Medical Sciences Medical Director - Early Development - Cardio-metabolic
Amgen is a leading global biotechnology company, with a mission to serve patients around the world. As a science based, patient focused organization, we discover and develop innovative therapies to treat serious illnesses. Our medicines have made a dramatic difference in the lives of millions. To underpin our commitment to serve patients, Amgen continues to develop our translational medicine focus in the cardiovascular-metabolic therapeutic area in support of preclinical and clinical programs.
Early Development is looking for a strong scientific leader in the cardiovascular-metabolic therapeutic area. This individual will be responsible for providing scientific/ medical direction and leadership for pre-clinical/ early clinical programs for Amgen's Early Development cardiovascular-metabolic pipeline. The Medical Director will lead the early phase clinical development of compounds in the cardiovascular-metabolic therapeutic area from first-in-man studies through proof of concept and translational projects as part of the initial drug development strategy. This individual will also serve as the Evidence Generation Team leader for one or more of Amgen's Product Teams through his or her role as an Early Development Leader (EDL).
This Medical Director will be responsible for representing Early Development during interactions with other Amgen functions and key external stakeholders including regulatory agencies and the scientific community. In addition, he or she will be responsible for enhancing Amgen's scientific capabilities in the area cardiovascular-metabolic therapeutic area.
- Serve as an internal clinical expert for translational and clinical programs in the cardiovascular-metabolic therapeutic area
- Serve as medical monitor for clinical trials and assists in resolving major issues that may affect the studies
- Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams
- Provide guidance and assistance in the identification and management of phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
- Ensure appropriate training, recruitment, and development requirements for matrix team resources
- Will be the primary Early Development contact for basic scientists in discovery research as well as for clinical research scientists overseeing later clinical development
- Evaluate external opportunities for partnering or licensing new cardiovascular-metabolic assets
This position can be located in either Thousand Oaks, CA, or San Francisco, CA.
MD/DO degree from an accredited medical school
2 years of clinical research experience and/or basic science research
- Subspecialty board eligibility/certification in Internal Medicine, Gastroenterology, Cardiology or Endocrinology
- Strong basic science or clinical research background in academia or industry
- Prior experience authoring, monitoring, analyzing, and presenting clinical trial data
- Excellent interpersonal, verbal and written communication skills and the experience of successfully functioning in a highly matrixed team environment
- Ability to anticipate problems and find creative solutions
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints
- A record of high quality peer-reviewed publications
- An understanding of regulatory requirements necessary for the various phases of drug development and experience interacting with regulators
- Demonstrated ability of flexibility, efficiency and diplomacy both individually and as part of a team effort
- Previous experience in early phase development and/or biomarker work
- Previous experience in late stage clinical trials and regulatory filings
- Demonstrated expertise in conducting translational and/or clinical research
- Expertise in Spotfire or other data analysis tools
- Knowledge of GCP, EMA, and FDA policies
- Expertise in authoring clinical sections of CTA or INDs
Culture plays a pivotal role in our ability to succeed in our goals.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.