Amgen · 3 months ago
Executive Director, Clinical Development
Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. They are seeking an Executive Director for Clinical Development to oversee a team focused on evidence generation for obesity and related conditions, providing clinical and scientific input throughout the development process.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for multiple metabolic assets
Support (and lead when requested) cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
Participate and provide clinical input into safety and regulatory interactions
Interpret and communicate clinical trial data
Oversee the authoring of clinical study reports, publications and regulatory submissions
Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated the Vice President
Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
Contribute to TPP (target product profile) and Global Product Safety (GPS) development
Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG), and Portfolio Governance
Interact with TA leadership and extended team to develop strategics options
Interact and collaborate with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options
Provide clinical and scientific input to business development interactions including due diligence processes
Qualification
Required
MD or DO degree from an accredited medical school
Five years of industry or academic research
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred
Five (5) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) in obesity or obesity-related conditions
Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
Previous experience in regulatory interactions
Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Leadership experience/potential as a medical expert in a complex matrix environment
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path
Benefits
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Recent News
2026-01-16
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