Senior Director Global Medical Affairs (Cardiovascular/Cardiometabolic Health) at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Scientific and medical training, clinical expertise, and relevant clinical experience
Awareness and compliance with current local and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, and Principles of Medical Research
Ability to serve as a scientific resource for study teams, departments, and others
Experience in strategic planning for launch and commercialization activities

Responsibilities

Provide expert medical support to all aspects of local/global business, including marketed product support (development of patient journey and strategic plan for compounds)
Develop or contribute to global and/or regional clinical/medical plans in therapeutic area of responsibility
Develop, conduct, and report clinical trials; implement global clinical trials in local affiliates/countries
Report adverse events as mandated by corporate patient safety
Review protocols, study reports, publications, data dissemination, new/updated labels, documents/tools for product pricing, reimbursement, access (PRA), grant submissions, and contracts
Interact with regulatory and governmental agencies; provide medical support for New and Supplemental New Drug Submissions and meetings
Provide medical support for pricing, reimbursement, and access (PRA) plans and interactions with agencies
Lead scientific data dissemination (present at conferences, advisory boards; oversee scientific content of educational programs)
Conduct outreach medical activities with external clinical customer community, including thought leaders
Support demand realization through various medical activities
Work closely with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams
Ensure all medical team activities (and direct reports, if applicable) align with medical vision and compliance standards

Skills

Clinical Research

Medical Affairs

Strategic Planning

Clinical Trials

Adverse Event Reporting

Protocol Review

Study Reports

Publications

Data Dissemination

Cardiovascular Medicine

Cardiometabolic Health

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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