Temp Associate Director, Clinical Operations

W2 Contract

Location: Redwood City, CA - Onsite Role

Job Summary:

This role is a unique opportunity for a Clinical Operations Professional. As an Associate Director in Clinical Operations, you will act as a central contact for the Clinical Study Team(s) and assist with the execution and management of clinical trials.

Duties and Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
• Be a team leader, providing guidance and oversight for successfully managing all aspects of clinical trials within timelines and designated program budgets.
• Review and comment on the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs, including timelines, budget, and resource requirements. Identify critical path activities and articulate and mitigate risks to clinical trial conduct.
• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants) for project and non-project related tasks.
• Line management responsibilities include hiring, performance management, career development, and mentorship.
• Manage/oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and key performance indicators (KPIs).
• Able to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.
• Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, Quality Assurance, Finance, Legal, etc.) to achieve clinical study goals.
• Ensure clinical trials maintain an inspection readiness state throughout the trial's lifecycle.
• Partner with Clinical Operations team members and functional peers to improve processes that will impact clinical trial management and deliverables, including contingency plans.

Requirements and Qualifications:

• Bachelor's degree in biological sciences or a health-related field
• 10+ years of direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.
• Minimum of 4 years of project and line management experience.
• Extensive experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets.
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
• Experience with vendor management and CRO oversight.
• Ability to perform complex analysis, draw relevant conclusions, and implement appropriate solutions.
• Strong analytical, negotiation, and persuasion skills.
• Ability to deal with time demands, incomplete information, or unexpected events.
• Outstanding organizational skills with the ability to multitask and prioritize.
• Excellent interpersonal, verbal, and written communication skills.
• Strong decision-making skills.
• Comfortable in a fast-paced company environment and able to adjust workload based on changing priorities.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~25%).

Preferred Qualifications:

• RN or Master's degree in biological sciences or a health-related field preferred.
• Familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.
• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
• Experience in working with cooperative group studies and investigator-sponsored trials is preferred.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.