Executive Director, Clinical Development - Thousand Oaks, CA

Executive Director, Clinical Development - Thousand Oaks, CA

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

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 by 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.

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

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

They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results