Associate Clinical Operations Compliance Director – Biotechnology Oncology

🕒 6 days ago

🇺🇸 United States – Remote

💵 $168.5k - $238.5k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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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

• Support the risk and issue management process for Clinical Operations • Contribute to functional risk and issue management strategy and methodology • Assist in creating the annual functional risk management plan for inspection readiness • Collaborate cross-functionally on risk management activities and escalate issues to governance • Support Clinical Operations CAPA owners with assignment, follow-up and completion • Assist with updates on CAPA completion data • Liaise with Quality Assurance and other functional teams across R&D • Build standardized GCP and process training curriculum • Drive capability and knowledge sharing • Build and renew quality metrics for Clinical Operations • Drive continuous inspection readiness across studies • Keep the TMF audit-ready and run mock inspections • Follow up on CAPAs and lead BIMO and health authority inspection response • Oversee monitoring quality and CRO performance • Oversee risk-based monitoring signals and escalate site and data issues • Perform other duties as assigned • Comply with all policies and standards

🎯 Requirements

• Bachelor’s degree in related discipline and a minimum of 11 years of related experience; or Master’s degree and a minimum of 9 years; or Doctoral degree and a minimum of 5 years; or equivalent combination of education and experience • Experience in biotech/pharmaceutical industry required • Current understanding of the relevant external scientific, legal and regulatory environment • Strong knowledge of biopharmaceutical industry regulations, standards and best practices • Ability to work independently with minimal supervision • Analytical, strategic thinking, problem-solving, time management, change management and organizational skills • Strong interpersonal, verbal and written communication skills • Strong attention to detail • Ability to identify and communicate issues and risks • Excellent presentation skills • Ability to build and maintain strong relationships • Ability to influence without direct authority • Excellent computer skills, including advanced knowledge of Microsoft Excel, Word, PowerPoint and Outlook

🏖️ 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 in relation to the recruiting process