Associate Vice President - Medical Development - Cardiovascular

Indianapolis, IN, United States

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The Diabetes Business Unit at Eli Lilly & Co seeks an experienced and highly motivated physician for the role of Associate Vice President-Medical Development within the cardiovascular platform. This is a highly visible leadership role, contains supervisory and career development responsibilities for direct reports, and requires strong teamwork and coaching skills to facilitate cross-functional communication and decision-making across scientific, regulatory, and commercial stakeholders.

Responsibilities

The Associate Vice President-Medical Development provides leadership, supervision, coordination, mentoring, career development, and performance management for the staff within the cardiovascular phase 3 development team. The Associate Vice President - Medical Development has review responsibilities and approval authority for grants and contracts, protocols and amendments, informed consent documents, expense reports, and other documents related to the work of the therapeutic area group. In addition to his/her management and focused administrative responsibilities, the Associate Vice President - Medical Development drives strategic planning and, with operations teams and management, oversees the clinical research and overall medical support activities of the group. The Associate Vice President - Medical Development 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, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, 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.

Works closely with direct reports, to develop their performance management plans (objectives), development plans, corporate resumes, performance appraisals.

Keeps all performance and career related documents and plans for direct reports up to date.

Helps each direct report's establish mentoring relationships outside the team.

Participates in Succession Planning process identifying high potential talent.

Maximizes each individual direct report's career potential, maximizing the value to the corporation.

Accountable for team's capacity planning and work allocation.

Recognizes and appropriately rewards exceptional performance, talent, and/or contribution.

Ensures that all direct reports are adequately qualified and trained in the tasks they are required to perform.

Oversight of clinical planning, budgeting, and execution

Primary ownership for brand's global medical plan.

Ensures that global clinical plans are coherent and aligned with research unit(s) and business unit.

Ensures medical group meets or exceeds commitments to Development for planned and agreed upon clinical research.

Monitors progress toward implementation of the clinical research plans and takes appropriate steps with the responsible clinical plans personnel and CRPs if progress is not adequate.

Monitors progress toward implementation of other deliverables from the medical team (e.g. affiliate needs, publications, field support) and takes appropriate steps with the responsible cross-functional management team(s) if progress is not adequate.

Works closely with the business unit operations management to monitor operational expenses of the group.

Scientific and Technical Expertise

Maintains his/her deep scientific, technical expertise.

Understands and keeps updated with available internal and external pre-clinical, clinical pharmacological, and clinical data relevant to the team's molecule and therapeutic area.

Provides technical oversight of the design of all clinical research activities, including technical review of all team protocols, trial level safety reviews, and clinical study reports.

Promotes innovation in drug development, study design/methodology, as well as in implementation and shared learning.

Is visibly active in business unit/therapeutic area and maintains credibility with internal and external colleagues and the larger organization, as well as to enhance career satisfaction.

Scientific data dissemination and exchange

Oversight and scientific interpretation of critical data analyses.

Ensures timely dissemination of clinical trial data, including but not limited to manuscripts, abstracts, posters, slide sets, and medical information.

Ownership or lead in development of publication plan/activities.

Oversight of team's attendance and scientific congress support, including ensuring shared learning

Business/customer support (pre and post launch)

Ensures that medical team he/she supports is trained, and compliant with local, global, and company standards with regard to interactions with customers.

Ensures that there is adequate scientific support for marketing and sales activities.

Supports the strategy and/or negotiations for drug reimbursement with national health authorities.

Provides oversight of team's contributions to activities and deliverables of the PRA organization

Regulatory submission responsibilities

Ensures that clinical data generated for regulatory purposes meets all necessary regulatory standards.

Responsible for global registrations, labeling and label modifications, and resolution of regulatory issues.

Overall Administrative Responsibilities

Reviews and approves all major business documents requiring director-level approval. These documents include, but are not limited to research protocols and amendments, research contracts and grants, informed consent documents, label changes, and travel expenses.

Participates in activities which include, but not limited to overall area plans and budgets, strategic planning, support of efforts of other components such as staff recruiting, and participation on various corporate or cross-functional committees.

Ensures that team members respect the highest medical ethical standards of Lilly and of the communities where Lilly does business.

Successful recruiting of clinical research physicians (CRPs) or clinical research scientists (CRSs) for the area

Basic Qualifications

Medical Doctor or Doctor of Osteopathy.

Must be board eligible or certified in appropriate specialty/subspecialty 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. Physicians trained outside the US 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).

Seven years of experience in clinical research/drug development, including the design and implementation of large global clinical trials.

Additional Skills/Preferences

Demonstrated evidence for the capacity to lead and manage groups of professionals

Demonstrated administrative skills, including strong team work skills

Demonstrated evidence of the ability to work within Lilly's governance structure

Demonstrated experience with strong communication, interpersonal, and negotiation skills

Ability to travel away from office, both domestic and international to the degree appropriate to support the business of the team.

Fluent in English, verbal and written communication

Board certified and/or training in Cardiology or Lipidology

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