Program Medical Leader/Head, TM and Early Clinical Development (MD or PhD) ; Oncology Biotech ; Boston area: RETAINED SEARCH
This is a newly created senior-leadership role reporting to the CMO. As Head of Translational Medicine and Early Clinical Development, you will be responsible for establishing and leading the function from the ground up.
Our client is a Company that offers the “best of both worlds,” i.e. working for a very well financed Company that maintains an agile “start-up” culture: makes quick decisions and fosters a collegial environment. Furthermore, our client has historically offered very strong and favorable compensation/relocation packages to attract top talent.
Location: Boston/Cambridge area
The Head of Translational Medicine and Early Clinical Development will develop and execute translational medicine and early clinical development strategy to effectively bridge pre-clinical and early clinical phases to improve overall success/speed of portfolio assets. This person will lead the Translational Medicine effort of the Company’s oncology compounds from pre-clinical (pre-IND) studies to the Proof-of-Concept (PoC) phase.
- Develop, implement and manage the Company’s Translational Medicine & Early Clinical Development strategy. In collaboration with internal and external R&D partners, lead the Translational Medicine effort of the Company’s oncology compounds from pre-IND studies to the proof-of-concept (PoC) phase.
- Responsible for the Integrated Development Plan (IDP) through PoC in partnership with other functional areas. This includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, acquisition of clinical samples and other relevant activities.
- In close collaboration with research scientists (internal and external), identify, develop, and implement strategy for preclinical support of program-related objectives.
- Develops the First in Human (FIH) and PoC strategy including projects and, for example: makes recommendations regarding endpoints, design, safety evaluations, and initial dose selections
- Lead global project teams through PoC phase to drive implementation of the PoC strategy by providing medical and scientific leadership and expertise to all line functions on the project team.
- Accountable for compound related biomarker strategies; works closely with Biomarker experts in implementation. Guide teams to align preclinical and clinical biomarker strategies.
- Responsible for implementation of additional supporting studies during the research and PoC phases, which may include methodology studies to identify and validate novel endpoints for early decision making in PoC studies and identify endpoints by which patient populations can be stratified to optimize chances of detecting signs of activity of candidate molecules in early clinical studies.
- Assures overall quality of appropriate aspects of Clinical Plan, Study Synopses, Study Protocols, and Clinical Trial Reports (CTRs) and Summaries (e.g. slide format and executive summaries).
- Participate in team presentations to health authorities including IND, and Clinical Trial Authorization (CTA) IB, annual safety report, etc. Participates in analysis of study results and presents conclusions to relevant decision boards.
- Acts as the primary Company representative to Health Authorities (HA) and invite appropriate experts (internal and external) together with focus on early development.
- Facilitate the establishment and maintenance of effective collaborations with academic institutions and patient foundations.
- Develop and manage yearly budget for the department and ensure appropriate alignment to agreed portfolio. Participate and represent area of expertise in the Company’s mid-term Business Planning process.
- Liaise effectively with parent company and other internal stakeholder groups/personnel to advance the Company’s R&D pipeline and promote a highly collaborative operating culture.
- MD degree or a PhD degree, with progressive experience in oncology translational medicine/ biology, pharmacology or directly related discipline, preferably in the biopharmaceutical/biotech industry or academia.
- Proven experience leading oncology/hematology compounds from pre-clinical (pre-IND) studies all the way through to Proof-of-Concept (PoC) phase, including developing, implementing, and managing the translational medicine and early clinical development strategy.
- Broad knowledge of Oncology and excellent scientific knowledge in Translational Medicine, Pharmacogenetics, and Clinical Pharmacology within the oncology field is highly desirable.
- Highly developed mastery of the planning, control and monitoring of complex and highly visible drug development projects and activities with solid experience in pharmacology and translational medicine within the pharmaceutical industry.
- Demonstrated scientific and business acumen and the ability to influence senior leaders and stakeholders and lead complex partnership and alliance activities.
- Record of successful support of multiple, complex, global translational medicine clinical projects and related deliverables.
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