医学总监，临床试验医生 - 神经科 - FSP

Job Title: Medical Director, Clinical Trial Physician - Neurology (Remote) - FSP
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Join Thermo Fisher Scientific as a Medical Director/Clinical Trial Physician(FSP) based in the United States and be part of a world-class organization conducting groundbreaking research. 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).

*Must be legally authorized to work in the United States or Canada without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screening(where applicable).

*East coast time zone is preferred, or ability to work EST hours

Client Dedicated Role:

Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you're looking for a place where your work, in partnership with others, can have real impact—and where you're encouraged to challenge yourself and contribute to breakthrough solutions , the Medical Director/Clinical Trial Physician could be a great fit.

Discover Impactful Work:

Provides clear medical leadership in the Study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget.

A day in the Life:

• 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!

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Originally posted on Himalayas