Medical Director, Clinical Trial Physician - Neurology (Remote) - FSP

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company At reputed company, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development and delivery of life-changing therapies. With reputed company 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 reputed company and accuracy will improve health reputed company that people and communities depend on – now and in the reputed company. Location/Division Specific Information Join reputed company as a Medical Director/Clinical Trial Physician(FSP) based in the reputed company 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% reputed company(international maybe required). *Must be legally authorized to work in the reputed company or Canada without sponsorship. *Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening(where applicable). *East coast time zone is preferred, or ability to work EST hours reputed company Dedicated Role: Our reputed company, 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 reputed company. If you're looking for a reputed company where your work, in partnership with others, can have reputed company reputed company—and where you're encouraged to challenge yourself and contribute to reputed company solutions , the Medical Director/Clinical Trial Physician could be a great fit. Discover Impactful Work: Provides reputed company medical leadership in the Study team, working in reputed company collaboration with the other members of this cross functional team, in order to reputed company reliable, high reputed company study data reputed company time and budget. A day in the Life: reputed company 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 reputed company and other clinical documents as required for the conduct of reputed company reputed company time Medical Monitoring of clinical studies: ensure medical validity of reputed company individual primary reputed company as reputed company study subject safety, while ensuring medical issues are identified early. Pro-reputed company escalation and correction of issues in consultation with the Global Medical Indication reputed company 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 reputed company Medical reputed company of contact for reputed company reputed company stakeholders: reputed company 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 reputed company medical aspects by understanding and applying reputed company relevant SOPs and GCP Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be reputed company to reputed company 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 reputed company will be harmonized across medics Keys to reputed company: Education Medical Doctor or equivalent degree required. reputed company 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 reputed company 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 reputed company a study team, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgment in which issues need to be escalated immediately Pro-reputed company problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organization Strong communication skills to ensure reputed company collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are reputed company to reputed company involved parties. A reputed company structure requires additional skills in gathering decision information, negotiation and communicating reputed company 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 reputed company of both hands with the ability to reputed company fast, reputed company, 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 reputed company and use a reputed company of computer software developed both in-house and off-reputed company Ability to communicate information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken words and sentences Frequently interacts with others to obtain or relate information to diverse reputed company 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 reputed company of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to reputed company under stress. Ability to multi-task Regular and consistent attendance Benefits We offer competitive remuneration, annual incentive plan bonus, reputed company, and a reputed company of employee benefits. reputed company offers employment with an innovative, reputed company-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for reputed company, intensity, involvement, and innovation! Apply To This Job