The Director/Sr. Director of Clinical Operations and Clinical Development will report directly to PureTech Health's Vice President of Clinical Operations and will interact on a regular basis with the broader executive team. The position's primary responsibility is to assist in the development, implementation, and management of clinical trials for PureTech Health.
Developing, implementing, and/or managing adequate systems and procedures to ensure efficient day-to-day operations that meet PureTech Health and its affiliates' clinical trial needs.
Assisting with clinical trial vendor selection and selection of vendor personnel to meet clinical trial planning, execution and clinical trial obligations for the company. This may include the following personnel from vendors: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, and Medical Writers.
Ensuring compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintaining Clinical Operations training including reviewing training of vendor personnel and external contractors.
In conjunction with VP of Clinical Operations, help to outline the scope of clinical trial programs with resource needs, timelines, and cost of services
Deploying resources, as necessary, for each new project and ensuring that clinical program and trial objectives have been properly communicated to key personnel (e.g., Project Managers, and other functional areas).
Providing oversight and support to Clinical Operations and Project Management areas at CROs to ensure their ability to meet PureTech's clinical, regulatory and business objectives through efficient completion of the tasks delegated to them, including, but not limited to:
Overseeing preparation and review of key documents.
Collaborating in identifying and evaluating potential investigators and other service vendors to perform clinical study work.
Tracking and collaborating on the management of study budgets and contract negotiations with vendors and clinical trial
Facilitating and tracking payments to vendors and clinical trial investigators.
Managing interactions with vendors and clinical trial investigators to ensure vendors and sites meet clinical, regulatory and PureTech Health business objectives.
Ensuring the quality of clinical trial initiation, study execution, conduct and close-out of clinical trial/program.
Coordinating all Clinical Operations activities, resolving trial execution conflicts, and providing status reports as required.
Interfacing with other functional areas to proactively identify and, if possible, resolve issues or delays that could impact timely clinical study completion.
Minimum of a bachelor's degree in a scientific discipline; Master's degree strongly preferred.
Minimum of 5 years of Clinical Operations and Clinical Trial Management experience at a contract research organization, biotech or pharmaceutical company including management of direct reports.
Demonstrated history of responsibility for directing clinical research programs and staff.
Excellent written and oral communication skills.
Excellent organizational skills with ability to multi-task.
Demonstrated ability to effectively procure, manage, and control project resources. Project management training and applied experience a must.
Demonstrated ability to work effectively with representatives from a broad range of scientific disciplines.
Solid understanding of clinical indications and the drug development process.
Working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice.
Good interpersonal skills with a demonstrated record of working in a team-oriented manner.
PureTech is a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders, and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech's affiliates, is comprised of 24 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programs and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company's unique insights into the biology of the brain, immune, and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.
PureTech does not accept agency resumes unless under contract for a particular assignment with approved access to our ATS Portal. Please do not forward resumes to our careers site, employees or any other company location or affiliate of PureTech. PureTech will not be responsible for any fees related to unsolicited resumes.