Director, Clinical Operations
Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Director, Clinical Operations
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Oversees the conduct of all clinical trials.
- Facilitates confidentiality agreements, and study agreements with sites and external vendors.
- Develops and actively manages clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and in collaboration with investigational sites to meet, and whenever feasible, exceed enrollment targets.
- Spearheads the writing/reviewing/approving clinical project deliverables such as investigational product labeling, pharmacy manuals, informed consents, IRB submissions/approvals, site activations, CRFs, DMP, edit checks, safety plan, DMC charter, and close-out plans.
- Assists in identifying and evaluating investigators and investigative clinical trial sites.
- Oversees and executes the completion of clinical trial feasibility studies.
- Implements all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
- Coordinates Institutional Review Board/Ethics Committee (IRB/EC) approvals, as appropriate.
- Oversees the clinical trial monitoring activities in accordance with company and ICH/GCP standards and in compliance with the approved monitoring plan and SOPs.
- Provides oversight of all Contract Research Organizations (CROs) and ensures that all sites and CROs are audit ready.
- Maintains the Clinical Trial Master File together with development partners and/or CROs for all company Clinical programs, ensuring accuracy and completeness of the documentation.
- Manages study milestones and study metrics.
- Provides regular study updates and trial status to the Vice President, Clinical Science Operations.
- A Bachelors’ Degree is required¸ preferably in a Scientific or Technical Discipline.
- Advanced degree (MS, RN, PhD or PharmD) is highly preferred.
- Must have a minimum of 10 years of experience in the Clinical Research & Development/Clinical Trials environment.
- Clinical trial monitoring experience required.
- Requires the ability to travel up to 20% of the time both domestically and internationally.
- Must have a complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP).
- Familiarity with gene and/or cell therapy is highly preferred.
- Experience with all phases of clinical drug development including global regulatory submissions is highly preferred.
- Strong communication, organizational and interpersonal skills are required.
- Requires successful work experience in a matrix team environment with cross functional teams.
- The ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities is required.
If interested, please email your resume as a Word attachment to us. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.