Director, Clinical Affairs 8/11/2016

ZOLL San Jose, CA

Job Classification
Full Time
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AJE Ref #
San Jose, CA
Job Type


ZOLL San Jose is a division of ZOLL Medical Corporation, an Asahi Kasei Group company. ZOLL Medical develops and markets medical devices and software solutions that help advance emergency care and save lives while increasing clinical and operational efficiencies. ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. The San Jose Division includes products for therapeutic temperature management, circulation, and CPR feedback.

ZOLL has an open position for a Clinical Affairs Director in its San Jose Division. The position

assists in the management of clinical affairs activities and trial for our medical device products in the EU, US and around the world as necessary. Able to execute parallel clinical trials in accordance with Good Clinical Practices, PMDA, FDA or other regulations. Uses depth and breadth of experience and knowledge of cardiovascular medicine as well as relationship network to advance successful medical devices to market. Assists in the management of clinical affairs employees, consultants, external services providers and clinical trial sites.

Essential Functions:

Project Management:

* Provide overall management for clinical trials as assigned

* Manage all aspects of trial budgets, costs, and site payments

* Ability to participate in business and budget planning as needed

* Experience with originating clinical trial protocols and ancillary documents

* Provide project/study management and monitoring plans for projects in the EU,USand other countries if needed with regard to applicable regulations, guidelines and policies

* Able to tactically execute successful clinical programs and activities

* Skillfully develops, nurtures and maintains relationships with investigators, coordinators, site staff and all members of ZOLL with whom this individual works

* Ensure conformance with GCP, ISO, MDD, CFR and other regulations as necessary

* Lead subordinates by developing,communicating,and building consensus for goals and programs that support division and company objectives

* Investigate and solve problems that impact work processes and personnel in multiple departments

* Ability to develop presentation materials and make presentations to senior staff and company as necessary

* Oversee proper collection of data and participate in the development and maintenance of computerized data collection system

* Oversee Steering Committee and DSMB/DMC meetings and provide presentation content Able to brief management or customers on trial results or status

* Assist with the planning,preparationand presentations at Investigator Meetings

* Assist with determining study objectives, strategy, and scheduling in order to meet business objective

* Assists in the creation and implementation of immediate and long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions in a timely and efficient manner

* Able to simultaneously balance multiplebusiness, clinical, product and physician requirements

* Evaluate performance and assist in career development planning for subordinates

Study Related Material Development and Review

* Manage and contribute to the development of all clinical affairs documents (protocols, IBs, etc.) required in the EU and other countries as assigned

* Manage casereportform development and approval if necessary

* Ensure timely completion of case report forms and queries at clinical centers within timelines determined by Clinical Director

* Prepare, review and approve monitoring plans and reports

* Prepare & approve final study documents such as study manuals, worksheets, etc.

* Manage protocol and investigator brochure development

* Fluent in spoken and written English

Site/CRO/Investigator Management

* Assist with Investigator and site selection

* Perform and oversee site qualification, activation and close-out activities and reports as necessary

* Conducts regular site visits and meetings

* Ensures protocol adherence at all clinical centers in order to maintain a high level of compliance, data integrity and the highest possible percentage of patient follow-up

* Oversee EC/IRB submissions and renewals as necessary

* Oversee site contracts, paymentschedulesand payments

* Lead and perform clinical monitoring activities as needed to ensure compliance with the investigational protocol, good clinicalpracticesand appropriate regulations

* Lead activities performed by Contract Research Organizations (i.e. CROs, core labs) as necessary

* Conduct audits of CROs and other outside vendors as necessary

Training/Scientific Meetings/Other Duties as Assigned

* Assist with site initiation training of investigators, coordinators and other hospital/clinical center staff in order to properly prepare sites throughout the clinical trial to assure correct implementation of study protocols, data collection and superior data quality and integrity

* Manage training of CRAs, Consultants, and Contract CRAs as necessary

* Participate in the development, review and approval of departmental SOPs

* Attend relevant scientific/medical meetings as needed

* Responsible for other duties and projects as assigned

General Departmental Responsibilities

* Confers with Senior Director, Clinical Affairs and other management staff regularly to review internal progress and external conditions and discuss required changes in goals or objectives resulting from current status and conditions

* Comply with ZOLL Circulation's quality system requirements as well as any applicable regulatory requirements

* Maintain up-to-date knowledge of global medical device regulations

* Interact with equivalent levelintra- and inter-organizational management and staff concerning matters of significance to the company

Required Experience

Education/Training/Experience Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


* Must have relevant experience developing and executing clinical programs for Class III cardiovascular medical devices, particularly interventional cardiology or ICU-based clinical trials.

* Prefer MD orPhD. Minimum requirement: BS degree in life sciences plus 10 years of related work experience, or equivalent combination of education and experience

* Prior people management and clinical trial project management experience required

* Fluent in both written and spoken English

Preferred Experience:

Experience leading trials under ISO 14155:2011.

Job Location

San Jose, California, United States

Position Type