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Executive Medical Director Obesity
Live
What you will do
Lets do this. Lets 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.
Additional Qualifications/ResponsibilitiesWhat 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
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