Clinical Development Director – Obesity, Cardiovascular

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 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/scientific knowledge for the development, design, delivery, and communication of the global evidence generation plan for the AMG 133 Phase 3 program • Work cross-functionally to translate clinical strategy into study concept documents, protocols, and related documents • Provide clinical input into and implement clinical trials • Review clinical data and interpret 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 into safety and regulatory interactions • Author clinical study reports, publications, and regulatory submissions • Develop relationships with key opinion leaders • Make scientific presentations 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 for clinical development and clinical trial designs with cross-functional input 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 electronic aggregate data review tools • Experience drafting high-level submission documents for regulatory submissions, including 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

• 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 • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support