Previous Job
Previous
Principle Clinical Research Scientist
Ref No.: 18-10809
Location: Milpitas, California
Position Type:Direct Placement
Start Date: 08/23/2018
OVERALL RESPONSIBILITIES:
¿ Reports to the Franchise Platform Leader or Sn Clin Res Mgr, MD CR&D;
¿ Responsible for Clinical R&D activities for assigned projects, including:
¿ Develop and deliver appropriate Global EGS / EDS to support NPD and 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 projects, 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;
¿ Lead in study design to develop appropriate clinical trials to meet the NPD / LCM needs;
¿ Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc
¿ Contribute in 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.
Functional and Technical Competencies:
• Thorough understanding of 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 provide strategic and scientific clinical research input across NPD and LCM
projects, including complex and / or 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, including complex projects;
• 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;
• 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 development and progression;
• Experience in effective management of project budget processes
Leadership

EDUCATION & EXPERIENCE REQUIREMENTS:
• Advanced degree in Ophthalmology, Optometry and PhD in related field is required.
• A minimum of 2 years related scientific / technical experience, including leadership /
management role within Clinical Research. If more Jr level candidate must have excellent
writing skills and HM would like to see published thesis etc as example of writing skills.