Clinical Development Director – Early Development, Inflammation/Rare Disease

🕒 Setembro 4

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $274.788 - $371.773 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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