Associate Vice President Global & US Medical Affairs Immunology
PharmaBiotechmedical
Job description
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. The Associate VP, Global Medical Affairs – Immunology (Rheumatology, Respiratory & Pipeline) 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. The Associate VP, Global Medical Affairs – Immunology (Rheumatology, Respiratory & Emerging Immuno-Metabolism) 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, Global Medical Affairs – Immunology (Rheumatology, Respiratory & Emerging Immunology-Metabolism) may delegate some of his/her duties to a Director- Medical. In addition to his/her management and administrative responsibilities, the Associate VP, Global Medical Affairs – Immunology (Rheumatology, Respiratory & Emerging Immuno-Metabolism) 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, Global &US Medical Affairs – Immunology (Rheumatology, Respiratory & Emerging Immuno-Metabolism) 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, Global & US Medical Affairs – Immunology (Rheumatology, Respiratory & Emerging Immuno-Metabolism) 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, Global & US Medical Affairs – Immunology (Rheumatology, Respiratory & Pipeline) 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. 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
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