Senior Director-Medical-Immunology

Industry:

Company: Eli Lilly and Company

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 Sr. Director-Medical is delegated various responsibilities by the Associate Vice President-Medical or equivalent role to provide leadership, supervision, coordination, coaching, career development, and performance management for the staff within a specified therapeutic or product subgroup of Development in the Business Unit. The position is a developmental role for future administrative leaders and is intended to provide a balance of administrative and technical responsibilities. The position requires a partial transition from direct CRP contributor to managerial/supervisory responsibilities and activities of achieving results through others, and supporting the management team in fulfilling corporate goals and initiatives. The Sr. Director-Medical will provide strong leadership, ability to influence, both within and outside the team. The Sr. Director-Medical supports the clinical staff within his/her product or therapeutic group to ensure high quality, timely submissions, and successful commercialization. The Sr. Director-Medical may be delegated such responsibilities as approval authority for grants and contracts, protocols and protocol amendments, label changes, scientific e-disclosure, informed consent documents, travel authorizations, expense reports, and other documents related to the work of the group.

In addition to his/her focused administrative responsibilities, the Sr. Director-Medical participates in strategic planning for and oversight of the clinical research and medical support activities of the Director’s area of responsibility.

The Sr. Director-Medical 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 Sr. Director-Medical helps to ensure that the team’s activities are clearly aligned with Global Patient Safety (GPS), and as appropriate, with Program Phase Medical and Clinical Pharmacology. The Sr. Director-Medical plays a significant role in submission, registration, and product launch. In this role, the Sr. Director-Medical maintains close contact with relevant local and global clinical research management, marketing management, and corporate teams. In the absence of the Associate Vice President-Medical, the Sr. Director-Medical may carry out certain responsibilities of the Director. The Sr. Director-Medical maintains the ongoing responsibilities of a Clinical Research Physician for product support and clinical research in his/her area (see area job description for CRP for review of core job responsibilities), adjusted and balanced to the level and extent as appropriate to correspond to the needs of the area and role.

The Sr. Director-Medical 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.

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.
• 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 corporation.
• Responsible for retaining talented people for the long term.
• Responsible for presenting the activities, desires, capabilities, and achievements of direct reports to the Associate Vice President-Medical, Medical management group, HR, and Global Medical Capabilities and Development department for talent assessment, performance evaluation, and timely promotion consideration.
• Accountable for CRP/S capacity planning and work allocation.
• Recognizes and appropriately rewards exceptional performance, talent, and/or contribution.
• Lead and appropriately delegate to the physicians and clinical research scientists on the team who are responsible for clinical development plans.
• 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

• Respect the value and contributions of paramedical technical talent on the team.
• Partner with cross-functional team members to assist the Associate Vice President-Medical in the development of the clinical strategy and clinical plans.
• Partner with the medical leadership in effective budget planning and integration of clinical/business plans.
• Ensures placement of the clinical welfare of patients and subjects using a Lilly product or participating in a Lilly clinical investigation above all other considerations.
• Ensures medical group meets or exceeds commitments 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 the other deliverables from the medical team and take appropriate steps with the responsible cross-functional management team(s) if progress is not adequate.
• Works closely with the Associate Vice President-Medical to monitor operational expenses of the group, and takes appropriate actions if there are substantial deviations from approved budgets.

Scientific and Technical Expertise

• Maintains his/her deep scientific, technical expertise and support, conducting activities in clinical research, submission, and commercialization support balanced with administrative activities as agreed upon by Associate Vice President-Medical.
• Provide technical expertise, protocol development oversight, and input into development of informed consent documents.
• Understand and keep updated with the pre-clinical, clinical pharmacology, and clinical data relevant to the team molecule.
• 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.
• Role model and functional member of the appropriate research, submission, registration, and commercialization support teams.
• Visibly active in business unit/her therapeutic area to maintain credibility with internal and external colleagues and the larger organization, as well as to enhance career satisfaction.
• Review and approve llT proposals and publications, as requested by Associate Vice President-Medical

Scientific Data Dissemination and Exchange

• Ensures timely dissemination of clinical trial data.
• Help to ensure the critical analysis of data and the dissemination of that data, including but not limited to manuscripts, abstracts, posters, and slide sets. Works closely with statistical and global scientific communications colleagues.
• Support 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 (before 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.
• Establish effective collaborations with marketing personnel on the brand team and in the various geographic regions to further demand realization, including promotional material review and sales training.
• Effective business partnering both internally and externally (including but not limited to marketing/sales, joint ventures, affiliate awareness and understanding).
• In coordination with the Associate Vice President-Medical, ensures adequate support for review and approval of promotional materials.
• Supports the strategy and/or negotiations for drug reimbursement with national health authorities as assigned by the Associate Vice President-Medical.
• Contribute 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.
• Oversight of team’s contributions 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.

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.
• Advisory committee participation as assigned.

Overall Administrative Responsibilities

• Serves as a member of the business unit development management team, and as such attends meetings, and contributes to area management process and policy development as requested by Associate Vice President-Medical.
• Participates in various projects, committees, task forces, and other discrete efforts as requested by executive management.
• Participates in activities which includes, 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 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.
• May participate in succession planning for the area.
• May participate in annual business planning for local activities with the Associate Vice President-Medical.
• Approval responsibility for the entire group remains with the Associate Vice President-Medical. The Sr. Director Medical may be delegated responsibilities or serve as the backup for the Associate Vice President-Medical for review of major business documents requiring director-level approval in his/her absence. 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 Associate Vice President-Medical or CRP/S.
• Responsible for disseminating information and communications to his/her direct reports and colleagues.
• Ensure collaboration between team members and Global Patient Safety (GPS).
• Coordinate collaborations with other business unit CRPs, Program Phase and Clinical Pharmacology, and Discovery colleagues as necessary.
• Serves as liaison with affiliates/geographical regions as assigned by Associate Vice President-Medical.
• Provide coaching and feedback to other team members.

Additional Corporate Responsibilities

• As a member of the management team, is an active and visible representative of the corporate function.
• Be an effective partner/team player with other functions.
• Serves as a role model for and representative of physicians for the team in other organizational venues (e.g., corporate review committees).
• Serves as a representative of the global brand team to groups, committees, or agencies outside the company or the industry as assigned by Associate Vice President-Medical.

Recruitment

• Participates with the Associate Vice President-Medical, in conjunction with the business unit and DCOE 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 requiring involvement and a potential for substantial time commitment.

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.
• U.S. trained physicians must have achieved board eligibility or certification.
• Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
• Non-U.S. 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

Additional Preferences:

• Preferred experience in gastroenterology, drug development and/or people management.

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