Senior Director, Clinical Operations Compliance Management – GCP, Biotechnology, Oncology

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $246k - $349.5k / year

⏰ Full Time

🟠 Senior

🏥 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 clinical research activities comply with ICH GCP, international and local regulations, guidelines and Exelixis standards • Lead risk and issue management for Clinical Operations and support compliant study execution • Provide trends and relevant reporting to Process Owners, Clinical Operations and Leadership Teams • Translate trends into process improvements and risk-based decisions • Define functional risk and issue management strategy and methodology • Create an annual functional risk management plan to support inspection readiness • Review risk management and management-monitoring outcomes • Collaborate cross-functionally on risk management activities and escalate issues to appropriate governance • Support Clinical Operations CAPA owners with assignment, follow-up and completion • Provide development leadership with CAPA completion updates • Liaise with Quality Assurance and functional teams across R&D and beyond • Drive a common approach to study conduct, compliance, risk and issue management, and protocol deviations • Support inspection readiness and cross-study consistency in execution and compliance • Streamline and standardize cross-functional processes and templates • Support development and use of Clinical Operations systems • Use internal and external data to identify change drivers and recommend process improvements • Lead, design and drive changes across a complex network of stakeholders and subject matter experts • Embed a risk and issue management framework • May manage direct reports and/or consultants

🎯 Requirements

• Bachelor’s degree in related discipline and a minimum of 15 years of related experience; or Master’s degree and a minimum of 13 years; or Doctoral degree and a minimum of 12 years; or equivalent combination of education and experience • Minimum of 15 years of related experience and/or combination of education/training and experience • Experience in the biotech/pharmaceutical industry required • Experience involving CROs, R&D outsourcing, purchasing or procurement roles required • Senior-level leadership and management experience involving external suppliers • Current understanding of the relevant external scientific, legal and regulatory environment • Prior experience leading a team • In-depth knowledge of biopharmaceutical industry regulations, standards and best practices • Leadership, networking, communication, engagement, partnership, collaboration and influencing skills • Strong 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 • Ability to work independently with minimal supervision and adapt to changing business plans and priorities • Willingness to travel occasionally, less than 10%

🏖️ 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