Sr. Director - Medical Development - T2D
Eli Lilly and Company
5 hours ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Purpose
- Sr. Director-Medical provides leadership, supervision, coordination, coaching, career development, and performance management for staff within a specified therapeutic or product subgroup of Development.
- Balances administrative and technical responsibilities; transitions from direct CRP contributor to managerial/supervisory responsibilities.
- Ensures high quality, timely submissions, successful commercialization, and compliance with local and international regulations, GCP, and company policies.
Primary Responsibilities
- Career development and performance management of direct reports (plans, appraisals, coaching/mentoring, training needs, documentation, retention).
- CRP/S capacity planning and work allocation; recognize/reward performance.
- Lead/delegate to physicians and clinical research scientists; ensure adequate qualification and training (curriculum training map).
- Oversight of clinical planning, budgeting, and execution; monitor operational expenses and act on budget deviations.
- Partner with cross-functional teams to develop clinical strategy/plans and integrate clinical/business plans.
- Ensure patient/subject welfare is prioritized; ensure commitments for clinical research are met and monitor progress on plans and deliverables.
- Provide scientific/technical expertise: protocol development oversight; informed consent document input; stay current on relevant clinical data and literature.
- Disseminate clinical trial data; support analysis and dissemination (manuscripts, abstracts, posters, slides); plan symposia/advisory boards; oversee congress attendance/support.
- Regulatory/submission responsibilities: ensure regulatory-standard data; support global registrations and labeling; resolve regulatory issues; advisory committee participation.
- Administrative/corporate responsibilities: participate in management team activities, committees/projects, succession and local annual business planning as assigned; implement process improvements; maintain medical ethics.
- Document approvals and backup: may be delegated or serve as backup for Associate Vice President for director-level document review/approval (e.g., protocols/amendments, contracts/grants, informed consent, label changes, travel expenses).
- Liaison with affiliates/geographical regions; coaching/feedback; coordinate with other CRPs, Program Phase/Clinical Pharmacology, and Discovery.
- Recruitment involvement for determining HR needs and implementing recruiting plans for CRPs/CRSs.
Minimum Qualification Requirements
- MD or DO; board eligible/certified in appropriate specialty/subspecialty or completed comparable post-medical school clinical training relevant to country of hiring (US-trained physicians must be board eligible/certified).
- Non-US trained physicians: completed education/training at a medical school meeting LCME requirements.
- Non-US trained, not US board eligible/certified may be hired in the US at the discretion of the Chief Medical Officer.
Additional Information/Preference
- Regulatory interactions or large Phase 3 pivotal studies execution.
- Endocrinology specialty.
- Clinical research/drug development experience, including design and implementation of large global clinical trials.
- Demonstrated ability to lead/manage professionals; administrative skills.
- Ability to work within Lilly governance structure.
- Strong communication, interpersonal, negotiation skills; domestic/international travel as needed.
Benefits (if explicitly included)
- Eligibility for company bonus.
- Company-sponsored 401(k), pension; vacation.
- Medical/dental/vision/prescription coverage; flexible benefits; life insurance/death benefits.
- Time off/leave of absence benefits; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application Instructions
- Internal applicants must meet minimum qualifications and have/obtain work authorization in the country of the role; applying notifies the current supervisor. Discuss the opportunity with your supervisor before applying.
- Sr. Director-Medical provides leadership, supervision, coordination, coaching, career development, and performance management for staff within a specified therapeutic or product subgroup of Development.
- Balances administrative and technical responsibilities; transitions from direct CRP contributor to managerial/supervisory responsibilities.
- Ensures high quality, timely submissions, successful commercialization, and compliance with local and international regulations, GCP, and company policies.
Primary Responsibilities
- Career development and performance management of direct reports (plans, appraisals, coaching/mentoring, training needs, documentation, retention).
- CRP/S capacity planning and work allocation; recognize/reward performance.
- Lead/delegate to physicians and clinical research scientists; ensure adequate qualification and training (curriculum training map).
- Oversight of clinical planning, budgeting, and execution; monitor operational expenses and act on budget deviations.
- Partner with cross-functional teams to develop clinical strategy/plans and integrate clinical/business plans.
- Ensure patient/subject welfare is prioritized; ensure commitments for clinical research are met and monitor progress on plans and deliverables.
- Provide scientific/technical expertise: protocol development oversight; informed consent document input; stay current on relevant clinical data and literature.
- Disseminate clinical trial data; support analysis and dissemination (manuscripts, abstracts, posters, slides); plan symposia/advisory boards; oversee congress attendance/support.
- Regulatory/submission responsibilities: ensure regulatory-standard data; support global registrations and labeling; resolve regulatory issues; advisory committee participation.
- Administrative/corporate responsibilities: participate in management team activities, committees/projects, succession and local annual business planning as assigned; implement process improvements; maintain medical ethics.
- Document approvals and backup: may be delegated or serve as backup for Associate Vice President for director-level document review/approval (e.g., protocols/amendments, contracts/grants, informed consent, label changes, travel expenses).
- Liaison with affiliates/geographical regions; coaching/feedback; coordinate with other CRPs, Program Phase/Clinical Pharmacology, and Discovery.
- Recruitment involvement for determining HR needs and implementing recruiting plans for CRPs/CRSs.
Minimum Qualification Requirements
- MD or DO; board eligible/certified in appropriate specialty/subspecialty or completed comparable post-medical school clinical training relevant to country of hiring (US-trained physicians must be board eligible/certified).
- Non-US trained physicians: completed education/training at a medical school meeting LCME requirements.
- Non-US trained, not US board eligible/certified may be hired in the US at the discretion of the Chief Medical Officer.
Additional Information/Preference
- Regulatory interactions or large Phase 3 pivotal studies execution.
- Endocrinology specialty.
- Clinical research/drug development experience, including design and implementation of large global clinical trials.
- Demonstrated ability to lead/manage professionals; administrative skills.
- Ability to work within Lilly governance structure.
- Strong communication, interpersonal, negotiation skills; domestic/international travel as needed.
Benefits (if explicitly included)
- Eligibility for company bonus.
- Company-sponsored 401(k), pension; vacation.
- Medical/dental/vision/prescription coverage; flexible benefits; life insurance/death benefits.
- Time off/leave of absence benefits; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application Instructions
- Internal applicants must meet minimum qualifications and have/obtain work authorization in the country of the role; applying notifies the current supervisor. Discuss the opportunity with your supervisor before applying.