Senior Medical Director, Early Clinical Development
Incyte
Pharmazeutische Industrie
Morges - Schweiz
Abteilungsleiter / Manager
Experteer Overview
In this role you will lead early clinical development for hematology-oncology assets from preclinical nomination to PoC, guiding translational and clinical strategies. You will work with cross-functional teams to shape asset development, regulatory plans, and evidence generation. The role offers exposure to global regulatory interactions and external partnerships to advance candidates toward registrational studies. You will influence study designs, safety/tolerability decisions, and strategic messaging to stakeholders while upholding high ethical and regulatory standards. This is a mission-driven opportunity to drive meaningful progress in cancer therapies at a global biotech leader.
Aufgaben
- Lead development efforts for assets from post-candidate selection through first-in-human trials, including dose escalation, safety evaluation, dose selection, and early translational and proof-of-concept studies
- Contribute to asset/portfolio strategy, prioritization, governance, and cross-functional communication with translational science, clinical pharmacology, pharmacometrics, discovery, and regulatory teams
- Provide medical and scientific guidance to cross-functional teams including discovery, clinical science, biostatistics, PK/PD, pharmacovigilance, and clinical operations
- Support interactions with global regulators (FDA, EMA, PMDA, TGA) and ethics committees; oversee INDs and regulatory documents
- Prepare key development documents (protocols, informed consent, CRFs, CSRs, abstracts, publications, strategy documents, project plans)
- Collaborate with external vendors (CROs, imaging and lab vendors) for early-phase study execution
- Represent Incyte at national/international meetings and advisory boards with key opinion leaders
- Identify and mitigate emergent issues in early clinical development and implement corrective strategies
- Partner with medical affairs and commercial teams to support future agent launches
- Uphold high ethical and regulatory standards; guide investigator-initiated trials and lifecycle management; serve as SME for business development activities
Zentrale Anforderungen
- MD or MD-PhD with hematology-oncology background; board certification preferred
- Experience in early drug development and leading clinical pre-clinical candidate to PoC in humans
- Proficient in English (oral and written)
- Membership in professional societies (e.g., ASH, ASCO, AACR, ESMO) and active engagement in medical education
- Ability to lead sub-teams and drive projects
- Track record in business development and due diligence support
Stellenbeschreibung
In this role you will lead early clinical development for hematology-oncology assets from preclinical nomination to PoC, guiding translation…
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