Clinical Development Medical Director, Obesity/Cardiovascular

🕒 September 24

🇺🇸 United States – Remote

💵 $274.8k - $371.8k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide clinical and scientific knowledge for the development, design, delivery, and communication of the global evidence generation plan for the maridebart cafraglutide (AMG 133) Phase 3 program • Work cross-functionally to translate clinical strategy into study concept documents, study protocols, and related documents • Provide clinical input into and implement clinical trials, including delivery, clinical data review, and interpretation of results • Serve as medical monitor for ongoing clinical trials • Review and analyze clinical trial data for accuracy, completeness, protocol adherence, and regulatory compliance • Participate in and provide clinical input for safety and regulatory interactions • Author clinical study reports, publications, and regulatory submissions • Develop relationships with key opinion leaders and present scientific information at advisory boards, scientific meetings, and external committee meetings • Report directly to the Global Development Lead for cardiovascular indications

🎯 Requirements

• MD or DO degree from an accredited medical school • 3 years of clinical research experience • Three (3) or more years of clinical research experience in the biopharmaceutical industry preferred • Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities preferred • Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes • Experience developing study concepts and clinical trial designs with cross-functional input in Phase 2 and/or 3 trials in obesity, diabetes, or cardiovascular indications • Experience with clinical trial medical data review, medical monitoring, and/or safety review and interpretation, including electronic aggregate data review tools • Experience drafting high-level submission documents and authoring clinical regulatory responses • Strong written and oral communication and presentation skills • Strong interpersonal skills and problem-solving abilities • Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements • Leadership experience or potential as a medical expert in a complex matrix environment

🏖️ Benefits

• 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 • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support

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