clinical Research and Development
Job Responsibilities:
- Provide medical and scientific leadership to cross-functional teams (clinical development, biostatistics, pharmacokinetics, pharmacovigilance, regulatory, and clinical operations).
- Serve as a key oncology medical expert, guiding strategy, design, and execution of clinical development programs for anti-cancer agents.
- Lead interactions with global regulatory authorities (e.g., FDA, EMA) and contribute clinical components of INDs, NDAs, and other regulatory submissions.
- Oversee development of key clinical/scientific documents (protocols, informed consent forms, CSRs, investigator materials, regulatory documents, publications, and development plans).
- Partner with discovery and translational teams to advance compounds from preclinical into clinical development with strong scientific/mechanistic rationale.
- Collaborate with external partners (CROs, academic institutions, vendors, strategic alliances) to execute global clinical trials.
- Identify, evaluate, and proactively manage clinical/program risks and mitigation strategies.
- Represent the organization at scientific/medical forums (congresses, advisory boards, KOL interactions).
- Partner with Medical Affairs for evidence generation, product launch planning, and lifecycle management.
- Provide medical oversight for investigator-sponsored trials aligned to development strategy and scientific rigor.
- Ensure all activities meet ethical, scientific, and regulatory standards.
Qualifications:
- M.D. or D.O. required; board certification (or eligibility) in Oncology strongly preferred.
- 3–5+ years oncology drug development experience in biopharma or equivalent academic clinical research.
- Demonstrated experience across multiple phases of clinical development.
- Strong knowledge of oncology drug development, clinical trial design, data interpretation, and regulatory requirements.
- Excellent written/verbal communication; ability to present complex scientific information.
- Proven cross-functional effectiveness in a fast-paced, matrixed environment.
- Strong organizational skills; manage multiple priorities and timelines.
- Provide medical and scientific leadership to cross-functional teams (clinical development, biostatistics, pharmacokinetics, pharmacovigilance, regulatory, and clinical operations).
- Serve as a key oncology medical expert, guiding strategy, design, and execution of clinical development programs for anti-cancer agents.
- Lead interactions with global regulatory authorities (e.g., FDA, EMA) and contribute clinical components of INDs, NDAs, and other regulatory submissions.
- Oversee development of key clinical/scientific documents (protocols, informed consent forms, CSRs, investigator materials, regulatory documents, publications, and development plans).
- Partner with discovery and translational teams to advance compounds from preclinical into clinical development with strong scientific/mechanistic rationale.
- Collaborate with external partners (CROs, academic institutions, vendors, strategic alliances) to execute global clinical trials.
- Identify, evaluate, and proactively manage clinical/program risks and mitigation strategies.
- Represent the organization at scientific/medical forums (congresses, advisory boards, KOL interactions).
- Partner with Medical Affairs for evidence generation, product launch planning, and lifecycle management.
- Provide medical oversight for investigator-sponsored trials aligned to development strategy and scientific rigor.
- Ensure all activities meet ethical, scientific, and regulatory standards.
Qualifications:
- M.D. or D.O. required; board certification (or eligibility) in Oncology strongly preferred.
- 3–5+ years oncology drug development experience in biopharma or equivalent academic clinical research.
- Demonstrated experience across multiple phases of clinical development.
- Strong knowledge of oncology drug development, clinical trial design, data interpretation, and regulatory requirements.
- Excellent written/verbal communication; ability to present complex scientific information.
- Proven cross-functional effectiveness in a fast-paced, matrixed environment.
- Strong organizational skills; manage multiple priorities and timelines.