Executive Director, Clinical Development

Career Category

Clinical Development

Job Description

JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Executive Medical Director, Obesity

Live

What you will do

Let’s do this. Let’s change the world. The Obesity organization is seeking an Executive Medical Director that will oversee a team of physician-scientists that support evidence generation for obesity and obesity-related conditions, as well as supporting and reporting into the Vice President, Obesity.

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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• MD or DO degree from an accredited medical school AND

• Five years of industry or academic  research AND

• 6 years of managerial experience directly managing people and/or leadership  experience leading teams, projects, programs or directing the allocation of resource

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

• Leaders