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Clinical Science Director

đź•’ vor 1 Monat

🏄 California – Remote

infoinfo

đź’µ $195.000 - $277.500 / Jahr

⏰ Vollzeit

đź”´ Experte

đź‘” Direktor

🗣️🇺🇸🇬🇧 Englisch erforderlich

Woher diese Stelle stammt

Veröffentlicht auf der Karriereseite von Exelixis, nicht über eine Jobbörse

Von Remote Rocketship zum ersten Mal gesehen vor 1 Monat

Noch offen auf der Website von Exelixis. GeprĂĽft vor 7 Stunden.

Logo of Exelixis

Exelixis

1001 - 5000 Mitarbeiter

GegrĂĽndet 1994

🏥 Gesundheitswesen

🧬 Biotechnologie

đź’Š Pharmazie

💰 €65.000.000 Post-IPO Equity im 2012-02

Healthcare • Biotechnology • Pharmaceuticals

Exelixis ist ein Biotechnologie- und Pharmaunternehmen, das sich auf die Entwicklung von Krebsbehandlungen durch innovative Forschung und Entwicklung konzentriert. Das Unternehmen engagiert sich für den Fortschritt in der Onkologie durch die Schaffung wirkungsvoller Krebsmedikamente, einschließlich Biotherapeutika und kleinmolekularer Therapien. Exelixis legt großen Wert auf klinische Studien, Kooperationen und eine Vielzahl von Behandlungsmodalitäten, mit dem Ziel, Krebspatienten Hoffnung zu geben. Darüber hinaus hat sich Exelixis der Nachhaltigkeit, Vielfalt und Gemeinschaftsunterstützung verpflichtet, wie in ihren Unternehmenswerten und -praktiken zum Ausdruck kommt.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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

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