Skip to contentExecutive Medical Director – Global Development
| Company | Amgen |
|---|
| Location | Thousand Oaks, CA, USA |
|---|
| Salary | $343334 – $403728 |
|---|
| Type | Full-Time |
|---|
| Degrees | MD |
|---|
| Experience Level | Senior, Expert or higher |
|---|
Requirements
- 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
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.
Preferred Qualifications
- 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
