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Senior Director, Gps Medical

0-2 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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

Job Title: Senior Director, GPS Medical
Location: Indianapolis, Indiana, United States
Category: Research & Development
Job Type: Full-Time, Regular
Job Id: R-74643

Company Overview

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 work across the globe to discover and deliver life-changing medicines. We aim to improve disease understanding, enhance treatments, and contribute to our communities through philanthropy and volunteerism. We seek individuals who are determined to make a positive impact on the lives of others.


Position Overview

The Senior Director, GPS Medical is responsible for assessing and ensuring the safety of Lilly products, communicating safety information to customers and regulatory bodies, and maximizing the safe use of Lilly products in the best interest of patients, healthcare professionals, and the corporation. This leadership role involves managing a global team of physicians and clinical research scientists, overseeing safety assessments for both investigational and marketed products, and ensuring regulatory compliance. The Senior Director will also drive proactive safety monitoring and manage safety communications related to assigned products.


Key Responsibilities

Leadership and People Management

  • Recruit, retain, and develop clinical research scientists and clinical safety physicians to support safety assessment and communication for specific products.
  • Lead and facilitate regular meetings, feedback discussions, career development, and succession planning.

Support for GPS Medical Activities

  • Develop and implement processes to ensure the safety of development compounds and approved products.
  • Review and approve safety communications to regulatory authorities and customers for assigned products.
  • Collaborate with medical, marketing, and affiliate teams, ensuring the efficient implementation of processes and roles.

Global Medical Leadership

  • Provide medical leadership for safety assessment and surveillance programs, risk management planning, and regulatory submissions for assigned compounds/products.
  • Build strong working relationships with global development and brand teams to ensure the medical evaluation of safety data aligns with regulatory standards.
  • Represent GPS Medical in product development committees, brand teams, and other relevant meetings.

Compliance and Safety Reporting

  • Ensure compliance with Lilly's global safety and regulatory standards, including the Red Book and corporate policies.
  • Participate in safety-related publications and presentations.
  • Support the Qualified Person (QPPV) role by providing the necessary support for legal responsibilities.

Training and Mentoring

  • Foster development through mentoring and training, maintaining personal and team expertise in relevant therapeutic areas and safety practices.
  • Promote Global Patient Safety (GPS) curriculum and expertise within the team.

Qualifications

Required

  • Medical Doctor (MD) or Doctor of Osteopathy (DO), board eligible or certified in a relevant specialty/subspecialty.
  • US-trained physicians must be board eligible or certified.
  • Foreign medical graduates must have completed education and training at a recognized medical school (LCME accredited).

Preferred

  • Clinical research or pharmaceutical medicine experience.
  • Knowledge of the drug development process.
  • Fluent in English with strong written and verbal communication skills.
  • Excellent interpersonal, organizational, and negotiation abilities.
  • Ability to influence others cross-functionally to create a collaborative working environment.
  • Strong teamwork and leadership skills.

Additional Preferences

  • Willingness to engage in domestic and international travel as required by the business.

Compensation and Benefits

  • Anticipated Salary Range: $214,500 - $314,600 (dependent on education, experience, skills, and geographic location)
  • Bonus: Eligible for a company bonus based on performance.
  • Benefits: Comprehensive benefits package, including medical, dental, vision, and prescription drug benefits, 401(k) with company match, flexible spending accounts, life insurance, paid time off, and wellness programs.

Equal Opportunity Employer Statement

Lilly is an EEO/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

Lilly encourages individuals with disabilities to actively engage in the workforce, ensuring equal opportunities during the application process. If you need accommodations to submit a resume, please complete the accommodation request form on our careers page.


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