The Head of Translational Medicine and Early Development will develop and execute translational medicine and early development strategy to effectively bridge preclinical and early clinical phases to improve overall success/speed of portfolio assets.
- Develop, implement and manage the Company’s translational Medicine & Early 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 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.
- Contribute to evaluation of clinical centers and foster communication with crucial collaborating investigators in collaboration with Clinical Operations.
- 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.
- Participates in analysis of study results and presents conclusions to relevant decision boards.
- 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.
- 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.
- Perform other duties as directed.
- MD or MD/PhD with at least 10 -15 years progressive experience in oncology translational medicine/biology, pharmacology or directly related discipline, preferably in the biopharmaceutical/biotech industry.
- Highly developed mastery of the planning, control and monitoring of complex and highly visible drug development projects and activities with a minimum of ten years- 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.
- Ability to provide motivational leadership to the organization and improve its performance through the adoption of novel approaches to advancement of clinical assets.
- Broad knowledge of oncology and experience is highly desirable.
- Proven record of scientific achievement as evidenced by presentations and publications in peer reviewed journals.
- Excellent scientific knowledge in Translational Medicine, Pharmacogenetics and Clinical Pharmacology within the oncology field.
- Position requires approximately 10% travel.
Job Location: Cambridge, MA
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Equal Opportunity Employer
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