Associate Vice President - Medical Development (Obesity)

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 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.

Purpose:

The Associate Vice President (AVP) - Medical Development - Obesity provides leadership, supervision, coordination, mentoring, career development, and performance management for all activities and individuals within the area of a specified therapeutic or product subgroup of global Development. The AVP - Medical Development - Obesity 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 director may delegate some of his/her duties to a Sr Director - Medical, where such a position exists. In addition to his/her management and focused administrative responsibilities, the AVP - Medical Development - Obesity drives strategic planning and, with clinical plans, team leaders, business unit leadership, and other functional teams within the area, oversees the clinical research and overall medical support activities of the group.

The AVP - Medical Development - Obesity provides strong leadership and the ability to influence, both within and outside the team. The AVP - Medical Development - Obesity supports the clinical staff within his/her product or therapeutic group to ensure high quality, timely submissions, and successful commercialization.

The AVP - Medical Development - Obesity will also interact with external consultants, opinion leaders, and worldwide regulatory agencies, and will provide oversight for responding to medical and regulatory questions and requests related to products. The AVP - Medical Development - Obesity ensures that the team's activities are clearly aligned with Global Patient Safety (GPS), and as appropriate, with Program Phase Medical and Clinical Pharmacology.

The AVP - Medical Development - Obesity plays a significant role in submission, registration, and product launch. In this role, he/she maintains close contact with relevant local and global clinical research management, marketing management, brand, and corporate teams.

The AVP - Medical Development - Obesity is aware of and ensures 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 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 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, and performance appraisals.
• Keeps all performance and career related documents and plans for direct reports up to date.
• Meets regularly with each direct report as active source of coaching and feedback, evaluates progress toward objective fulfillment, evaluates training and development needs, and monitors career development goals.
• Helps each direct report 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.
• 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 leadership, Medical management group, 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 all 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

• 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 operations personnel and CRPs if progress is not adequate.
• Monitors progress toward implementation of the other deliverables from the medical team (e.g., publications, strategic initiatives), 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, and responsible to take appropriate actions if there are substantial deviations from approved budgets.

Scientific and Technical Expertise

• Maintains his/her deep scientific, technical expertise and support.
• Technical oversight in the design of all clinical research activities, including technical review of all team protocols.
• Role model and functional member of the appropriate research and commercialization support teams.
• Promote innovation in drug development, study design/methodology, as well as in implementation and shared learning.
• Visibly active in business unit/therapeutic area and maintains credibility with internal and external colleagues and the larger organization.
• Understand and keep updated with the pre-clinical, clinical pharmacology, and clinical data relevant to the team's molecules.
• Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the team.

Scientific data dissemination and exchange

• Ensures timely dissemination of clinical trial data.
• Ownership or lead in the development of publication plan/activities.
• Oversight of the critical analysis of data and ensures the dissemination of data, including but not limited to manuscripts, abstracts, posters, and slide sets, medical information.
• 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).

Regulatory/submission responsibilities

• Knowledge of the regulatory demands for successful registration planning.
• 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.
• Advisory committee participation as assigned.
• Ensures escalation of drug safety and device issues to GPS.

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 direct report(s).
• Serves as a member of the business unit management team, and as such attends management meetings, and contributes to area management process and policy development.
• Participates in various projects, committees, task forces, and other discrete efforts as requested by the group director/executive management.
• 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.
• Provide ownership/collaborative leadership for transition coordination: (Program to Global Brand Development; Pre-launch to Post-launch).
• 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.
• Provide clinical support for the business unit/therapeutic area regarding business development opportunities (in-licensing/acquisitions) as needed.
• Responsible for disseminating information and communications to his/her direct reports and colleagues.
• Serves as liaison with corporate entities as assigned by senior management.
• Serves as a role model for and representative of Development in business unit in other organizational venues (e.g., corporate review committees)
• Serves as a representative of development 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

• Responsible for determining the human resource needs for the development area and overseeing implementation of the staff recruiting plan, supported by executive management, Human Resources and Global Medical Capabilities and Development.
• Successful recruiting of clinical research physicians (CRPs) or clinical research scientists (CRSs) for the area.

Minimum Qualification 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. 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). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
• Three to five years of demonstrated experience in clinical research/drug development including the design and implementation of large Phase 3 global clinical trials.
• Supervisory experience with demonstrated evidence for the capacity to lead and manage groups of physicians and/or research scientists.
• Demonstrated administrative skills, including strong teamwork skills
• Demonstrated evidence of the ability to work within Lilly's governance and cross-functional 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

Additional Preferences:

• Demonstrated experience in Phase 3 Obesity Drug Development
• Pediatric drug development experience

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$274,500 - $402,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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