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Associate Vice President - Medical Affairs

3+ years
Not Disclosed
10 March 25, 2025
Job Description
Job Type: Full Time Education: MD/DO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Vice President - Medical Affairs
Location: Indianapolis, Indiana, United States
Category: Medical
Job Type: Full-Time, Regular
Job ID: R-79452

Company Overview:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We are committed to discovering and delivering life-changing medicines that improve lives around the world. Our employees work tirelessly to advance medical understanding, enhance disease management, and give back to communities through philanthropy and volunteerism.

Compensation:
Actual compensation is based on education, experience, skills, and geographic location.
Anticipated Salary Range: $252,000 - $369,600

Purpose:
The Associate Vice President - Medical Affairs Clinical Research Physician (CRP) provides scientific and medical expertise to the medical affairs, development, and brand teams. The CRP contributes to strategic planning for product launch, commercialization, and life cycle management. Key responsibilities include supporting regulatory activities, engaging with external thought leaders, facilitating clinical trials, and ensuring compliance with global medical standards.

Responsibilities:

Business/Customer Support:

  • Understand and anticipate scientific information needs of payers, patients, and healthcare providers.

  • Address customer inquiries through data analysis and clinical research.

  • Develop medical strategies for brand commercialization.

  • Provide clinical insights for payer partnerships and product value defense.

  • Support regulatory affairs and interactions with government agencies.

  • Assist in developing educational programs and promotional materials.

  • Lead patient journey definition and provide medical insights.

Scientific Data Dissemination/Exchange:

  • Ensure compliance with local and global regulations for scientific data dissemination.

  • Lead symposia, advisory board meetings, and other interactions with healthcare professionals.

  • Prepare and review medical information materials and scientific publications.

  • Establish and maintain relationships with thought leaders and professional societies.

  • Support congress activities, including poster presentations and customer engagement.

Clinical Planning:

  • Collaborate with global Medical Affairs, Development teams, and Patient Outcomes to align clinical strategies with customer needs.

  • Communicate local research requirements to global teams for Phase 3b/4 and earlier phase studies.

  • Keep updated on pre-clinical and clinical data relevant to assigned molecules.

Clinical Research/Trial Execution:

  • Review informed consent documents and ensure risk communication compliance.

  • Collaborate with clinical research teams to design and conduct local trials.

  • Identify and select investigators and ensure GCP compliance.

  • Provide training to investigators and site personnel.

  • Monitor patient safety and follow up on adverse events per corporate patient safety policies.

Regulatory Support Activities:

  • Collaborate with global Development and brand teams to develop and review local labeling.

  • Provide medical expertise to regulatory teams and support registration efforts.

  • Participate in risk management planning and regulatory advisory committees.

Scientific/Technical Expertise and Development:

  • Stay informed on clinical practices, trends, and competitive products.

  • Critically evaluate medical literature and scientific developments relevant to assigned products.

  • Act as a scientific consultant and protocol expert for clinical study teams.

General Responsibilities:

  • Support medical leadership in budget planning and administration.

  • Set and achieve professional development goals.

  • Provide coaching and feedback to colleagues and direct reports.

  • Collaborate with alliance, business, and vendor partners to ensure clinical and medical alignment.

Qualifications:

  • MD, DO, or equivalent with relevant clinical and research experience.

  • Strong knowledge of regulatory and compliance requirements (FDA, ICH, GCP, etc.).

  • Demonstrated ability to collaborate with cross-functional teams.

  • Excellent communication and leadership skills.

Location: Indianapolis, Indiana, United States
Job ID: R-79452