About the position
The VP/Head of Translational Medicine and Early Clinical Development will be instrumental in supporting the growth of the organization as it continues to build the value of its current products and develop new products. The candidate will develop and execute translational medicine and early 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.
Essential Duties and Responsibilities
- 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 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 the medical need, design of the clinical development pathways, and review of pre-clinical data for clinical implications, acquisition of clinical samples and other relevant activities.
- Reviews medical narratives and ensures that the narratives meet an acceptable medical standard in the Clinical Study Report (CSR).
- 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 and makes recommendations regarding study endpoints, design, safety evaluations, and initial dose selections. 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.
- Acts as the primary Company representative for communication with Health Authorities (HA) and invites appropriate experts (internal and external) together with a focus on early development of clinical candidates.
- Facilitates the establishment and maintenance of effective collaborations with academic institutions and patient foundations.
- Develops and manages a yearly budget for the department and ensures appropriate alignment with all of the clinical candidates in the company pipeline. Participates and represents the expertise in the development of clinical candidates in the Company’s mid-term Business Planning process.
- Provides consistent replies across the countries (US and China) regarding the trial both to IRBs and health authorities.
- Supports the participating countries in their needs of medical knowledge, e.g. through training/presentations to top KOLs etc. Helps and guides medical professionals in countries participating in the development of clinical candidates.
Education and Experience
- MD degree or a PhD degree, with10+ years progressive experience in oncology, translational medicine/biology, pharmacology or directly related discipline, preferably in the biopharmaceutical/biotech industry. Immunology experience a plus
- Proven experience leading oncology/hematology compounds from pre-clinical (pre-IND) studies all the way through to the Proof-of-Concept (PoC) phase, including developing, implementing, and managing the translational medicine and early 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 5+ 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.
- Familiar with the regulatory and legal environment, working knowledge of ICH GCP guidelines.
- Bilingual in English and Chinese a plus.
- Up to 20% international travel