Manager, Clinical Programs

The Manager, Clinical Programs (MCP), is responsible for the execution of a suite of clinical trials and provides leadership and manages the study managers who drive trial execution. Responsibilities include creating timelines with cross functional teams, study document creation, start up and study close out. Will work with a wide variety of vendors. A MCP mentors the study managers while they coordinate across other functional groups that comprise the clinical department; specifically, statistics, clinical monitoring, data management, medical writing, medical and safety to insure proper conduct and timely completion of all projects. This role ensures consistency on the execution of trials throughout the department. We are currently considering candidates located near a major airport in the following states: CA, TX, PA, NJ, GA, IL, WI, MI, TN, OH, MA, IN.

Responsible and accountable for global clinical studies as part of a therapeutic program, inclusive of strategy.

Develops strong and collaborative working relationships with Key Opinion Leaders.

Hire, train and mentor study managers to develop project plans inclusive of database planning, enrollment projection, site ramp up through database lock and trial completion.  Manage all aspects proactively.

Develops staffing plans for onboarding and continuing career growth.

Oversees the timelines of data snapshots for study reports, DSMB and CEC meetings and FDA submissions.

Responsible for overseeing MS Project timelines for each project, and uses these timelines to track and manage a project's progress.  Ensures resources are available across projects.

Reviews and approves Penumbra marketing materials.

Participates in cross functional strategy plans with internal (Regulatory Affairs, Marketing, Reimbursement, R&D) and external (Key Opinion Leaders, Study Investigators, etc.) stakeholders to draft global clinical strategies. 

Reviews and/or writes protocols and assists in CRFs development.

Manages and oversees data review, participates in safety review.

Collaborates with Medical Affairs and Marketing for clinical podium publications and presentations as needed globally.

Proactively looks for process improvements opportunities in the department and implements them.

Leads team in vendor selection and ensures strong relationships with those vendors (e.g. Core Lab, EDC, and CROs).

Participates in internal/external audit as the subject matter expert.

Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.

Ensure other members of the department follow the QMS, regulations, standards and procedures.

Perform other work-related duties as assigned.

BA/BS/RN/BSN or equivalent is preferred with 8+ years of biotech clinical research experience, or an equivalent combination of education and experience 

Additional qualifications:     

Highly effective organizational and communication skills

Previous Field monitoring experience highly desirable

Previous FDA or other regulatory body trial design experience preferred 

Knowledge of CFR and GCP/ICH requirements is required

Demonstrated leadership skills and the ability to solve problems proactively 

Proficiency with Excel, MS Project, Contract development and vendor oversight. CRO management experience a plus

Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company 

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

A collaborative teamwork environment where learning is constant and performance is rewarded

The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases

A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan

 

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

If you reside in the State of California, please also refer to  Penumbra's Privacy Notice for California Residents .

For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP-Policy-Statement.