Sr. Director, Clinical Operations
Responsible for global clinical operations for all clinical trials from pre-clinical to Phase III, including the direction, planning, and execution of clinical trials, project planning, budget, resource management, contract research organization and vendor management, data collection, analysis, and reporting to prepare documentation required for inclusion in the company’s regulatory submissions.
Responsibilities include:
Ensures compliance with good clinical practices and regulatory guidelines.
Develops high quality, integrated cross-functional plans for managing clinical research activities including activities to be performed in-house or through third-party relationships to complete clinical trials according to the strategic plan to support product approvals.
Develops and implements innovative process ideas to impact clinical trials management and applies best practices in the development, initiation, planning, execution, control and closing of clinical studies.
Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
Responsible for clinical budget and development of contingency plans for clinical trials, and for ensuring that clinical projects adhere to budget, scope and schedule requirements.
Responsible for adherence to protocols by clinical sites and contract research organizations.
Ensures that compliant processes are in place for distribution of clinical inventory to investigational sites.
Interacts with finance, research and development, marketing, manufacturing, regulatory and other relevant departments as appropriate within the company and externally with investigational sites, clinical consultants, contract research organizations and other vendors.
Manages and coordinates clinical budget and related pricing strategy services for the purpose of executing clinical trials or ancillary services agreements.
Ensures coordination of the activities of functional groups that comprise the clinical department team for the product including, but not limited to: clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to ensure proper conduct and timely completion of all clinical studies.
Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Oversees and develops the strategic planning and direction of patient recruitment efforts and feasibility of clinical studies in one or more therapeutic areas.
Manages feasibility protocol assessments, site identification, study projection scenarios and vendor evaluation.
Identifies potential recruitment barriers, regional recruitment boundaries, contingency plans and implementation plans by country and site.
Education and Experience Requirements:
BS, BSc, MS, MSc in science or healthcare preferred or equivalent relevant experience.
At least 10 years in Clinical Operations within the biotech or pharma industry, with at least 5 years in oncology.
Management of Phase 1 through Phase 3 clinical trials with complex sample collection, including tissue biopsies and blood samples for cytokines, pharmacokinetics, pharmacodynamics markers, and RNA analysis.
Demonstrated excellence in selection and management of CROs and other study related vendors.
Demonstrated ability to hire, lead and inspire teams of clinical operations professionals and to collaborate with interdisciplinary teams to accomplish clinical and corporate goals.
Other Requirements:
Enthusiastic, passionate about bringing important new therapies to patients with cancer, and willing to roll up his or her sleeves to do whatever it takes while building the right team of outstanding clinical operations professionals.
Team player with outstanding communication skills.
Preferred Experience:
Immuno-oncology
Companion diagnostics
To be considered for this role, please submit your resume to Careers@JounceTx.com with the job title in the subject line of your email.
We are an equal opportunity employer offering a competitive salary and benefits package.
All applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.