Director/VP Clinical - Charles City, United States - VIDA Connected Specialists

Description

VIDA Connected Specialists provided pay range

This range is provided by VIDA Connected Specialists. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range

$180,000.00/yr - $230,000.00/yr
Direct message the job poster from VIDA Connected Specialists
Director / VP Clinical - Neurostimulation

Remote based :
East Coast, but will consider Mid-West or West Coast if exceptional
VIDA continue to partner with a pioneering start-up in the field neurostimulation.
To align with our clients clinical strategy we are now seeking a highly experienced clinical leader with experience in the field of

stroke, neurology

or

neurostimulation

clinical trials.
Start up experience being a big plus

Function:
Full strategic and leadership responsibility for the Clinical division. Management of the overall clinical development strategic programs, clinical trials and related activities.
Full alignment with the Executive and Commercial Team on business objectives.

Responsibilities:
Responsible for execution of all clinical trials and project management of all clinical activities.
Assurance of clinical trial conduct in accordance to all regulations (e.g. regulatory guidelines,
national/international standards).
Lead the global clinical organization, including mentoring and developing clinical team members to foster individual growth and promote internal talent
Provide management support and leadership in the design, development, implementation and successful execution of clinical studies and processes
Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk

Contribute to the development of integrated Clinical Regulatory Strategy through cross functional collaboration with R&D, Regulatory Affairs, Quality and Executive teams.

Present to the Executive Team and Board of Directors, when needed, all updates and short- and long-range planning for clinical functions.

Ensure that goals and objectives of the clinical program are met by providing tactical input into the planning and execution of clinical trials.

Prepare clinical study plans and ensure studies are completed on time and within approved budget, and conducted and monitored in accordance with GCP/ICH requirements.

Support the Head of Clinical Operations with clinical trials, including selection, contracting, and management of sites. Facilitate communication with contract service providers on study related matters.
Forecast investigational product needs
Manage Global Clinical budget, forecast, and resource allocation

Oversee the preparation of clinical study documents, including Protocols and Amendments, Investigator's Brochures, Informed Consent Forms and Clinical Study Reports.

Extensive experience at senior level in Strategic Clinical development
Clinical leadership experience within medical devices successfully running both European and US studies
Working knowledge of ICH/GCP guidelines, FDA and EMA regulations
Clinical trial design and management
Risk management in clinical trials
Working within a small and / or start-up organization
Working with or in hospital clinical trial structures
Reach out to James Gillman at VIDA - or apply via the posting
Seniority level

Seniority level

Director
Employment type

Employment type

Full-time
Job function

Job function

Project Management, Health Care Provider, and Research
Industries

Medical Equipment Manufacturing
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