*Improved Signing Bonus Maybe Available For Qualified Candidates*
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 - To enable 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.
Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on - now and in the future.
Summarized Purpose for the Medical Director-Investigator:
Serves as the investigator on all assigned clinical trials providing medical oversight for a particular protocol and client. Ensures that the protocol is being conducted under all applicable laws, regulations and per ICH-GCP guidelines in the organization's Clinical Research Unit (CRU). Consults with clients and provides scientific and medical insight for protocols. Researches compounds being considered by the CRU for subject safety. Evaluates and signs off on medical data collected, completed case report forms (CRFs) and final clinical study reports (CSRs). Build and maintains strategic relationships with clients and partners with operational and business development staff. Liaises with senior level management to provide medical guidance and oversight at the CRU.
Essential Functions:
Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
Reviews and establishes protocols for scientific, logistical and safety feasibility, as requested.
Ensures adherence to client directives and study protocols for assigned projects.
Performs role as described in FDA Form 1572, including, but not limited to informed consent and screening examinations of subjects, clinical management of safety issues for the individual subjects as well as the study cohort.
Presents all first-in-human and other high risk trials to the Human Safety Committee (HSC) to ensure those trials are thoroughly reviewed and approved by the voting members. Provides expertise and leadership in the development of risk management plan(s) (RMP) with the Project Manager to mitigate any risk to subject safety for all studies.
Provides or oversees training on assigned studies, as requested.
Provides consultation on medical concerns with medical monitors (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, as appropriate, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
Provides medical consultation to team members and answers study related medical questions. Communicates with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Deviates from current approved study protocol only if it is in the medical emergent safety needs of a subject.
Leads the monitoring, evaluation and action plan as needed on safety variables (adverse events, laboratory/ECG abnormalities, changes in subject medical status and un-blinding requests) during a clinical trial.
Assesses reported adverse events and determines causality and study drug relationship. Assesses and determines the clinical significance of out of range laboratory values and other observed abnormalities noted within safety assessments.
Develops and implements departmental process improvement initiatives.
Trains and supervises more junior team members.
Attends senior level leadership meetings and partners to drive strategic department initiatives.
Education and Experience:
MD or DO required. Board Certification preferred. Active medical licensure(with prescription authority) within Florida required. Candidates should have a combination of clinical experience and industry experience as follows:
Exceptional general medical practitioner diagnosis and treatment proficiency
At least one-year experience working in clinical research, or comparable research/clinical expertise to demonstrate the ability to work in clinical trials.
Candidates with Neurologist backgrounds are highly preferred
Knowledge, Skills and Abilities:
In-depth knowledge of important regulatory considerations and experience with national and/or international regulatory authorities
Proven ability to assess the safety and tolerability of different classes of drugs
Thorough knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve
Exceptional analytical ability
Demonstrated bility to exercise discretion and sound judgement
Superb decision-making, negotiation and influencing skills
Excellent communication skills and English fluency
Excellent organizational skills and detail-orientated leadership approach
Proficiency in basic computer applications
Ability to work in a team environment
Working Conditions and 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.
Physical Requirements:
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.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
