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Executive Director, Clinical Development

Executive Director, Clinical Development

AmgenNewbury Park, CA, US
30+ days ago
Job type
  • Full-time
Job description

Executive Medical Director, Obesity

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 strategic 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.

What we expect of you :

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
  • What you can expect of us :

    As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

    The annual base salary range for this opportunity in the U.S. is $343,334 - $403,728.

    In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
  • Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

    We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

    Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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