Associate Director, Clinical Operations
Lead the planning, execution and completion of assigned regional/global clinical studies, ensuring alignment of activities with study timelines, budgets, SOPs, GCP, ICH and applicable regulatory guidelines, as well as compliance with assigned protocols. Serve as clinical operations leader for assigned project(s) in driving cross-functional team(s) to execute on regional/global clinical studies by partnering and collaborating with internal and external team members. Provide direction for Clinical Operations staff as well as contractors/vendors/CROs involved with applicable studies. Reports to the Sr. Director, Clinical Operations with a dotted-line to the Sr. VP Clinical Operations.
- Responsible for managing the direction, planning, execution, conduct, and summarization of assigned clinical operations project(s), while ensuring compliance with FDA regulations, GCP, ICH, regional/global regulations and Company SOPs for assigned clinical operations activities.
- Support content reviews with regulatory filings and inspection activities.
- Provide guidance and training for the Clinical Operations team, which may include Managers, CRAs and Assistants.
- Responsible for vendor selection and identification, as well as assignment of personnel to participate in the monitoring of all aspects of clinical trial conduct (CRO management and oversight, contract CRAs and consulting staff, etc.).
- Plan, oversee and participate in investigator/scientific/safety/data advisory board meetings.
- Interact with key opinion leaders and therapeutic area experts and study staff.
- Contribute to study design and implementation of clinical protocols, data collection systems, and final reports.
- Assist in the development and management of strategic development plans.
- Establish, track and report appropriate performance metrics. Utilize metrics to manage continual improvement of the project.
- Manage and interact with senior leadership in regards to the project budgets and Investigators'/Vendor grants and contracts.
- Assist in departmental infrastructure improvements/development efforts (e.g., SOP creation/revisions)
- Assist in ClinicalTrials.gov or other registry content preparation and review for assigned projects.
- At least 10 years of experience managing clinical studies and clinical programs in a pharmaceutical or biotechnological environment with work history demonstrating progressive increase in level and breadth of responsibility. A combination of relevant education and applicable job experience may be considered.
- Proven experience leading project activities through collaboration with internal or external providers.
- Extensive and proven experience driving operational activities to achieve timelines, cost and quality.
- Excellent verbal, written, interpersonal skills and ability to lead multifunctional teams.
- Manage and mentor junior staff, as needed.
- Strong knowledge of pharmaceutical clinical development.
- Excellent negotiation and conflict management skills; ability to influence change and process improvements internally and with external study personnel
- Expertise in GCP, FDA and ICH requirements.
- Proficient computer skills, including Microsoft Office Suite/Microsoft Project.
- Ability to travel domestically and internationally up to 20% as required by the program
- Preferred Qualifications
- Advanced degree in a medical or scientific discipline or equivalent experience
- IND, NDA, MAA, or BLA experience
- Therapeutic knowledge of Infectious Diseases
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an E-Verify Company