Associate Vice President Global & US Medical Affairs Immunology

Eli Lilly and Company • Us, IN

4d • Hybrid

About The Position

The Associate VP, Global Medical Affairs – Immunology (Rheumatology, Respiratory & Emerging Immuno-Metabolism) role 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. This role has review responsibilities and approval authority for grants and contracts, label changes, protocols and protocol amendments, informed consent documents, travel authorizations, expense reports, and other documents related to the work of the therapeutic area group. The Associate VP may delegate some of his/her duties to a Director- Medical. In addition to his/her management and administrative responsibilities, the Associate VP drives strategic planning and, through clinical plans managers, team leaders, and close collaboration with the other functional teams within the area, oversee the clinical research and overall medical support activities of the group. The Associate VP is responsible for assuring that the group's activities are clearly aligned with the strategic priorities of the respective business unit 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 Associate VP maintains open, collaborative contact and relationships with global and affiliate clinical research, partnerships or collaborations, global Development team(s), and marketing management and staff. The Associate VP 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.

Requirements

• 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.
• Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).
• 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.
• Minimum of seven years of experience in Medical Affairs and/or Clinical Research.

Nice To Haves

• Demonstrated understanding of the US medical marketplace, including payer evidence requirements, HCP engagement standards, and US affiliate Medical Affairs operations, in addition to the global medical landscape.
• Demonstrated experience leading and managing groups of physician and scientific professionals across multiple therapeutic areas; preferred specialty or experience in immunology/rheumatology, respiratory, and/or metabolic areas, with examples of successful leadership and influence in matrixed global/affiliate environments.
• Demonstrated experience with strong communication, interpersonal, and negotiation skills
• Ability to travel away from office
• Fluent in English, verbal and written communication

Responsibilities

• 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/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 Capabilities 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.
• Oversight of clinical planning, budgeting, and execution
• Responsible for affiliate evaluation and input into clinical planning and contribution to clinical trials across the asset lifecycle (Phase 1/2 through Phase 4), and communicates research needs to global Development team, Global Patient Outcomes/Real World Evidence, and Pricing, Reimbursement & Access (PRA) teams to ensure clinical programs meet the needs of patients, prescribers, and payers in both global and US markets.
• Responsible for the local/regional clinical planning process including external research where applicable 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, Program 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) 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 takes appropriate actions if there are substantial deviations from approved budgets.
• Medical Affairs shift-left contribution for pipeline assets
• Drives MA plans for the TAs accountable for AND Including Phase 1/2 molecules in the portfolio (that are not GI or Derm).
• Partners with Research, Early Phase Clinical Pharmacology, Translational Medicine, and Program Phase teams to shape target product profiles, clinical development plans, and evidence strategy from first-in-human through registration.
• Coordinates with development and Marketing but also IR teams and other TAs (Derm, GI) and Incretin GBD lead and HEOR seamless transitioning form pipeline to TAs where applicable
• Accountable for Medical Affairs Integrated Evidence Generation (IEG) plans, the Integrated Roadmap (IR), and Cross-functional Clinical Governance (CCG) forums for assets in the TA portfolio, ensuring real-world, payer, and customer evidence needs are reflected in pre- and post-PoC decision-making.
• Deep 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 keeps updated with medical and other scientific developments relevant to the team.
• Reviews and approves IIT proposals and publications.
• 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).
• Business/ customer support (pre and post launch)
• Ensures that medical team he/she supports is trained, and compliant with local, global, and company standards about 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/Real World Experience 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.
• 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.
• Overall Administrative Responsibilities
• Reviews and approves major business documents that require director-level approval, including research protocols and amendments, contracts and grants, informed consent forms, 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 are 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.
• 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 Capabilities 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree