Head of Clinical Affairs - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 6/18/2018

Job Snapshot

  • Employee Type:
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

The Head of Clinical Affairs will be responsible for the overall Clinical Operations management, development and execution of department functions including: human clinical study designs, conduct and monitoring, data collection and report development, outsourcing, vendor management, and related actions in compliance with applicable rules, regulations and laws. These clinical trial activities are required to support regulatory submissions and product registrations, as well as post-market clinical trials.

  • Provides strategic direction regarding the evaluation, design, resource allocation and execution of physician-initiated investigations (Investigator Initiated Studies). Clinical Operations is the administrator of the IIS Committee activities to review, document, implement and track all Getinge IIS proposals.
  • Provides management and oversight of activities by Clinical Operations to support the risk benefit analyses as part of the Quality System, product lifecycle and Risk Management requirements. As required, responsible author of clinical literature evaluation reports (e.g., Clinical Risk Benefit Analysis – CRBAs, Clinical Evaluation Reports – CERs, Overall Risk Benefit Analyses – ORBAs).
  • Member of the Quality Management Review Committees/Teams representing Clinical Affairs with responsibility assigned according to the Management Review SOPs; responsible as Clinical Affairs sign-off of related Quality Management System Controlled Documents.
  • Interfaces and collaborates with Regulatory Department as necessary to develop responses to Health Authority (e.g., FDA) and Notified Body queries, requests for information, submissions in support of ongoing Getinge product registrations and CE marking requirements.
  • Reviews and approves study documentation for clinical programs including: protocols, statistical and data analysis plans, monitoring plans, informed consent forms, case report forms, investigator agreements and financial agreements, as required. 
  • Implements and updates departmental Standard Operating Procedures to support adherence to company policies and procedures, cGCP and related regulatory processes. Participates in or leads quality improvement efforts to increase overall operational efficiency of the clinical operations team. Will ensure the most recent ICH-GCP requirements for Risk Based Quality Management Systems are implemented within the Clinical Operations processes, as required.
  • Continues to increase knowledge of medical device development processes and standards set forth in FDA regulations, ICH-GCP guidelines, ISO, MEDDEV guidelines, and any other applicable local/international regulatory requirements.
  • Interfaces with Medical Affairs, Legal, R&D, Regulatory, and Marketing to ensure that clinical activities are in line with overall product development goals.  Participates in cross-functional meetings. Provides clinical updates and strategy considerations to Chief Strategic Officer, Chief Technology Officer and other senior management members, as required.
  • Directs data collection, analyses and communication of clinical research results, in accordance with applicable regulations, and in support of strategic business and/or regulatory goals.
  • Hires, develops, trains, mentors and retains senior clinical operations staff, study managers and contractors who demonstrate a high level of professionalism, excellence and competency.
  • Responsible for financial management oversight of department and clinical trial program budgets, contract negotiations and budgets with clinical study sites and vendors. Provides proactive management of resource allocation, personnel and budgets.
  • Oversees work with external vendors, IS/IT/Training platforms to develop Clinical systems and tools that promote compliant, expedient data collection, analyses, reporting and deliverables.  Seeking e-tools to promote transparency and accountability for all clinical programs (e.g. Executive Dashboard).
  • Ensures that all Clinical Operations staff and vendors have adequate GCP training. Ensures Clinical team compliance with requirements for corporate training and continuing education.
  • Anticipates/identifies potential problems and implements corrective actions as required for clinical study activities. Ensure audit readiness at all times (Sponsor and Investigational Study Sites). Participates in internal/external study-related audits, as required.
  • Represents Getinge and the ACT Team at conferences, regulatory meetings, and relevant society meetings and trade associations.

Required Knowledge, Skills and Abilities: Soft skills and technical requirements to be listed here.

  • Demonstrated experience to effectively manage projects, independently solve problems and deliver high quality, compliant clinical research results.
  • Leadership skills to effectively communicate vision, strategy and goals; leading and inspiring others to support and achieve the aligned goals.
  • Successful track record for hiring, managing and developing clinical research professionals.
  • Experienced in collaboration and effective interface at the senior management level.
  • Strength in analytical, interpersonal and organizational skills. Attention to detail and ability to multi-task in a fast-paced environment.

Minimum Requirements:  minimum requirements for the position.

  • Master’s Degree (or equivalent) in Medicine, Health, Life Sciences, Regulatory, Organizational Management or related discipline.
  • Fifteen years or more of relevant clinical research experience and/or combination of education and related experience is necessary.
  • Proven track record in design and development of human clinical research projects including: protocols, clinical investigational plans, regulatory strategies and clinical study report compilation for regulatory submissions.
  • Practical knowledge of FDA guidelines and local regulations concerning clinical research, ICH guidelines, Good Clinical Practices (GCP), and other related Standards governing the conduct of medical device clinical trials.
  • Experienced in scientific literature searches, retrieval and evaluation.
  • Experienced in the use of electronic data collection & managements systems.
  • Experienced leader of clinical research / operations teams in the medical device, pharmaceutical or biotech industry.
  • Proficiency in MS Office applications (Word, Excel, Outlook, PowerPoint).

GETINGE Company the position is with:

MAQUET Medical Systems USA

MAQUET is an equal opportunity employer M/F/Veteran/Disability

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status




We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.