Senior Principal Clinical Research Scientist

Senior Principal Clinical Research Scientist - Diegem, Belgium

OVERALL RESPONSIBILITIES:

Responsible for Clinical R&D activities for multiple and/or complex projects, including:

Lead the development and deliver appropriate Global Evidence Generation and Dissemination Strategies (EGS/EDS) to support New Product Development and life cycle Management for transformational/complex programs, with collaborative relationships with all relevant CR&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R

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

Lead in study design to develop appropriate clinical trials to meet the NPD/LCM needs;

Lead in the appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs, etc

Lead 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;

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

Non Technical Skills and Additional Details

Functional and Technical Competencies:

Deep 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;

Ability to lead cross-functional teams to provide strategic and scientific clinical research input across NPD and LCM projects, including complex/transformational 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

Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders; 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, this individual will support shaping a high-performing team with a global culture;

Leadership Competencies: Strong leadership: 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 - continue to develop expertise in the development of strategic and scientific clinical research strategies for complex programs

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.

EDUCATION & EXPERIENCE REQUIREMENTS: A Bachelor's or equivalent degree in Biological Science or related discipline. A minimum of 8 years related scientific/technical experience, including leadership/management role within Clinical Research.