Clinical Science Director

🔥 25 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $195k - $277.5k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Exelixis

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1994

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $65M Post-IPO Equity on 2012-02

Healthcare • Biotechnology • Pharmaceuticals

Exelixis is a biotechnology and pharmaceutical company focused on developing cancer treatments through innovative research and development. The company is committed to advancing oncology by creating impactful cancer medicines, including biotherapeutics and small molecule therapies. Exelixis places a strong emphasis on clinical trials, collaborations, and a diverse range of treatment modalities, aiming to provide hope to cancer patients. Additionally, Exelixis is dedicated to sustainability, diversity, and community support, as reflected in their corporate values and practices.

📋 Description

• 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 • Support project teams with scientific information and provide progress updates on assigned clinical studies • 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 with clinical operations and internal study teams • Serve as clinical study team contact for medical monitor inquiries with guidance and oversight • Develop agendas, training materials, and presentations for site visits, investigator meetings, and other study-related venues • Participate in internal safety meetings and analyze and report potential safety events • Review and interpret study data for health authority reports, regulatory filing documentation, and study close-out reports • Write and/or review product-specific abstracts and publications and support presentations for scientific meetings • Provide feedback on emerging clinical and competitive trends • Coordinate and facilitate clinical oncology studies while maintaining relationships with study 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

🎯 Requirements

• 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 • Participation in clinical oncology studies with molecular targeted or immunological therapies • Comprehensive and detailed knowledge of clinical trial implementation and drug development process • Experience in the design, execution, and reporting of clinical trials in oncology with small and large molecule drug candidates • Strong analytical and business communication skills • Highly organized and able to work under tight timelines • Good public speaking and presentation skills • Ability to work on complex problems requiring in-depth evaluation of various factors • Ability to exercise judgment within broadly defined practices and policies • Ability to use professional concepts and company policies and procedures to solve difficult problems • Ability to network with key contacts outside own area of expertise • 10-25% travel requirement

🏖️ Benefits

• 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 • Disability accommodation support