Clinical Development Director, Obesity/Cardiovascular

What you will do

Let’s do this. Let’s change the world. Amgen is advancing our Obesity and Cardiometabolic pipeline. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.

The Obesity Therapeutic Area is seeking a Clinical Development Director to play a vital role on one or more late phase studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this role, you will report directly to the Global Development Lead for cardiovascular indications.

• Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for maridebart cafraglutide (AMG 133) phase 3 program(s).
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
• Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results.
• Serve as medical monitor for ongoing clinical trials
• Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
• Participate and provide clinical input into safety and regulatory interactions
• Author 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 Global Development Lead

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.

MD or DO degree from an accredited medical school

AND

3 years of clinical research experience

• Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), ideally in late phase development in a cardiometabolic or adjacent therapeutic area.
• Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• 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 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications
• Experience with clinical trial medical data review, medical monitoring and or safety review and interpretation, including use of electronic aggregate data review tools
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions

• Strong communication & presentation skills to clearly communicate scientific 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
• 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

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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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:

• A 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship for this role is not guaranteed.

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Salary Range