Associate Director, Medical Affairs and Clinical
The Biosurgery platform in The Ethicon Franchise,a member of Johnson & Johnson's Family of Companies, is recruiting foran Associate Director, Medical Affairs & Clinical located inSomerville, NJ, West Chester, PA, Warsaw, IN, Cincinnati, OH, or Raynham, MA.
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Operating on behalf of the Ethicon MCP platform, this individual will provide scientific and technical information to NeuWave Medical's key customers. They will initiate and maintain relationships to increase awareness of company's products by designing, developing and delivering effective presentations and by coordinating symposia and continuing education seminars. Additionally, they will lead a team of clinical research professionals to support the development of evidence generation / dissemination strategies (EGS/EDS) for multiple and / or complex projects for the NeuWave platform.
- Responsible for Medical Affairs and Clinical R&D activities for multiple and / or complex projects, including:
- Works independently with key thought leaders and academic institution to advocate the responsible use of innovative therapies.
- Discusses Investigator initiated study concepts with clinicians.
- Builds and maintains supportive relationships with key opinion leaders on clinical application of company's products.
- Plans and organizes continuing educational workshops, seminars, programs and advisory boards (clinical discussion & debating forums) for physicians, pharmacists and scientists.
- Evaluates analysis of clinical studies to ensure information integrity of the company's products. Issues analysis report for management use.
- Leads key product presentations to demonstrate the benefits to thought leaders, medical groups, government agencies and health systems.
- Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections;
- Lead team of clinical research professionals to develop and deliver appropriate Global EGS / EDS to support New Product Development and Life-Cycle Management (NPD & LCM) within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc.), ensuring cross- functional alignment;
- Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP);
- Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS;
- Support the design of appropriate clinical trials to meet the NPD / LCM needs;
- Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including CSRs, abstracts, manuscripts, etc.
- Responsible for team's interface and collaboration with key opinion leaders, investigators, IRB's/EC's, Regulatory Agencies, societies, associations, etc.
- Foster strong relationships with external stakeholders to shape and influence relevant policies, etc.
- Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement.
Functional and Technical Competencies:
- Expertise in clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
- Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders;
- Ability to lead a team of clinical scientists to provide strategic and scientific clinical research input across NPD and LCM projects;
- Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;
- Comprehensive understanding of clinical trial regulations across multiple regions;
- Ability to lead teams to deliver critical milestones;
- Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives;
- Leadership requirement - ability to influence, shape and lead without direct reporting authority;
- Change agent in team progression;
- Experience in effective management of project budget processes;
- Through transparent leadership, be a key leader in developing a high-performing team with a global culture;
Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, Deliver as noted below.
- Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS
- Shape - build strong relationships with external stakeholders to shape and influence relevant policies
- Lead - develop talent to provide strategic and scientific clinical research capability, including responsibility for professional development of direct reports
- Deliver - ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Performs other related duties as required.
- A minimum of a Bachelor's degree in Biological Science or a related discipline is required. An advanced degree (Masters or PhD) is preferred.
- A minimum of 8 years of related experience within Clinical Research or Medical Affairs function is required
- Experience working in Oncology Therapeutic Area is required
- At least 2 years of people management-related experience is preferred for this role.
- A minimum of 2 years' experience interacting with customers in a medical or clinical atmosphere is required
- Experience managing Investigator Initiated Studies is required
- This position will be located in located inSomerville, NJ, West Chester, PA, Warsaw, IN, Cincinnati, OH, or Raynham, MA, and may require up to 50% travel (domestic and international)
United States-New Jersey-Somerville
North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-Massachusetts-Raynham
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD
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