Executive Director, Clinical Development - Hematology Oncology

Incyte Corp

  • Wilmington, DE
  • 30+ days ago

    Highlights

    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 Incytes oncology products. 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.

    Numbers & Facts

    LocationWilmington, DE

    Description

    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 Incytes 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. LI-MB1

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