Senior Medical Director, Clinical Development

🔥 16 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $312.5k - $444k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical 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

• Lead and execute early and/or late stage clinical trials for oncology products in development • Participate in the design and planning of clinical studies and interpret study results • Establish and approve scientific methods for clinical protocol design, data collection systems and final reports • Recruit clinical investigators for research studies as needed • Conduct adverse event reporting and safety event monitoring • Coordinate and develop reporting information for FDA submissions • Monitor protocol adherence and determine study completion • Support clinical trial strategies for oncology products • Design, prepare and initiate study protocols and required documentation in compliance with project plans, federal regulations, GCP and good medical practice • Act as medical monitor for company-sponsored trials, including eligibility and safety-event assessment, data review, protocol writing, investigator and committee presentations, DMC reviews, clinical study reports and publication review • Support project teams with therapeutic-area-specific information • Collaborate with the internal safety group to analyze and report clinical-trial safety data • Analyze and interpret clinical-trial data and prepare reports for regulatory agencies and publication • Interact with key opinion leaders and investigators in relevant disease-specific areas • Ensure consistency of scientific and development strategies • Maintain the highest level of scientific and clinical knowledge in the relevant disease-specific area • Directly supervise employees

🎯 Requirements

• MD and a minimum of 8 years post-residency relevant experience, or equivalent combination of education and experience • Board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential • Minimum of eight years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry • Hands-on experience in the design, execution, medical monitoring, and reporting of controlled clinical trials in oncology • Participation in clinical oncology studies with molecular targeted or immunological therapies • Understanding of basic science relevant to clinical oncology, including biochemistry, immunology, molecular biology and/or genetics • Ability to work effectively in a cross-functional/matrix environment • Broad expertise or unique knowledge and skills supporting company objectives • Ability to develop technical and/or business solutions to complex problems • Ability to identify and implement methods, techniques, procedures and evaluation criteria • Experience leading or managing the work of others • Ability to develop and maintain relationships with key opinion leaders • Strong written and verbal interpersonal, influencing, and presentation skills • Strong organizational and time management skills

🏖️ 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