Overview
Incyte is a global, science-driven biopharmaceutical company recognized for its strong growth and deep commitment to advancing therapies in Hematology, Oncology, and Immunology. With a diverse and expanding early pipeline, Incyte is shaping the next generation of targeted and immune-based therapies. Our strength lies in our ability to combine scientific insight with clinical execution, transforming discoveries into impactful medicines for patients worldwide. We are a company in motion, growing, evolving, and investing in early development as a core engine of innovation. At Incyte, every idea begins with science - and every scientist plays a part in shaping what comes next. We are looking for a Senior Director, Oncology Drug Development to lead the design and execution of clinical development strategies for oncology programs across Phase I-III for Incyte's oncology products. 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-sponsored trials, ensuring alignment with development strategy and scientific rigor.
- Ensures all activities are conducted in compliance with the highest ethical, scientific, and regulatory standards.
Qualifications
- 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.
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