Description

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

The Clinical Affairs Leader plays a pivotal role in orchestrating the development, execution, and communication of clinical evidence strategies aimed at facilitating market registration, enhancing access, and fostering adoption within their designated platform within the Platform portfolio.

As the voice of clinical evidence, this position contributes strategic insights to shape the strategic input into the platform innovation agenda and participates on the Platform Leadership Team. This role leads the Platform Clinical Affairs team.

Key responsibilities will include:

· Provide an objective and robust assessment of clinical evidence requirements, opportunities, and risks across all key markets to inform the platform innovation agenda.

· Shape and influence relevant external policies, regulations and guidance related to clinical evidence requirements.

· Drive exploration of current trends in data-collection (Real World Data, Predictive Analytics) that enable innovative evidence generation approaches which optimize evidence generation opportunities whilst minimizing escalating clinical research costs.

· Lead the team of clinical scientists in the development and execution of evidence generation and dissemination strategies that meet the needs of all key stakeholders to enable market authorization, access, and adoption.

· Deliver pre- and post-market Clinical Development Plans, describing the plans for clinical investigations, clinical evaluations including post-market clinical follow-up as per region specific requirements (US, EU, China, Japan and other key and prioritized markets)

· Deliver clinical programs, working in partnership with Medical Affairs / Safety, Clinical and Medical Operations and Biostatistics & Data Management (BSDM)

· Lead the dissemination of clinical evidence (clinical study reports, clinical evaluation reports, clinical content of regulatory submissions, abstracts, manuscripts, etc.

· Lead clinical scientific discussions with regulatory agencies and notified bodies to drive appropriate evidence strategies.

· Provide support for external regulatory inspections and audits, and internal audits.

· Lead, mentor and coach a team of Clinical Affairs scientists.

· Develop key talent with critical scientific thinking to drive innovative clinical evidence plans.

· Align strategy, budget, and resource allocation in close partnership with the cross-functional and regional partners including R&D, Regulatory, Marketing and Health Economics and Market Access (HEMA)

· Responsible for the Clinical Affairs platform business plan

Qualifications

Requirements:

· PhD, DPharm or Masters in relevant scientific subject

· A minimum of 12 years of experience in clinical research / development function, or related functional area, preferably in the development of medical devices.

· Proven ability to build and lead a team of scientists to provide strategic and scientific clinical research input from concept through new product development projects, and life cycle management.

· Experience in areas of highly complex clinical evidence risks enabling informed business decisions.

· Proven track record in successfully developing and executing complex clinical evidence strategies that enable market registration, access, and adoption.

· Deep and extensive knowledge in all relevant regulations, standards and guidance regarding the development, execution, and dissemination of clinical data, including ICH-GCP, ISO14155, FDA 21 CFR Part 812, etc.

· Experience in evidence dissemination is required, including support of global regulatory submissions for medical devices, biologics, or drugs, and scientific abstracts, manuscripts, etc.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits