Eli Lilly
Sr. Director - Medical Development-Obesity
Eli Lilly, Indianapolis, Indiana, United States, 46201
Senior Medical Director
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. The Senior Medical Director is delegated various responsibilities by the Medical Development AVP 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 while supporting the management team in fulfilling corporate goals and initiatives. The Senior Medical Director will provide strong leadership and ability to influence, both within and outside the team. The Senior Medical Director supports the clinical staff within his/her product or therapeutic group to ensure high quality, timely submissions, and successful commercialization. The Senior Medical Director 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 Senior Medical Director participates in strategic planning for and oversight of the clinical research and medical support activities of the Director's area of responsibility. The Senior Medical Director 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 Senior Medical Director 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 Senior Medical Director plays a significant role in submission, registration, and product launch. In this role, the Senior Medical Director maintains close contact with relevant local and global clinical research management, marketing management, and corporate teams. In the absence of the Medical Development AVP, the Senior Medical Director may carry out certain responsibilities of the Director. The Senior Medical Director 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 Senior Medical Director 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, 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. Specific responsibilities may include but are not limited to: Maintains deep scientific, technical expertise and support, conducting activities in clinical research, submission, and commercialization support balanced with administrative activities as agreed upon by Medical Development AVP. Provides technical expertise, protocol development oversight, and input into development of informed consent documents. Understands and keeps updated with the pre-clinical, clinical pharmacology, and clinical data relevant to the team 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. Is a role model and functional member of the appropriate research, submission, registration, and commercialization support teams. Is 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. Reviews and approves llT proposals and publications, as requested by Medical Development AVP. Helps 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. Supports the planning of symposia, advisory board meetings, and other meetings with health care professionals. Oversees 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). Ensures that clinical data generated for regulatory purposes meets all necessary regulatory standards. Provides support for global registrations, labeling and label modifications, and resolution of regulatory issues. Participates in advisory committee as assigned. Ensures that medical team he/she supports is trained, and compliant with local, global, and company standards with regard to interactions with customers. Establishes 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. Engages in effective business partnering both internally and externally (including but not limited to marketing/sales, joint ventures, affiliate awareness). In coordination with the Medical Development AVP, 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 Medical Development AVP. Contributes actively on an ongoing basis to the strategic planning for the brand. Takes a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Becomes a patient advocate, as well as a medical expert. Oversees 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. 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. Is responsible for retaining talented people for the long term. Is responsible for presenting the activities, desires, capabilities, and achievements of direct reports to the Medical Development AVP, Medical management group, HR, and Global Medical Capabilities and Development department for talent assessment, performance evaluation, and timely promotion consideration. Is accountable for CRP/S capacity planning and work allocation. Recognizes and appropriately rewards exceptional performance, talent, and/or contribution. Leads and appropriately delegates 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. Respects the value and contributions of paramedical technical talent on the team. Partners with cross-functional team members to assist the Medical Development AVP in the development of the clinical strategy and clinical plans. Partners 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 takes appropriate steps with the responsible cross-functional management team(s) if progress is not adequate. Works closely with the Medical Development AVP to monitor operational expenses of the group, and takes appropriate actions if there are substantial deviations from approved budgets. 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 Medical Development AVP. Participates in various projects, committees, task forces, and other discrete efforts as requested by executive
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. The Senior Medical Director is delegated various responsibilities by the Medical Development AVP 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 while supporting the management team in fulfilling corporate goals and initiatives. The Senior Medical Director will provide strong leadership and ability to influence, both within and outside the team. The Senior Medical Director supports the clinical staff within his/her product or therapeutic group to ensure high quality, timely submissions, and successful commercialization. The Senior Medical Director 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 Senior Medical Director participates in strategic planning for and oversight of the clinical research and medical support activities of the Director's area of responsibility. The Senior Medical Director 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 Senior Medical Director 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 Senior Medical Director plays a significant role in submission, registration, and product launch. In this role, the Senior Medical Director maintains close contact with relevant local and global clinical research management, marketing management, and corporate teams. In the absence of the Medical Development AVP, the Senior Medical Director may carry out certain responsibilities of the Director. The Senior Medical Director 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 Senior Medical Director 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, 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. Specific responsibilities may include but are not limited to: Maintains deep scientific, technical expertise and support, conducting activities in clinical research, submission, and commercialization support balanced with administrative activities as agreed upon by Medical Development AVP. Provides technical expertise, protocol development oversight, and input into development of informed consent documents. Understands and keeps updated with the pre-clinical, clinical pharmacology, and clinical data relevant to the team 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. Is a role model and functional member of the appropriate research, submission, registration, and commercialization support teams. Is 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. Reviews and approves llT proposals and publications, as requested by Medical Development AVP. Helps 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. Supports the planning of symposia, advisory board meetings, and other meetings with health care professionals. Oversees 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). Ensures that clinical data generated for regulatory purposes meets all necessary regulatory standards. Provides support for global registrations, labeling and label modifications, and resolution of regulatory issues. Participates in advisory committee as assigned. Ensures that medical team he/she supports is trained, and compliant with local, global, and company standards with regard to interactions with customers. Establishes 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. Engages in effective business partnering both internally and externally (including but not limited to marketing/sales, joint ventures, affiliate awareness). In coordination with the Medical Development AVP, 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 Medical Development AVP. Contributes actively on an ongoing basis to the strategic planning for the brand. Takes a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Becomes a patient advocate, as well as a medical expert. Oversees 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. 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. Is responsible for retaining talented people for the long term. Is responsible for presenting the activities, desires, capabilities, and achievements of direct reports to the Medical Development AVP, Medical management group, HR, and Global Medical Capabilities and Development department for talent assessment, performance evaluation, and timely promotion consideration. Is accountable for CRP/S capacity planning and work allocation. Recognizes and appropriately rewards exceptional performance, talent, and/or contribution. Leads and appropriately delegates 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. Respects the value and contributions of paramedical technical talent on the team. Partners with cross-functional team members to assist the Medical Development AVP in the development of the clinical strategy and clinical plans. Partners 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 takes appropriate steps with the responsible cross-functional management team(s) if progress is not adequate. Works closely with the Medical Development AVP to monitor operational expenses of the group, and takes appropriate actions if there are substantial deviations from approved budgets. 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 Medical Development AVP. Participates in various projects, committees, task forces, and other discrete efforts as requested by executive