Director, Clinical Operations
Our client is a biotechnology company. They have asked us to assist them in a search for a Director, Clinical Operations.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Holds responsibility for the scientific, clinical, and operational implementation and execution of key clinical studies.
- Manages all aspects of study progress from planning to closing to assure the adherence to intended timelines and achievement of study goals, as well as ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
- Oversees clinical project budgets, expenditures, and payments for multiple studies.
- Authors and reviews clinical study protocols, informed consent forms, clinical study reports, and other clinical documents as necessary.
- Participates in the preparation of regulatory filings as needed.
- Partners with CMC and clinical supplies to provide product supply assumptions for clinical trials.
- Coordinates activities with contract research organizations and other contractors to ensure successful clinical trial implementation and execution.
- Develops timelines for each study to meet clinical development and project management goals.
- Establishes and maintains good working relationships with clinical study sites.
- Supervises clinical operations staff with the responsibility of hiring, conducting performance reviews, and overseeing salary decisions and performance issues.
- Leads, plans, and executes clinical Investigator meetings, study meetings, and vendor meetings as needed.
- Attends scientific conferences as needed.
- Ensure execution of activities outlined in various study plans.
- A Bachelor’s degree or Master’s degree in a medical, health, or science related area with 12+ years of clinical research experience (preferably oncology) and 5+ years of managing people and leading a team is required.
- Must have thorough knowledge of clinical research concepts, practices, and FDA regulations regarding clinical research trials.
- Adequate knowledge of clinical trial design, familiarity with data processing methods, satisfactory knowledge of clinical medicine and terminology and a broad knowledge of a drug development organization is required.
- Requires excellent demonstrated managerial skills and strong interpersonal skills in interacting with clinical monitors, physician investigators, and various individuals in specialized areas and internal groups to facilitate clinical trial research.
- Must have effective leadership and development skills.
- Proven experience in negotiating, influencing, and problem solving in order to meet study timelines is required.
- Must maintain familiarity with therapeutic areas via independent study and by attending scientific meetings and workshops.
- Requires excellent verbal and written communication skills, the ability to work independently and with a team, and good planning and organizational skills.
- Must be able to exercise judgment within broadly defined criteria for obtaining results.
- Must have proven experience in management of CROs, multiple vendors, and complex protocols.
- The ability to travel up to 30% of the time is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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