Job Description

Overview

Join Thermo Fisher Scientific as a Medical Director/Clinical Trial Physician (FSP) based in the United States. Ideal candidate location is Eastern or Central Time Zone. This position is fully remote, benefit eligible with travel in a 10-20% range (international maybe required).

Responsibilities

• Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information; contribute to site selection; contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
• Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early; pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead
• Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead
• Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications
• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
• Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
• In case more than 1 physician is working on the protocol, a primus inter pares will be appointed, and they will ensure that answers to questions from sites/IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics

Keys to Success

Education

• Medical Doctor or equivalent degree required. Board certification(s) are preferred
• Specialty education (e.g. residency/fellowship) required in neurology. This should be accompanied by patient treatment and/or research experience
• 1-3 years of industry experience required. Experience should be in clinical development in a Pharmaceutical, Biotech or CRO organization
• Neurologists with expertise in Pediatric Neurology or Neuromuscular diseases are highly preferred

Knowledge, Skills, Abilities

• Excellent English, both written and spoken is a must, as well as ability to travel
• Shown understanding and experience with NDA submission process
• Shown understanding of regulatory guidelines for adverse event reporting
• Proven interpersonal skills enabling to lead a study team, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgment in which issues need to be escalated immediately
• Pro-active problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organization
• Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and actions

Physical Requirements / Work Environment

• Work is performed in an office environment with exposure to electrical office equipment
• Occasional drives to site locations with occasional travel both domestic and international
• Frequently stationary for 6-8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Frequent mobility required
• Occasional crouching, stooping, bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task
• Regular and consistent attendance

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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