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Clinical Research Physician-Med Affairs Loxo

Indianapolis, Indiana

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Req ID R-3503 Title Clinical Research Physician-Med Affairs Loxo City Indianapolis State / Province Indiana Country United States

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Medical Director is delegated various responsibilities by the Sr. Director - Medical or equivalent role to provide leadership, supervision, coordination, coaching, career development, and performance management for all individuals that directly report to them within the business unit, country(ies), or geographic hubs. The position is a developmental role for future management leaders and is intended to provide a balance of management/administrative and technical responsibilities. The position requires a partial transition from a direct CRP/CRS contributor role to managerial/supervisory responsibilities and activities of achieving results through others while supporting the management team in fulfilling corporate goals and initiatives. The Medical Director will support staff within his/her product or therapeutic group. The Medical Director may be delegated such responsibilities as approval authority for grants and contracts, protocols and protocol amendments, label changes, scientific e-disclosure, informed consent documents, travel authorizations, expense reports, and other documents related to the work of the group.

In addition to his/her focused administrative/management responsibilities, the Medical Director participates in strategic planning for and oversight of the clinical research while leading medical affairs activities of the Director's area of responsibility. The Medical Director l will also interact with external consultants and organizations, opinion leaders, and worldwide regulatory agencies, and will provide oversight for responding to medical and regulatory questions and requests related to product.
The Medical Director helps to assure that the group's activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team(s), and Therapeutic Area Program Phase, Early Phase/ Clinical Pharmacology, and Translational Medicine team(s). The Medical Director plays a role in several stages of drug development, with a primary focus on late-phase development, product launch, and commercialization. In the absence of the Sr. Director – Medical (or through delegation), the Medical Director may carry out certain responsibilities of the Sr. Director. The Medical Director maintains the ongoing responsibilities of a Clinical Research Physician for product support and clinical research in his/her area (see area job description for CRP to review job responsibilities), adjusted and balanced to level and extent as appropriate to correspond to the needs of the area and role.

The Medical Director is aware of and ensures that 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, company integrity agreements and the Principles of Medical Research and are aligned with the medical vision.

The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

  • Career Development and Performance Management of direct reports
  • Oversight of clinical planning, budgeting, and execution
  • Oversight of Scientific Disclosure Planning and execution
  • Scientific and Technical Expertise
  • Business customer support (Pre and post launch)
  • Regulatory submission responsibilities
  • Overall Administrative Responsibilities
  • Local Therapeutic Area Responsibilities
  • Recruitment

Company Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Basic Qualifications

  • 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-U.S. 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

Additional Information

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Additional Skills/Preferences

  • Demonstrated understanding of the local area/region's medical marketplace
  • Demonstrated evidence for the capacity to lead and manage groups of professionals with examples of successful leadership and influence
  • Demonstrated experience with strong communication, interpersonal, and negotiation skills
  • Ability to travel away from office
  • Fluent in English, verbal and written communication

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-3503.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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