Associate Director, Clinical Operations - Brisbane, CA | Biospace
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Associate Director, Clinical Operations

Aimmune Therapeutics

Location:
Brisbane, CA
Posted Date:
5/30/2017
Position Type:
Full time
Job Code:
17-70-CO-N
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Clinical Operations, Director,

Job Description


The Associate Director of Clinical Operations will be responsible for the planning and efficient conduct of the clinical operations of research and development programs.  The Associate Director provides leadership and supervision for the Clinical Research Associates and serves as a technical and scientific resource in the conduct of Phase II to Phase IV Clinical Trials.

ESSENTIAL DUTIES:

Responsible for clinical operation timelines, and planning activities for each clinical study. Develop and mentor clinical staff and consultants, and secure sufficient resources to support the company’s goals and objectives.  Will manage and hire a growing team of clinical research professionals.

Directs and manages the overall execution of clinical trials in accordance with regulations, GCPs and/or Company SOPs in all clinical operations activities.  These activities include but are not limited to:

•Managing and assisting the team to ensure activities such as the development of protocols, case report forms, investigator’s brochures, consent forms, study manuals and specifications are completed in accordance with timelines
•Assuring timelines are developed for each clinical trial, communicated and managed in accordance with corporate timelines and goals.
•Assuring the clinical studies are adequately monitored, data is collected in timely fashion and cleaned for all trials.
•Assuring site selection activities are completed, appropriate information is collected and reviewed to enable timeline and efficient investigator selection
•Assuring all functions internal and external are set up and managed to enable efficient start-up of sites.
•Effectively interfaces with other functional departments (e.g. Data Management, Biostatistics, Safety, Program Leadership, Regulatory and CMC) to facilitate completion of cross-functional study tasks and enhance communication
•Assuring accurate estimates for clinical trial material needs are provided to CMC to plan for and adequately provision IP for each study
•Assisting with overall study budget development for new studies (e.g. CRO, Investigator fees, pass through fees) and providing information conjunction with the Finance Department.
•Ensuring the budgets for external services are tracked by clinical operations to provide status regarding contract to budget actual.
•Assist with budget forecasting and accruals as requested
•Responsible for the development, preparation, maintenance and adherence of team members to clinical operations SOPs.
•Responsible for ensuring training records are in place for clinical operations departments.
•Provide regular updates and report on key milestones and study progress

Requirements


Education and/or experience:

•BS in Life Sciences required
•Minimum of 15 years clinical operations experience with 3 years in an Associate Director level role as well as a minimum of 5 years managing internal and external contract operations in the biotechnology or pharmaceutical industry required.
•Strong leadership and team management skills and experience required.
•Extensive Vendor and Clinical Operations Management experience required.
•Management of Phase I-III clinical trials, including multi-center, and multi-country registration trials.
•Experience with compliance issues, corrective action procedures and strong understanding of FDA Regulations, GCP and/or SOPs in a clinical operations context.
•Understanding and familiarity of the drug development process.

Special skills/knowledge:

•Results and goals oriented.
• Experience with recruiting, hiring and managing clinical operations personnel
•Ability to effectively prioritize.
•Excellent written and oral communication skills.
•Accuracy and attention to detail.
•Excellent cross-functional team participation skills.
•Outstanding problem solving qualities.
•Ability to grasp new technologies.