Director of Clinical Operations
The Director, Clinical Operations will be a key member of Tal’s clinical management team, and will be responsible for overseeing the execution of clinical development activities including protocol development, study site selection and feasibility assessments, interacting with investigators and study staff as needed, ensuring the application of GCPs at study sites, working with CROs or contract staff, and such other duties as may be assigned from time to time under the direction of the Chief Medical Officer.
The candidate must be a self-starter with senior level clinical operations experience, and a proactive leadership oriented mindset. Experience as a clinical scientist and study manager on clinical trials in the CNS area is required. The location for the role is preferred to be in the Boston metro area.
- Lead the clinical operations aspects of the LFMS clinical program
- Engage with current investigators and sites as needed to ensure completion of ongoing studies
- Plan for the execution and management of future clinical studies, including
- Collaborating with the CMO and external experts as needed to finalize the study protocols
- Leading the selection of study sites using feasibility assessments and site visits
- Facilitating and ensuring timely completion of site start-up requirements
- Engaging with CROs to make appropriate selection of services required for the LFMS studies, driving the contracting process, and establishing working arrangements with CRO leads
- Help in the selection of vendors as needed for the clinical programs
- Oversight of vendors and CROs that may be engaged to execute the clinical program
- Ensuring compliance with all regulatory requirements by the study sites and assisting in record-
- keeping and creation of documentation as may be needed during and following completion of the studies, including the writing of research reports, regulatory summaries, etc.
- Scientific qualifications commensurate with leading clinical development of therapeutic modalities (e.g. drugs, devices)
- Led clinical development operations for multiple industry-sponsored multicenter clinical trials
- Proven track record in evaluating, selecting and overseeing study sites
- Ability to effectively oversee and manage outside vendors
- 10+ years relevant professional experience
- Effective proactive leader who is able to operate independently but also take direction as appropriate
- Personal characteristics of integrity, team work, can-do-attitude and personal excellence
Commensurate with qualifications
How to apply: Please submit a CV and a cover letter to firstname.lastname@example.org