Clinical Development Medical Director, Obesity and Related Conditions
Amgen
Summary
Amgen is advancing our Obesity and Cardiometabolic pipeline. The Obesity Therapeutic Area is seeking a Clinical Development Director to play a vital role on one or more late phase studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this role, you will report directly to the Global Development Lead for cardiovascular indications.
Job description
What you will do
Amgen is advancing our Obesity and Cardiometabolic pipeline. The Obesity Therapeutic Area is seeking a Clinical Development Director to play a vital role on one or more late phase studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this role, you will report directly to the Global Development Lead for cardiovascular indications.
- Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for maridebart cafraglutide (AMG 133) phase 3 program(s).
- Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents.
- Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results.
- Serve as medical monitor for ongoing clinical trials.
- Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements.
- Participate and provide clinical input into safety and regulatory interactions.
- Author 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 by Global Development Lead.
Basic Qualifications
- MD or DO degree from an accredited medical school
- 3 years of clinical research experience
Preferred Qualifications
- Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), ideally in late phase development in a cardiometabolic or adjacent therapeutic area.
- Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities.
- 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 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications.
- Experience with clinical trial medical data review, medical monitoring and or safety review and interpretation, including use of electronic aggregate data review tools.
- Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions.
- Strong communication & presentation skills to clearly communicate scientific 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.
- 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.
Requirements
- MD or DO degree from an accredited medical school
- 3 years of clinical research experience
- Three or more years of clinical research experience in the biopharmaceutical industry, ideally in late phase development in a cardiometabolic or adjacent therapeutic area
- Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
- 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 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications
- Experience with clinical trial medical data review, medical monitoring and or safety review and interpretation, including use of electronic aggregate data review tools
- Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
- Strong communication & presentation skills
- Strong interpersonal skills and problem-solving abilities
- 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
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Retirement and Savings Plan
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.