Clinical Development Director – Early Development, Inflammation/Rare Disease

🔥 11 hours ago

🇺🇸 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 and IND development, study start-up, data review, monitoring and analysis activities • Contribute to the design and implementation of early clinical development strategy for Inflammation, General Medicine or Rare Disease therapeutic candidates • Contribute to 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 • Collaborate with Precision Medicine, Research, Clinical Pharmacology, Operations, Late Development, Regulatory, Safety and Commercial colleagues • Contribute to evaluation of external licensing or partnering opportunities within cardiometabolic/general medicine therapeutic areas • Collaborate with external experts to provide biomedical expertise and strategic guidance to Early Development teams

🎯 Requirements

• MD or DO degree from an accredited medical school • 2 years of industry or academic/basic sciences/clinical development experience • Board certification or eligible (Internal Medicine, relevant subspecialty) (preferred) • Residency training in Internal Medicine and relevant subspecialty (preferred) • Understanding of pathophysiology of inflammatory, general medicine, and/or rare diseases (preferred) • Experience in basic research and/or clinical trial methodology (preferred) • 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials (preferred) • Experience collaborating with pharmaceutical sponsors (preferred) • Experience in designing, monitoring and implementing clinical trials and interpreting trial results (preferred) • Demonstrated leadership qualities; capable of conducting studies as part of a team (preferred) • Experience within a matrix environment, contributing to decision-making and reaching alignment in order to meet challenging timelines (preferred) • Publication track record (preferred) • Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators (preferred) • Sponsorship for this role is not guaranteed

🏖️ 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 • 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