Clinical Research Medical Director, Endocrinology/Obesity/Diabetes, US - Remote

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Clinical Research Medical Director, Endocrinology/Obesity/Diabetes, US - Remote

What you will do

Let’s do this. Let’s change the world. The Obesity organization is seeking a Medical Director that will work with a team of physician-scientists that support evidence generation for obesity and obesity-related conditions.

Responsibilities:

• Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan for multiple metabolic assets.

• Be able to plan, provide input and guidance to clinical trials design and implementation

• Support 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

• Act as medical monitor during clinical trials execution.

• 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 presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead

• 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)

• Interact with TA leadership and extended team to develop strategies options

• Interact with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications:

Basic Qualifications

• MD or DO degree from an accredited medical school
  AND

• 2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• Five (5) years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) in obesity or obesity-related conditions.

• Eight (8) years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

• Oversee late phase evidence generation from Phase 2 and beyond by leading the design and implementation of the Total Evidence Generation Plan (EGP), including registrational, non-registrational, and real-world evidence

• Previous experience in regulatory interactions and filing activities for Endocrinology/Diabetes/Obesity products

• Experience in biotech or pharma 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

• Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty

• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes

• 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