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Executive director, clinical development - hematology oncology

Morges
Incyte
Inserat online seit: 10 Juni
Beschreibung

Ph3Senior Director, Oncology Drug Development /h3 h3Job Responsibilities /h3 ul liProvides medical and scientific leadership to cross‑functional teams, including clinical development, biostatistics, pharmacokinetics, pharmacovigilance, regulatory, and clinical operations. /li liServes as a key medical expert in oncology, guiding the strategy, design, and execution of clinical development programs for anti‑cancer agents. /li liLeads 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. /li liOversees 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. /li liPartners with discovery and translational teams to advance compounds from preclinical stages into clinical development, ensuring strong scientific and mechanistic rationale. /li liCollaborates with external partners, including CROs, academic institutions, vendors, and strategic alliances, to support the successful execution of global clinical trials. /li liIdentifies, evaluates, and proactively manages clinical and program risks, implementing mitigation strategies to support program success. /li liRepresents the organization at scientific and medical forums, including congresses, advisory boards, and interactions with key opinion leaders. /li liPartners with Medical Affairs to support evidence generation and planning for successful product launches and lifecycle management. /li liProvides medical oversight for investigator‑supported trials, ensuring alignment with development strategy and scientific rigor. /li liEnsures all activities are conducted in compliance with the highest ethical, scientific, and regulatory standards. /li /ul h3Qualifications /h3 ul liM.D. or D.O. degree required; board certification (or eligibility) in Oncology strongly preferred. /li liMinimum of 3–5 years of oncology drug development experience in the biopharmaceutical industry or equivalent clinical research experience in an academic setting. /li liDemonstrated experience contributing to clinical development programs across multiple phases of development. /li liStrong understanding of oncology drug development, including clinical trial design, data interpretation, and regulatory requirements. /li liExcellent written and verbal communication skills, with the ability to clearly present complex scientific information to diverse audiences. /li liProven ability to work effectively in cross‑functional teams within a fast‑paced, matrixed environment. /li liStrong organizational skills with the ability to manage multiple priorities and deliver against timelines. /li /ul /p #J-18808-Ljbffr

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