Clinical Development Director – Early Development, Cardiometabolic/General Medicine

🕒 July 23

🇺🇸 United States – Remote

💵 $274.8k - $371.8k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept • Collaborate on teams to support the design and delivery of early phase clinical trials • Support protocol development, study start up, data review, monitoring and analysis activities • Contribute to the design and implementation of the early clinical development strategy for cardiometabolic/general medicine therapeutic candidates • Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions • Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data • Contribute to the strategy and use of clinical biomarkers to facilitate drug development • Actively collaborate with Amgen Precision Medicine, Research, Late Development, Regulatory, Safety and Commercial colleagues • Contribute to the evaluation of external licensing or partnering opportunities within the cardiometabolic/general medicine therapeutic areas • Collaborate with external experts to provide biomedical expertise and strategic guidance to cardiometabolic/general medicine Early Development teams

🎯 Requirements

• MD or DO degree from an accredited medical school AND 2 years of industry or academic/basic sciences/clinical research experience • Board certification or eligible (Internal Medicine, Cardiology, or Endocrinology) • Residency training in Internal Medicine and relevant subspecialty • Understanding of cardiometabolic and general medicine pathophysiology • Experience in basic research and/or clinical trial methodology • 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials • Experience collaborating with pharmaceutical sponsors • Experience in designing, monitoring and implementing clinical trials and interpreting trial results • Demonstrated leadership qualities; capable of conducting studies as part of a team • Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines • Publication track record • Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators.

🏖️ 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, 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.