Associate Vice President – Cardiovascular - Cardiometabolic Health Global Medical Affairs

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Purpose:

The Associate Vice President (AVP) – Cardiometabolic Health Global Medical Affairs drives strategic planning and, through clinical plans managers, team leaders, and close collaboration with the other functional teams, within the area, oversees the clinical research and overall medical support activities of the group. He/she provides leadership, supervision, coordination, mentoring, career development, and performance management for all activities and individuals that directly report to them within the business unit, country(ies) or geographic hubs. The AVP has review responsibilities and approval authority for grants and contracts, post registration trials and amendments, informed consent documents, travel authorizations, expense reports, and other documents related to the work of the therapeutic area group. He/she may delegate some of his/her duties to a Senior Director - Medical. In addition, he/she is responsible for assuring that the group's activities are clearly aligned with the strategic priorities of the Cardiometabolic Health Global Medical Affairs team(s), brand team(s), and global Development team(s), and Therapeutic Area Program Phase, Early Phase I Clinical Pharmacology, and Translational Medicine team(s). In this role, the AVP maintains open, collaborative contact and relationships with global and affiliate Medical Affairs, partnerships or collaborations, global Development team(s), and marketing management and staff.

The AVP 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.

Primary Responsibilities:This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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

1. Career Development and Performance Management of direct reports

•Works closely with direct reports to develop their performance management plans (objectives) and development plans, and documentation of their expertise.•Keeps all performance and career related documents and plans for direct reports up to date.•Meets regularly with each direct report to coach, mentor, evaluate progress toward objective fulfillment, evaluate training and development needs, and monitor career development goals.•Maximizes each individual direct report's career potential, maximizing the value to the organization.•Accountable for CRP/S and other reports capacity planning and work allocation.•Responsible for retaining talented people for the long term.•Responsible for presenting the activities, desires, capabilities, and achievements of direct reports to the business unit medical management and leaders, HR, and Global Medical Organization and Development department for talent assessment, performance evaluation, and timely promotion consideration.•Participates in succession planning for the area.Recognizes and appropriately rewards exceptional performance, talent, and/or contribution.•Ensures that CRP/Ss, other direct reports are adequately qualified and trained in the tasks they are required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self and direct reports.

2. Oversight of clinical planning, budgeting, and execution

•Responsible for affiliate evaluation and input into clinical planning and contribution to clinical trials and communicates research needs to global Development team, Health Outcomes and Pricing, Reimbursement & Access (PRA) teams to ensure registration and post-registration clinical programs meet the needs of local/regional customers.•Responsible for the local/regional clinical planning process for each brand team associated with the business unit/therapeutic area, to assure that plans are appropriately aligned with and support brand, affiliate, business unit, and company strategies and are completed on time for the annual business planning process.•Ensures that local/regional clinical plans are coherent and not in conflict with those of Early Phase and global Development team(s).•Ensures medical team meets or exceeds commitments to Medical Affairs and Development team(s) 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 management and CRPs/CRSs if progress is not adequate.•Monitors progress toward implementation of the other deliverables from the medical team (e.g., publications, field support, medical education), and takes appropriate steps with the responsible cross-functional management team(s) if progress is not adequate.•Responsible for generating, approving, and ensuring the implementation of local support in clinical research studies to meet the business unit's objectives within the resource capabilities.•Works closely with the business unit management to monitor operational expenses of the group and take appropriate actions if there are substantial deviations from approved budgets.

3. Scientific and Technical Expertise

•Maintains his/her deep scientific and technical expertise.•Role model and functional member of the appropriate research, submission, registration and commercialization support teams.• Visibly active in business unit/ therapeutic area and maintains credibility with internal and external colleagues and the larger organization, as well as career satisfaction.•Understands and keeps updated with the pre-clinical, clinical pharmacology, and clinical data relevant to the team's molecule.•Critically reads and evaluates the relevant medical literature; knows the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the team.•Reviews and approves lIT proposals and publications.

4. Scientific data dissemination and exchange

• Oversight of timely dissemination of clinical trial data.• Oversight of the critical analysis of data and the dissemination of data, including but not limited to manuscripts, abstracts, posters, and slide sets.• Oversight of the planning of symposia, advisory board meetings, and other meetings with health care professionals.• Oversight of team's attendance and scientific 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).

5. 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.• Effective business partnering both internally and externally (including but not limited to alliances and joint ventures).• Contribute to the development of medical strategies to support brand commercialization activities by working closely with brand teams, Global Patient Outcomes, Health Outcomes and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.• Ensures team contributes as scientific and medical experts to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.•Contributes actively on an ongoing basis to the strategic planning for the brand.• 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.

6. Regulatory/ submission responsibilities

•Ensures that clinical data generated for regulatory purposes meets all necessary regulatory standards.•Provide support for global registrations, labeling and label modifications, and resolution of regulatory issues.•Oversight and/or participation in Advisory committee(s).•Ensures escalation of drug safety and device issues to appropriate Global Patient Safety area, region and personnel.

7. 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.• Reviews and approves other types of documents in the absence of responsible medical management or CRP/S.• Serves as a member of the local/regional management team, and as such attends management meetings, and contributes to area management process and policy development.• As a member of the management team, is an active and visible representative of the business unit and affiliate, area and/or region.•Participates in various projects, committees, task forces, and other discrete efforts as requested by the business unit medical management.• Participates in activities which include, but not limited to overall business unit plans and budgets, strategic planning, support of efforts of other components such as staff recruiting, and participation on various business unit and corporate committees.• Ensures that new process improvement initiatives and best practices are implemented.•Ensures that team members respect the highest medical ethical standards of Lilly and of the communities where Lilly does business.• Responsible for annual business planning for local activities and/or business unit, and updates regularly.• Responsible for disseminating information and communications to his/her direct reports and colleagues.• Serves as liaison with other functions and business units.• Serves as a role model for and representative of the affiliate/region/area in other organizational venues (e.g., corporate review committees).• Serves as a representative of the affiliate/region/area to groups, committees, or agencies outside the company or the industry.• Manages core activities to appropriately limit direct operational activities so as not to conflict with other core responsibilities such as recruiting, staff development, performance management, business planning, etc.

8. Recruitment

• Participates with medical leadership and business unit leaders, in the human resource needs of the business unit and country.• Oversees implementation of the medical staff recruiting plan, supported by business unit leadership, Human Resources and Global Medical Organization and Development department.• Successful recruiting of clinical research physicians (CRPs) or clinical research scientists (CRSs), Medical Liaisons (as applicable) for the area requiring active involvement and a potential for substantial time commitment.

Minimum Qualification Requirements:

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in cardiology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• 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/2779.htm
• 5 or more years of pharmaceutical industry experience

Additional Skills/Preferences

• Demonstrated experience in leading and managing groups of professionals in senior medical leadership role with examples of successful leadership and influence.
• Demonstrated understanding of the local area/region's medical marketplace
• Demonstrated experience with strong communication, interpersonal, and negotiation skills
• Fluent in English, verbal and written communication

Additional Information

• Ability to travel away from office
• Location: Indianapolis, Corporate Center, USA

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Location: Indianapolis, IN, US

Posted Date: 10/31/2024