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Temporary Development Operations Compliance Director at Exelixis, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Alameda, California





Job Description:

Position Description:
Support the Executive Director in implementing strategies and tactics to promote and maintain GCP compliance and process improvements for clinical trial activities performed by the Development Operations departments: Clinical Operations, Biostatistics, Clinical Data Management, Statistical & Clinical Programming. Provide Good Clinical Practice (GCP) guidance and best-practice expertise to facilitate optimal clinical trial execution compliance management and ensure study adherence to applicable GCP regulations throughout all phases of clinical development. In addition, this role will support the organization by creating and implementing processes to improve quality and data integrity for clinical trials and ensure continuous inspection readiness according to GCP guidelines.

Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Collaborate with all Development Operations functions to confirm adherence to GCP compliance execution through all stages of clinical trial conduct including but not limited to: core study execution documents, clinical trial sponsor oversight, issue escalation, internal/external audit support.
• Co-lead Development Operations inspection preparation activities.
• Review supportive clinical trial documents (e.g., manuals, study plans, etc.) for compliance with regulations, regulatory guidelines and standard operating procedures.
• Write and review operational SOPs and provide input during the review of cross-functional SOP review.
• Identify and support remediation of any compliance issues for assigned clinical studies and functional areas.
• Partner in Root Cause Analyses and advises on content of CAPAs and audit report responses.
• Partner with the Quality Assurance group on remediation of quality issues related to conduct of clinical studies.
• Co-lead compliance activities including SOP and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R2).
• Develop and conduct training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in study execution and on-going adherence to standards and regulations.

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and eleven years of related experience; or,
• MS/MA degree in related discipline and nine years of related experience; or,
• PhD in related discipline and six years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience:
• A minimum of 15 years of related experience and/or combination of experience and education/training.
• 12 years of pharmaceutical/biotechnology/CRO in quality management of clinical trials, training, clinical operations, project management.
• Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
• Experienced in leading inspection readiness activities
• Experienced in leading the development of SOPs and other process related documentation.
• Experienced in supporting clinical trial GCP compliance/quality management activities.
• Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials.
Knowledge/Skills/Abilities:
• Has supported GCP inspection readiness activities and participated in regulatory authority inspections.
• Expertise in implementation of the FDA BIMO manual for inspections of sponsors and CROs.
• Excellent interpersonal and communication skills, both written and oral, including ability to develop strong relationships with both internal and external customers and to timely escalation of conflicts for resolution.
• Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely.
• Problem-solving, process improvement, analytical, and collaborative skills.
• Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change.

JOB COMPLEXITY:
• Applies judgement and professional expertise in new situations.
• Independent team member performing highly technical or specialized work.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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