Clinical Operations Lead
Location: Remote, West Coast
Contact: info@bandishgroup.com
THE ROLE:
Clinical Operations Lead | Clinical Stage Biotechnology Company
DESCRIPTION:
We seek to identify a Clinical Operations Lead for our client who is a Clinical Stage Biotechnology Company in the San Francisco area.
This individual will support US clinical operations activities related to our cellular therapy programs, including the planning, development, and execution of clinical trials, overseeing of CRO partner activities, development of clinical trial documents, and operational/financial forecasting.
They seek a candidate who is experienced in cell therapy drug development in a biotechnology setting.
This is a critical position that will play a key role in establishing and maintaining effective relationships with CRO and cross-functional partners. This individual will also work closely with Head of Clinical Development to develop the long-term global clinical strategy and vision for our client’s cell therapy products in development.
HIGHLIGHTS OF RESPONSIBILITIES:
Build a regulatory team and maintain strong leadership while supporting theprofessional development of new hires.
Develop and implement cross-site department policies, processes and SOPs.
Interact with the FDA and other regulatory agencies to seek scientific and regulatory advice for planned phase 1 studies.
Work on all aspects of planning, creating, publishing, submitting, and archiving of regulatory submissions to health authorities.
Oversee compliance and quality activities.
Lead the implementation, validation, and operation of eCTD and electronic document management systems (e.g. Veeva) and other publishing and submissions technology projects.
Lead the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group.
Manage regulatory budgets and vendors.
Provide regulatory leadership for due diligence activities, partnering activities, etc.
Ensure consistency, completeness, and adherence to standards for all regulatory Submissions.
Ensure inspection readiness efforts for regulatory activities and files.
DESIRED SKILLS AND QUALIFICATIONS:
Bachelor's degree with a minimum of 10+ years of related work experience in the biotech/pharma industry with 5+ years of managerial experience developing and leading a team.
Solid track record in developing cell therapy products. Experience with breakthrough designation, RMAT, orphan designation, etc., is highly desired.
Expert knowledge of regulatory submission publishing standards and procedures, including electronic document management systems and regulatory publishing software.
Robust understanding of evolving Health Authority (HA) standards and procedures for regulatory submissions.
Demonstrated proficiencies in leading successful health meetings and interactions.
Relevant knowledge of CMC, QA, clinical and nonclinical science.
CONTACT:
For additional information about this role, contact a member of our team at 267-483-5233 or info@bandishgroup.com.
The Bandish Group, LLC
Life Sciences Executive Search
Greater Philadelphia Region
www.bandishgroup.com