Director - Medical - Clinical Research Physician

Basic Qualifications/Requirements

• 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. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. 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

• Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision. Support preparation of high-level plan for phase Ill studies.
• Collaborate with local clinical research staff, consultants and clinical investigators in the design, conduct and reporting of global Phase lb and Ila/IIb clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
• Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug­ disease response models.
• Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
• Collaborate with non-clinical pharmacologists to translate observations from animal experiments to human clinical studies (biomarker development) in the area therapeutic area of responsibility.
• Collaborate with drug disposition scientist to conduct pharmacokinetic and drug metabolism studies of drug candidates in humans.
• Assist pharmacokineticists and statisticians by providing clinical support to the development of pharmacostatistical models of drug exposure and response (PK/PD modeling and trial stimulation) to optimize dosing regimens and selection of the target patient population.

• Design and oversee implementation of Phase lb and Ila/IIb clinical studies.
• Design and write clinical trial protocols.
• Design and oversee implementation methods for development and biomarker qualification studies.
• Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
• Participate in investigator identification and selection, in conjunction with clinical team.
• Interact with consultants and clinical investigators to plan, initiate, and conduct worldwide clinical trials (Phase I and II).
• Review and approve risk profiles, and local informed consent documents as required, to ensure appropriate communication of risk to study subjects.
• Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
• Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Serve as resource to CDAs I clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
• Understand and actively address the scientific information needs of all investigators and personnel.
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.

• Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
• Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
• Participate in reporting of clinical trial data in Clinical Trial Registry activities.
• Consider, review or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
• Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
• Participate in data analysis, development of scientific data dissemination and preparation of final reports.
• Support development of slide sets and publications (abstracts, posters, manuscripts).
• Support the creation and review of any scientific information with respect to customer questions or media request in accordance with global compliance policies and procedures.
• Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).

• Support/ assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.
• Develop and review labeling modifications in collaboration with regulatory and safety groups.
• Participate in risk management planning along with GPS colleagues.
• Provide medical expertise to regulatory scientists.

• Understand the scientific/medical needs of all CMR Program Phase customers (payers, patients, health care providers
• Provide advice and consultation to global business unit with regard to potential markets for development compounds and in-licensed projects or compounds.
• Support business development in collaboration with the regulatory and corporate affairs group.
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis.
• Participate in PhRMA or other local or national trade associations.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Participate in patent development.
• Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert.

• Critically read and evaluate the relevant medical literature; know the status and data in medical field of interest; and keep updated with medical and other scientific developments relevant to the therapeutic area.
• Provide consultation to health outcomes staff, marketing professionals, and management regarding the potential medical need served by responsible therapeutic area drug candidates.
• Knowledge of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the development projects.
• Explore and take advantage of opportunities for extramural scientific experiences.
• Attend scientific symposia.
• Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule.
• Maintain awareness of current clinical practices through experience or contacts.