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 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 and compliance with corporate patient safety mandates for adverse event reporting
Alignment of activities with strategic priorities of business unit global Medical Affairs team, brand team(s), global Development team, and Therapeutic Area Program Phase

Responsibilities

Provide expert medical support to all aspects of the local business to enhance customers' experience (providers/HCPs and payers)
Participate in development of the "patient journey" and strategic plan for the compound (local marketed product support)
Support development, conduct, and reporting of local clinical trials
Review protocols, study reports, publications, data dissemination, new/updated labels, PRA documents/tools, grant submissions, and contracts
Report adverse events as mandated by corporate patient safety
Handle contacts with regulatory and governmental agencies (e.g., medical support for New/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 with external clinical customer community, including thought leaders
Serve as scientific resource for study teams, departments, and others
Ensure activities align with medical vision and strategic priorities, 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 ReportingRegulatory 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 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 around the world, puts people first, and seeks determined individuals who give their best effort to work, discover life-changing medicines, and give back to communities.

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

Strong candidates will have scientific and medical training, clinical expertise, relevant clinical experience, and the ability to align medical activities with business unit strategic priorities while ensuring compliance with regulations and GCPs.

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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