Sr. Director (Medical) Oral Therapies at Eli Lilly and Company

Mexico City, Mexico City, Mexico

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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
Ability to develop or contribute to the medical plan in the therapeutic area of responsibility
Knowledge of 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
Awareness of and ability to ensure compliance with all medical affairs regulations and alignment with medical vision

Responsibilities

Provide expert medical support to all aspects of the local business to enhance customers' experience (providers/HCPs and payers)
Participate in the development of the "patient journey" and strategic plan for the compound (local marketed product support)
Support development, conduct, and reporting of local clinical trials
Report adverse events as mandated by corporate patient safety
Review protocols, study reports, publications, data dissemination, new/updated labels, PRA documents/tools, grant submissions, and contracts
Engage in contacts with regulatory and governmental agencies (e.g., medical support for New and Supplemental New Drug Submissions, participate/present at Cofepris meetings)
Provide medical support for pricing, reimbursement, and access (PRA) (guidance on PRA plan, interact with government PRA agencies)
Lead local scientific data dissemination (lead/present at conferences, advisory boards; oversee scientific content of educational programs)
Conduct outreach medical activities aimed at external clinical customer community, including thought leaders
Serve as scientific resource for study teams, departments, and others
Align activities with strategic priorities of business unit global Medical Affairs team, brand team(s), global Development team, and Therapeutic Area Program Phase (with input from Director-Medical and Business Unit Team Physician/Regional Medical Leader)

Skills

Key technologies and capabilities for this role

Clinical ResearchMedical AffairsTherapeutic Area ExpertiseStrategic PlanningClinical TrialsAdverse Event ReportingProtocol ReviewRegulatory AffairsThought Leader EngagementProduct LaunchCommercialization

Questions & Answers

Common questions about this position

What is the employment type for this position?

The position is full-time.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What key skills and expertise are required for the Sr. Director (Medical) Oral Therapies role?

The role requires scientific and medical training, clinical expertise, relevant clinical experience, and knowledge of regulations such as FDA, ICH, CPMP, and Good Clinical Practices (GCPs).

What is the company culture like at Eli Lilly and Company?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and seeks determined individuals who give their best effort while focusing on patients, providers, payers, philanthropy, and volunteerism.

What makes a strong candidate for this Clinical Research Physician role?

Strong candidates will have scientific and medical training, clinical expertise, relevant experience, and the ability to align activities with business unit strategies while ensuring compliance with regulations and supporting clinical trials, medical plans, and outreach to thought leaders.

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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