Exel
Senior Director, Clinical Operations Compliance Management (GCP/Biotechnology/Oncology)
Alameda, CA · Director
Sponsorship not specified$246k-$350kDetected 31 days ago
GCPExcelProcurementClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationProblem SolvingTime ManagementPublic SpeakingOrganizational SkillsMicrosoft Office
About the role
- Key activities include focus on risk management, issue management, vendor oversight and site and data monitoring.
- This Leader focuses on streamlining and standardizing cross-functional processes and templates as well as supporting development on the use of systems managed by the Clinical Operations function.
- Work Environment/Physical Demands: Our office is a modern, open-plan space that foster collaborations and creativity.
Responsibilities
- Provide support to Clinical Operations (and other functions being supported by embedded compliance role) CAPA owners, including owner assignment, follow-up and completion.
- May manage direct reports and/or consultants.
- COCM drives a common approach to study conduct, compliance, risk and issue management as well as management of protocol deviations.
- The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
Requirements
- Bachelor's degree in related discipline and a minimum of 15 years of related experience
- Master's degree in related discipline and a minimum of 13 years of related experience
- Doctoral degree in related discipline and a minimum of 12 years of related experience
- Experience in biotech/pharmaceutical industry required.
- 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.
Skills
- Leadership and networking skills.
- Communication and engagement skills.
- Partnership and collaboration skills.
- In-depth knowledge of biopharmaceutical industry regulations, standards and best practices.
- 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.
- Bachelor's degree in related discipline and a minimum of 15 years of related experience; or,
- Master's degree in related discipline and a minimum of 13 years of related experience; or,
Compensation
- The base pay range for this position is $246,000 - $349,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
- Define strategy and methodology for functional risk/issue management, create annual functional risk management plan to ensure inspection readiness, review periodically the outcomes of risk management/management monitoring; collaborate cross-functionally on risk management activities, and escalate to appropriate governance and adapt accordingly.
Benefits
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
- Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.