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Sr Manager, Clinical Research and Post-Mkt Strategy.US-HOM.001

Employer
Integra LifeSciences
Location
Princeton, NJ
Closing date
Dec 13, 2021

View more

Sector
Other
Organization Type
Corporate
Overview:

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours.

At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success.

Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.

Regardless of geographic location, our commitment is to offer the following, whenever possible:

Benefit plans that meet all local statutory requirements

A range of programs that reflect typical local market practices

An opportunity for employees to tailor benefits to their specific needs

Benefits that balance employee's short-term and long-term needs

Click for more information regarding our benefits and total rewards program

Responsibilities:

SUMMARY DESCRIPTION

Reporting into the Senior Director, Clinical Operations, the Senior Manager, Clinical Research and PMCF Strategy will work proactively and collaboratively with cross-functional colleagues to support the planning, development, and scheduling of all aspects of Post-Market Clinical Follow-Up (PMCF) Plans to enable product development and commercialization. They will be a key intermediary between Clinical Operations, Regulatory Affairs, Medical Communication and Information, Medical Affairs, and Marketing to understand PMCF Plan needs, especially as related to regulatory and commercial requirements, to design executable PMCF Plans which support products' IFU. Further, this individual will liaise with and oversee work provided by external contract research organizations (CROs) who support planning and conduct of aspects of the PMCF Plans. By fulfilling these responsibilities, the individual will assure the effective design and conduct of PMCF Plans which support regulatory submissions and generation of clinical evidence for the company's products. Additionally, they will work proactively and collaboratively with other Clinical Operations colleagues to ensure the successful planning, resourcing, delivery, and communication of the entire portfolio of clinical studies.

PMCF Plan Development and Execution:

Lead the gathering and evaluation of existing clinical evidence to form a foundation for decision making in PMCF Planning. Opinions should be formulated with internal (e.g. Medical Communication and Information, Regulatory Affairs) and external (e.g. contract research organizations (CROs)) subject matter experts (SMEs).

Oversee the review and cataloguing of documents related to PMCF Plan design including study synopses, clinical evaluation reports, technical files, design dossiers, and internal and external literature to ensure robust planning.

Synthesize available information and gaps in information about products to understand needs for PMCF Plan development and execution as it relates to scientific, regulatory, and commercial goals. Activities must be coordinated with internal stakeholders such as Regulatory Affairs, Medical Communication and Information, and Marketing.

Lead development of PMCF study synopses (e.g. surveys, registries, single-arm studies, etc.) that will fulfil clinical evidence requirements leveraging internal and external SMEs, as applicable. Define scope (e.g. number of patients required), cost (including breakdown of cost over time), and timing for conduct of said clinical study to be incorporated into wider project portfolio and budget.

Develop recommendations on feasibility of a PMCF project and Return On Investment (ROI) for communication to internal stakeholders involved in the decision-making process.

Create alignment between key stakeholders such as Marketing (e.g. ROI), Clinical Operations (e.g. resource availability and planning), Medical Affairs (e.g. applicability of endpoints), and Regulatory (e.g. fulfilment of CE registration requirements) on proposed study synopsis so that additional PMCF Plan development can be initiated.

Oversee development of full PMCF Plans according to all applicable GSOPs and current best practices for incorporation into the product's technical file.

Incorporate study activities related to approved PMCF Plans into overall schedule of clinical research projects.

Inform the decision on staffing of approved projects (e.g. insourcing versus outsourcing). Ensure availability and assignment of appropriate human resource support for clinical research projects, requesting additional resources as required.

Ensure financial support for conduct of clinical research projects and incorporate into appropriate budgetary tools and financial systems, ensuring appropriate timing and phasing of required funds

Oversee the successful execution of PMCF Plans and related clinical research projects as assigned in conjunction with CROs and/or the Clinical Operations department.

Ensure compliance with all external reporting requirements (e.g. ) for PMCF studies.

Oversee development of annual and final PMCF study reports for submission to appropriate notified bodies. Ensure appropriate reporting of results in compliance with external requirements.

Portfolio Management for Clinical Projects:

Ensure reported all clinical project plans are anchored on standard Key Performance Indicators (KPIs) and entered in appropriate business systems (e.g. GenSight).

Generate resource models reflective of approved clinical project plans and validate those models with appropriate stakeholders (e.g. Clinical Operations Management, Clinical Research Managers). Ensure reported plans can be utilized for activities such as resource planning and gap analysis.

Communicate portfolio, project, and resource status and requirements to stakeholders (e.g. CSO leadership, divisions, Executive Leadership Team).

Coordinate within the Global Program Management (Office of the CSO) for the preparation and update of key project documents and systems (e.g. GenSight) to reflect Clinical Operations strategic and operational plans.

Cross-Functional Team Support:

Prepare PMCF Planning documents supplied to regulatory bodies, both national and international, in support of product licensure and certifications.

Liaise with the cross-functional team to ensure that product-specific information is considered and incorporated into PMCF Plan design.

Provide routine updates to relevant and affected parties within the organization focusing on execution and budget management.

Act as a subject matter expert for the clinical components of medical device regulations in the United States and internationally with a focus on FDA Code of Federal Regulations and EU Medical Device Regulations.

Coordination, Communication, and Administration:

Lead or participate in quality and continuous improvement efforts to increase overall effectiveness of the Clinical Operations team.

Interface with other departments (Quality, Legal, Regulatory, R&D) to represent the clinical department and ensure effective inter-department communication and collaboration.

Represent the company at conferences, regulatory meetings, and relevant trade associations.

Accurately complete administrative activities such as time reporting and expense reporting in a timely and accurate manner.

Complete other assignments and responsibilities as required.

Qualifications:

Master's degree or equivalent experience in LifeSciences, Pharmaceutical, or related field is required. In lieu of a master's degree, a bachelor's degree with 10 years of experience designing and overseeing clinical trials may suffice.

Specific competencies

In-depth knowledge of clinical research guidelines and industry standards for conducting Medical Device (e.g. Class III) clinical studies. Experience with OUS clinical studies is preferred.

Strong scientific background with experience in trial design or epidemiological experience with an advanced understanding of medical and/or clinical terminology

Direct experience managing clinical research studies / post approval studies through the following stages: concept development, clinical study design, clinical study activation and execution, clinical study reporting, and publication strategy.

Direct experience building cross-functional Project Plans (i.e., Base, Accelerated, and Worst-case scenarios), and executing against established plans and financial commitments.

Experience managing vendors from the RFI, RFP, through vendor certification process.

Experience with statistics or biostatistics and interpretation of clinical trial data.

Experience drafting reports for federal and/or international regulatory bodies.

Demonstrated ability to effectively interact with and collaborate at all levels in the organization and with external stakeholders, including effective interfaces at the senior management level.

Strong interpersonal skills and the ability to form strong and constructive internal as well as external professional relationships.

Strong verbal and written communication skills, including composition ability and presentation skills.

Demonstrated documentation, meeting management, and leadership skills.

Must be computer literate with working knowledge of Microsoft Office

TRAVEL:

Ability to travel up to 20% of time. International travel may be required.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and walk through airports etc. The employee is required to go to all areas of the company and external study sites.

In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.

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