Clinical Operations Compliance Director – Biotechnology Oncology

🕒 6 days ago

🇺🇸 United States – Remote

💵 $179.5k - $256k / 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

• Ensure oncology clinical research activities comply with ICH GCP, applicable international and local regulations, industry standards, and Exelixis policies and procedures • Provide strategic and operational leadership for Clinical Operations compliance activities • Lead and continuously improve the Clinical Operations risk and issue management program • Identify, assess, mitigate and escalate risks affecting clinical trial quality, compliance and execution • Develop and implement functional risk management strategies and annual risk management plans • Review, analyze and communicate compliance trends, quality metrics, key risk indicators and inspection-readiness measures • Oversee CAPAs, including ownership, tracking, timely completion and effectiveness evaluation • Provide Clinical Operations leadership with updates and recommendations on CAPAs, compliance risks, trends and emerging issues • Collaborate with Quality Assurance on internal audits, regulatory inspections, inspection readiness and follow-up actions • Develop, implement and drive adoption of standardized processes, templates and best practices across studies • Facilitate resolution and escalation of significant operational and quality issues through governance structures • Oversee clinical vendors and CRO partnerships for quality and compliance adherence • Use operational and compliance data to identify process improvement and risk reduction opportunities • Serve as subject matter expert and provide guidance, training and consultation on Clinical Operations compliance processes • Foster a culture of quality, inspection readiness and proactive compliance management across R&D • Build standardized GCP and process training curricula, capability programs and quality metrics • Drive inspection readiness, TMF audit readiness, mock inspections, CAPA follow-up and BIMO/health authority inspection responses • Oversee monitoring quality, CRO performance, risk-based monitoring signals and escalation of site and data issues • Perform other duties as assigned and comply with policies and standards

🎯 Requirements

• Bachelor's degree in related discipline and a minimum of 13 years of related experience; or Master's degree in related discipline and a minimum of 11 years of related experience; or Doctoral degree in related discipline and a minimum of 8 years of related experience; or equivalent combination of education and experience • Experience in biotech/pharmaceutical industry required • Experience in biotech/pharmaceutical industry involving CROs, R&D outsourcing, purchasing or procurement roles required • Evidence of leadership and management skills in a relevant industry role involving strong engagement with external suppliers • Prior experience leading a team • Current understanding of the relevant external scientific, legal and regulatory environment • In-depth knowledge of biopharmaceutical industry regulations, standards and best practices • Leadership, networking, communication, engagement, partnership, collaboration and influencing skills • Ability to work independently with minimal supervision • Excellent 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 during the recruiting process