Location: Redwood City, CA

Overview

The Associate Director of Clinical Operations will work directly with the Head of Clinical Operations to provide expertise and oversight over multiple clinical trials or a clinical program to ensure trials are conducted in accordance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocols.  Will provide leadership and direction to the Clinical Operations team in the management of CROs and other vendors.

Principle Duties and Responsibilities Include:

• Provide strategic input to Clinical Development Plans and other strategic planning activities
• Lead cross-functional teams to ensure excellent study execution from data integrity, patient safety, quality, compliance, budget, and timeline adherence perspectives
• Assist in the development of SOPs and/or Best Practices to ensure quality and compliance of each clinical study
• Participate in the review and selection of clinical sites and vendors
• Prepare and negotiate clinical trial site budgets
• Develop and maintain positive working relationships with all internal and external study team members
• Train the study team on the protocol and study specifics, continue to work closely with clinical core team to ensure quality and compliance of clinical trial data
• Lead CRO Team Meetings; provide direction to in creating meaningful agendas, documenting, and tracking decisions, outcomes, and deliverables
• Provide monitoring instruction and oversight, address issues as they arise, and co-monitor with CRO’s Monitors to evaluate and ensure quality of CRO Monitoring Team
• Organize (or assist with organizing) and participate in meetings – i.e., Investigator Meetings, Monitors’ workshops, and CRO Training
• Triage CRO and clinical site questions
• Perform oversight of trials to ensure that safety concerns and/or adverse events/SAEs are properly documented, tracked, and reported
• Proactively identify risks and lead team members to mitigate risks in a timely fashion
• Oversee data clarification process as needed in conjunction with selected CRO and ensure database lock according to agreed timeline
• Support remediation and corrective efforts of sites, vendors, contractors and CROs
• Work with Drug Supply to ensure adequate supply and accountability of study drug at all active sites
• Maintain training records for Study Specific areas i.e.: Protocol
• Communicate and provide oversight for external vendors, and know when and how to escalate issues
• Work with the clinical team to build and maintain TMFs for adherence to regulatory obligations

Qualifications/Requirements:

• B.S. or Nursing degree (Master’s degree preferred) in a scientific or health related field with a minimum of 8 years experience in a Clinical Research capacity  
• Extensive clinical experience in the management of clinical vendors
• Strong leadership qualities with the ability to motivate, influence and guide team members
• Strong understanding of clinical site budgets
• Ability to recognize changes to amendments and the overall impact to timelines and budgets
• Current and strong working knowledge interpretation/implementation of the Code of Federal Regulations and ICH Guidelines governing clinical trials.
• Strong verbal and written communication skills; including ability to clearly present information and respond to questions from project teams and vendors
• Ability to escalate and mitigate issue up through resolution
• Proven management skills with the ability to prioritize multiple projects
• Proficiency with MS Word, Excel, Outlook, and PowerPoint
• Possible travel of approximately 10-20%

To Apply

Interested and qualified candidates should send their resume to recruiting@rezolutebio.com. to the attention of Human Resources.

Rezolute (RZLT) currently anticipates the base salary for the Associate Director of Clinical Operations role could range from $175,000 to $190,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.