Associate Medical Director, Microbiome - GI DDU
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Associate Medical Director, Microbiome - GI DDUApply Now
This position requires an acknowledged technical and strategic expert whose primary role is to provide scientific leadership, research planning and decision making in both preclinical and clinical stages of drug development programs in gastrointestinal diseases preferably with experience in microbiome. Responsibilities include partnering with drug discovery scientists and research project teams to identify biomarkers relevant to patients in clinical studies and partnering with Global Product Teams to develop a translational biomarker plan as part of the overall Asset Strategy.
- Collaborate with medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy. Part of the team that provides strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated translational research strategy for assigned program(s).
- Partner with drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response. Participate in the collaborative interactions between Clinical Development and drug discovery researchers at multiple sites to facilitate generation and implementation of clinical development strategies.
- Represent Translational Research on Global Product Teams to contribute to the dose and biomarker selection for first-in-human studies, provide pharmacologic and pharmacodynamic rationales and translational/experimental medicine approaches for clinical protocols.
- Participate in the design and implementation of biomarker research in clinical trials and monitor the scientific quality of pharmacodynamic and predictive biomarker clinical assay data
- Maintain extensive knowledge of the research and development efforts from academic institutions, competitor pharmaceutical companies and fee-for-service bioanalytical companies for relevant GI biomarkers.
- Evaluate, and use new scientific tools and ensure that technical and scientific standards meet state-of-the-art industry expectations.
- Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies.
- Support Medical Affairs and Late Stage development for identifying potential ways that the approved indication can be expanded.
- Support Business Development efforts by evaluating potential in licensing opportunities and serve as a liaison with external companies, organizations, consultants, university representatives, NIH, and with FDA, as required. Establish and maintain scientific dialog with clinical translational experts in medical, academic and regulatory communities.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Ph.D +10 years, or PharmD +12 years, or Masters +13 years or Bachelors +15 years of experience. Degree is expected in relevant scientific area, e.g., GI, Immunology, Pharmacology, Microbiology, Molecular Biology, Cell Biology.
- More than 7 years of relevant industry experience in translational research
- Recognized expertise in biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations
- Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of translational research strategies implemented in early clinical programs in a timely manner
- An understanding of Proof-of-Concept and Proof-of-Mechanism clinical concepts and trial design
- Should serve as a “highly credible technical expert” to outside functional areas
- Excellent understanding of drug development, regulatory processes and clinical development
- Strong leadership abilities and proven ability to lead a team within a matrix organization as well as work independently
- Superior analytical, problem solving skills
- Extraordinary oral and written communication skills
- Exceptional interpersonal skills
- 25% National and International travel.
Job ID R0012330