ResponsibilitiesDo you have expertise in ClinicalPharmacology? Have you hadexperience leading early phase exploratory and late phase biopharm submission studies? Doescollaborating with scientific partners to develop clinical pharmacology submissions excite you? Through the application of scientific and medical training, clinical expertise and relevant clinicalexperience, the ClinicalPharmacology Clinical ResearchPhysician or ClinicalResearch Scientist (CRP or CRS) will beresponsible for the Clinical Planning, Clinical Research/Trial Execution Support, Scientific Dissemination/Exchange, Regulatory Support activities, Business Customersupport (pre and post launchsupport) as well as the following:
- Develop, conduct and the reporting of global clinical trials for new compounds
- Implement global clinical trials
- Report adverse events as mandated by corporate patient safety
- Review process for protocols, studies reports, publications and data dissemination for products, new and updated labels
- Lead grant submissions and contracts, contacts with regulatory and other governmental agencies
- Own outreach activities aimed at the external clinical customer community, including thought leaders.
- Collaborate with research scientists to identify lead compounds and plan pre-clinical studies as well as network with the Business Unit to plan for the clinical pharmacology submission package.
- Serve as a scientific resource for study teams, departments, and others as needed
- Ensures all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision.
- Support the management team, including the medical director, in preparation and administration of the Clinical Pharmacologybudget
- Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers
- Actively participate in recruitment, diversity and retention efforts
- Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management
- Support Due Diligence activities as requested
- Model the leadership behaviors outlined in the 'On Leadership' White Paper
- Be an ambassador of both patients and the Lilly Brand
- Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Foreign medical graduates who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
- Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
- Strong preference for 3+ years of clinical experience or pharmaceutical industry experience
- Oncology, Immunology, or Translational Medicine experience strongly preferred
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
- Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
- Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
- Fluent in English, verbal and written communication