Senior Medical Advisor

Through application of scientific training, clinical expertise, and relevant experience, the Diabetes Research Design Hub Clinical Research Physician (CRP) participates in: the development of corporate/global clinical trials in support of registration and commercialization of the product; the review process for protocols and publications; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.

The Clinical Research Physician must have deep understanding of diabetes, physiology and clinical study design and research. He/She must also be aware of novel ideas, be willing to interact and learn from different teams, including different therapeutic areas. He/She must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidances (e.g. FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and Principles of Medical Research.

Core Job Responsibilities

The primary responsibilities of the Diabetes Research Design Hub CRP are generally related to diabetes phase I to IV compounds. The core job responsibilities include those listed below as well as all other duties as assigned.

Clinical Planning

• Collaborate with the Diabetes Business Unit Development Team, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and design of study protocols which address key needs (registration, patient, provider, and payer); the product lifecycle plan, clinical strategies.
• Contribute to business unit and global alignment of clinical strategy and plans.
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
• Work closely with clinical operations, regulatory and safety in order to better design studies and programs which address the aforementioned goals.

Clinical Research/Trial Execution and Support

• Collaborate with clinical research staff in the design, and conduct, of clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
• Review risk profiles to ensure appropriate communication of risk to study subjects.
• Participate in investigator identification and selection, in conjunction with Design Hub and clinical teams.

Scientific Data Dissemination/Exchange

• Knowledge of, and compliance with, local laws, regulations, global policies and procedures, and compliance guidelines with respect to data dissemination and interactions with external health care professionals.
• Support of advisory board meetings, and other meetings with health care professionals.
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.

Regulatory Support Activities

• Provide medical expertise to regulatory scientists.
• Participate in advisory committees.
• Participate in risk management planning along Development Colleagues and Global Patient Safety (GPS).

Business/ customer support (pre and post launch support)

• Become familiar with market archetypes and potential influence on the medical interventions for the product.
• Participate in PhRMA or other local or national trade associations.

Scientific / Technical Expertise and continued development

• Critically read and evaluate the relevant medical literature; and keep updated with medical and other scientific developments relevant to the product.
• Be aware of current trends and projections for clinical research, and practice, and access in the therapeutic area(s) relevant to the product.
• Explore and take advantage of opportunities for extramural scientific experiences.
• Attend scientific symposia.

General Responsibilities

• Support the management team, including the Sr. Medical Director
• 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.
• Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
• Model the leadership behaviors.
• Be an ambassador for the Lilly Brand.

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.

#WeAreLilly

Basic Qualifications

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in preferably Endocrinology, Diabetes and/or Metabolism 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
• Clinical research or pharmaceutical medicine experience in diabetes.

Additional Information

Primary internal interactions

• Director(s)-Clinical Operations, managers or project managers
• Clinical planning, operations, CRPs/Ss, other research staff
• Statisticians
• Scientific communication associates
• Health outcomes research consultants/research scientists
• Regulatory directors, scientists, and associates
• Product directors, managers, and associates of the brand teams
• Legal counsel
• Therapeutic area physicians, development CRP/Ss, medical affairs CRP/Ss, early phase physicians, and Sr. Director-Medicals
• Global Marketing director or manager
• Corporate patient safety physician

External Contacts

• Scientific and clinical experts, thought leaders
• Lilly clinical investigators
• Practicing physicians/prescribers
• Regulatory agency personnel
• Professional association staff and leaders
• Disease advocates and lay organizations focused on relevant health issues

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

• Knowledge of drug development process preferred.
• Fluent in English; both written and verbal communications.
• Interpersonal, organizational and negotiation skills.
• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Excellent teamwork skills.
• Willing to relocate to Indianapolis.
• Willing to engage in limited domestic and international travel to the degree appropriate to support the business.