DIRECTOR CLINICAL OPERATIONS DPS

Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.
nj.
om/.
  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.
epuysynthes.
om.  We are currently seeking a Director – Clinical Operations to support & enhance the clinical research operations of the entire franchise of DePuy Synthes including Trauma, Spine, Total Joints, Sports Medicine, & Early Intervention.  This role will work a Hybrid/Flex schedule and must be based within a commutable distance of Johnson & Johnson offices in Raritan or New Brunswick, NJ, West Chester, PA, Palm Beach Gardens, FL, Raynham, MA or Warsaw, IN.  Relocation assistance is available to qualified candidates.  This role is responsible for the execution of company sponsored studies across the Franchise, ensuring they are conducted in compliance to all applicable regulations and standards, are on-time and within budget.  This leader leads a team of Clinical Operations associates and is responsible for the management of all vendors involved in study execution.  Taking an outside-in approach, this leader takes a key role in understanding the fast-evolving landscape of innovative methodologies for clinical operations, translating their applicability to the Franchise, and more broadly across J&J MedTech with the intent to reduce costs and time.  This role leads / participates in the selection and implementation of new systems and tools for clinical operations.  Primary Responsibilities.
·       In close collaboration with Clinical Affairs Leaders, identifies and ensures global clinical strategies, resources and accountabilities are in place to achieve rapid, cost- effective and well executed clinical studies, for the supported franchises delivering high quality clinical data to support Regulatory, Market Access, Reimbursement and Market Adoption needs.
·       Responsible to deliver clinical studies within clinical / surgical research setting, on time, within budget and in compliance to SOPs, all applicable regulations, and requirements.
·       Management of all clinical operations activities for assigned franchises, coordinating with EMEA, ASPAC and LATAM leaders to ensure appropriate resources, timelines and budget are in place for regional sites/activities.
·       Oversee project timelines and budgets, collaborating with platform / regional representatives.
·       Allocate resources according to budget and timeline requirements maintaining optimal efficiency and cost effectiveness.
·       Provide internal communication to key stakeholders of important clinical data and events (inc.
·       escalation of compliance issues and status reports) and project updates.
·       Develop innovative solutions for complex problems, risk management strategies, and resource allocation.
·       Leads management of vendors (CRO, Central lab, etc.).
·       Ensure regulatory inspection preparation and readiness.
·       Lead in the exploration of new trends in clinical operations innovation to enable modern approaches which optimize opportunities whilst minimizing escalating clinical research costs and reducing time, for example, decentralized clinical trial, e-consent, etc.
·       Assess the value of relevant new methods, systems / tools in addressing clinical operations needs, and present the business case for implementation and adoption when appropriate.
·       Responsible for the recruitment, training, performance management and development of clinical operations and other applicable study support staff.
·       Ensure efficient use of resources to provide high quality deliverables.
Qualifications ·       Minimum of a Bachelor’s Degree required; Advanced degree highly desired with strongest preference for PhD or Pharm D in a related scientific field.
·       Minimum of 10+ years of experience in clinical research/development/operations function ·       Minimum of 2 years of Medical Device sector experience is highly preferred ·       Minimum of 5+ years people management experience including Manager level FTEs is required.
·       Ability to develop and execute change management initiatives around culture & technology.
·       Strong knowledge of emerging technologies within the Clinical Research space.  ·       Strong track record in the oversight of company sponsored studies.
·       Deep knowledge of clinical evidence generation innovations and translation their applicability to the Franchise.
·       Deep and extensive knowledge in all relevant regulations, standards and guidance’s regarding the development, execution and dissemination of clinical data, including ICH-GCP, ISO, FDA 21 CFR Part 812, etc.
·       Ability to travel up to 30% both domestic & international as needed for the role.
The base pay range for this position is $ to $ based on experience.         This job posting is anticipated to close on .
 The Company may however extend this time-        period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept        additional applications.
  The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.     Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, long term incentive, disability plan, 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.
areers.
nj.
om/employee-benefits        Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants           will receive consideration for employment without regard to race, color, religion, sex, sexual      orientation, gender identity, age, national origin, or protected veteran status and will not be      discriminated against on the basis of disability.   #LI-RP1