Clinical Science Director – Biotech Oncology

🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $195.000 - $277.500 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Exelixis

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1994

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $65.000.000 Post-IPO Equity em 2012-02

Healthcare • Biotechnology • Pharmaceuticals

A Exelixis é uma empresa de biotecnologia e farmacêutica focada no desenvolvimento de tratamentos contra o câncer por meio de pesquisa e desenvolvimento inovadores. A empresa se compromete a avançar na oncologia através da criação de medicamentos contra o câncer impactantes, incluindo bioterapêuticos e terapias com pequenas moléculas. A Exelixis dá grande importância a ensaios clínicos, colaborações e a uma ampla gama de modalidades de tratamento, com o objetivo de oferecer esperança aos pacientes com câncer. Além disso, a Exelixis se dedica à sustentabilidade, diversidade e apoio à comunidade, como refletido em seus valores e práticas corporativas.

Descrição

• Design, plan, and develop early- and/or late-phase clinical oncology studies • Prepare and author clinical development documents, including study synopses and protocols • Summarize study results for documents and publications • Provide scientific information and progress updates to project teams • Design, prepare, and initiate study protocols and required documentation in compliance with project plans, federal regulations, GCP, and good medical practice • Interact with oncology investigators and thought leaders to facilitate clinical synopses and protocols • Research and assist in selecting investigators for clinical studies • Conduct literature research for assigned clinical product candidates • Develop Informed Consent Forms, Case Report Forms, and CRF instructions • Support medical monitor inquiries with guidance and oversight • Develop agendas, training materials, and presentations for site visits and investigator meetings • Participate in internal safety meetings and analyze and report potential safety events • Review and interpret study data for health authority reports, regulatory filings, and study close-out reports • Write and/or review product-specific abstracts and publications and support scientific meeting presentations • Provide feedback on emerging clinical and competitive trends • Coordinate and facilitate clinical oncology studies while maintaining relationships with investigators • Deliver scientific presentations on Exelixis investigational agents to physicians and external customers • Provide clinical education support for internal Exelixis customers • Maintain clinical and technical expertise in oncology

🎯 Requisitos

• Pharm.D., PhD, or M.D. and a minimum of 8 years of related experience; or equivalent combination of education and experience • 5-8 years of clinical development experience in the biotechnology or pharmaceutical industry or equivalent combination of academia and industry • Experience participating in clinical oncology studies with molecular targeted or immunological therapies • Comprehensive and detailed knowledge of clinical trial implementation and the drug development process • Experience designing, executing, and reporting clinical trials in oncology with small and large molecule drug candidates • Ability to identify and implement methods and procedures to achieve high-quality results • Strong analytical and business communication skills • Highly organized and able to work under tight timelines • Good public speaking and presentation skills • Ability to exercise judgment within broadly defined practices and policies • Ability to solve difficult problems using professional concepts and company policies and procedures • 10-25% travel requirement

🏖️ Benefícios

• 401k plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Opportunity to purchase company stock • Long-term incentives • 15 accrued vacation days in the first year • 17 paid holidays including a company-wide winter shutdown in December • Up to 10 sick days throughout the calendar year • Necessary equipment, including dual monitors and ergonomic chairs