Director, Clinical Operations & Evidence Generation – MedTech Surgery, Inc

Job title:

Director, Clinical Operations & Evidence Generation – MedTech Surgery, Inc

Company

Johnson & Johnson

Job description

At 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.jnj.comJob Function: R&D OperationsJob Sub Function: Clinical/Medical OperationsJob Category: People LeaderAll Job Posting Locations: Leeds, West Yorkshire, United Kingdom, Mechelen, Antwerp, Belgium, Oberdorf, Basel-Country, SwitzerlandJob Description:We are searching for the best talent for a Director, Clinical Operations & Evidence Generation. This is a remote role available within the United States, Belgium, Switzerland, or the UK. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.Purpose: This role will be accountable and responsible for start-up and execution of clinical affairs data generation efforts including company sponsored studies (CSS), investigator-initiated studies (IIS), collaborative studies, and post marketing commitments for MedTech Surgery. Drive and execute the MedTech Surgery strategic evidence generation plan end-to from ideation to data dissemination.You will be responsible for:

• In close collaboration with Clinical/Medical/HEMA Franchise Leaders, identifies and ensures global 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 and 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.
• Define and administer project timelines and budgets in collaboration with business unit and regional representatives. Allocate resources according to budget and timeline requirements maintaining optimal efficiency and cost effectiveness. Manage all projects to ensure adherence to budget and timeline plan.
• Provide internal communication to key stakeholders of important clinical data and events (inc. escalation of compliance issues and status reports) and project updates.
• Understand business value and balance overall business objectives and functional needs.
• Communicates with and supports management of vendors (CRO, Central lab, etc.), as needed.
• Ensure Regulatory body inspection (including BIMO) preparation and readiness (including study documentation filing and maintenance appropriately and timely).
• Participate in evidence generation reviews, protocol reviews and project core teams as needed and appropriate.
• Develop innovative solutions for complex problems, risk management strategies, and resource allocation. Identify opportunities and lead the implementation of new clinical systems and processes.
• Responsible for the training, performance management, and development of clinical staff. Manage and mentor Principal Clinical Trial Leaders and Clinical Trial Managers, as applicable.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Support Clinical Operations and Clinical Franchise by taking on other tasks, as needed.

Qualifications/Requirements:

• Minimum of a Bachelor’s Degree is required, Advanced degree (PhD in Life Science, PharmD, MD) is strongly preferred; additional business degree (MBA, DBA) is a plus.
• Minimum 10+ years of relevant experience including global clinical team leadership across multiple studies/programs is required, additional Medical Affairs experience highly desired.
• Experience with departmental budget planning, tracking and control is required.
• At least 10 years of experience managing others is required.
• Medical device experience strongly preferred.
• Up to 20% domestic and international travel required.
• Strong skills and demonstrated competencies in the following areas are required:

• Leadership and Mentoring
• Change Management
• Written and Verbal Communications
• Presentation and Influencing
• Clinical project management
• Good Clinical Practice
• Regulations pertaining to conduct of clinical studies
• Relevant industry certifications a plus
• PowerPoint, Excel, Word, Outlook, PowerBI and relevant database experience

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):United States – Requisition Number: R-001756UK/Switzerland/Belgium – Requisition Number: R-006278Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):United States – Requisition Number: R-001756UK/Switzerland/Belgium – Requisition Number: R-006278Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Expected salary

Location

Mechelen, Antwerpen

Job date

Thu, 27 Mar 2025 23:52:21 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnear.net) you saw this job posting.