Clinical Development Medical Director, Early Development – Cardiometabolic
Amgen
Summary
Lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. Collaborate on teams to support the design and delivery of early phase clinical trials. Support protocol development, study start up, data review, monitoring and analysis activities.
Job description
What you will do
Lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. Collaborate on teams to support the design and delivery of early phase clinical trials. Support protocol development, study start up, data review, monitoring and analysis activities.
Responsibilities
- Contribute to the design and implementation of the early clinical development strategy for cardiometabolic/general medicine therapeutic candidates
- Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions
- Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data
- Contribute to the strategy and use of clinical biomarkers to facilitate drug development
- Actively collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety and Commercial colleagues
- Contribute to the evaluation of external licensing or partnering opportunities within the cardiometabolic/general medicine therapeutic areas
- Collaborate with external experts to provide biomedical expertise and strategic guidance to cardiometabolic/general medicine Early Development teams
Basic Qualifications
- MD or DO degree from an accredited medical school
- 2 years of industry or academic/basic sciences/clinical research experience
Preferred Qualifications
- Board certification or eligible
- Residency training in Cardiology, Internal Medicine or relevant subspecialty
- Understanding of cardiometabolic and general medicine pathophysiology
- Experience in basic research and/or clinical trial methodology
- 4+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials
- Experience collaborating with pharmaceutical sponsors
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results
- Demonstrated leadership qualities; capable of conducting studies as part of a team
- Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines
- Publication track record
- Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators
Requirements
- MD or DO degree from an accredited medical school
- 2 years of industry or academic/basic sciences/clinical research experience
- Board certification or eligible
- Residency training in Cardiology, Internal Medicine or relevant subspecialty
- Understanding of cardiometabolic and general medicine pathophysiology
- Experience in basic research and/or clinical trial methodology
- 4+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials
- Experience collaborating with pharmaceutical sponsors
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results
- Demonstrated leadership qualities; capable of conducting studies as part of a team
- Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines
- Publication track record
- Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Retirement and savings plan
- Flexible spending accounts
- Annual bonus program
- 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.