Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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 Senior Medical Director based in the United States and be part of a world-class organization conducting groundbreaking research. This position is fully remote, benefit eligible with travel in a 10-20% range(international maybe required).

Discover Impactful Work:

Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line management accountability. Works collaboratively and serves as the primary point of contact between the PV physician group and other PV leaders (MPC group leadership, etc). Provides leadership and strategy to multidisciplinary teams within PV and across the company, not limited to PV operations, training development, business objectives, quality initiatives and management, process improvement, compliance, and innovation. Applies therapeutic area expertise and indication-specific knowledge to provide medical consultation and strategic direction, and risk mitigation strategies to internal teams and clients. Supports business development activities. Manages (direct-line or matrix), mentors, and oversees PV physicians globally to support training and end to end medical monitor and/or safety physician activities and supporting services across the pharmaceutical product life cycle. Encourages a culture of accountability and continuous process improvement. Develops and manages resource allocation plans and budgets.

Serves as the PV physician team liaison with other PPD departments and clients. May provide oversight of medical review and analysis of data for clinical trial serious adverse events, aggregate review (e.g., trending and listings), marketed products ICSR and periodic safety reports (e.g., PBRER, PSUR, DSUR), and other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP, signal detection reports and CSR).

A day in the Life:Provides global and regional medical leadership, mentoring and oversight to direct reports (if applicable) and global PV physician team. Serves as a consultant and spokesperson of PV physician team or external spokesperson for the PV organization on significant matters.Utilizes subject matter clinical and pharmacovigilance expertise, combined with knowledge of the product(s) or therapeutic area to interpretation of safety and efficacy data, therapeutic and protocol training, identify and evaluate safety signals and to drive decision-making on risk/benefit evaluation and argumentation, pharmaco-epidemiological or clinical trial data interpretation, and risk assessment, if applicable.Creates formal networks with key decision makers. Collaborates with cross-functional group leaders to develop, promote, and contribute to strategic process improvement initiatives and planning of training and development programs.Serves as the primary point of contact for activities related to quality and reporting compliance of safety reports, and as subject matter expert for these topics during audits and inspections.Assists in the development and implementation of policies to enhance the effectiveness of the PV department. Identifies unusual or significant issues related to safety and/or medical monitoring processes and proposes prevention and/or correction strategies.Provides insight and participates in new business/business development strategy calls, proposal development, bid reviews and parameters for business deliverables.Provides global leadership in medical safety and risk mitigation activities for projects and clients (e.g., primary point of contact), foster client relationships and supervises strategic sell initiatives of the PV department.Provides expertise and oversight of study start-up activities for medical deliverables.Communicates with sponsors to obtain direction and feedback on implementing program scope of work and performance.Actively participates in recruiting efforts and selection process.If applicable, provides new hire onboarding, salary administration, performance management, promotion and discharge activities, and conflict resolution.Maintains understanding of contracts and budgets, methods for recording time spent on project and administrative tasks, expense submissions and travel.If applicable, attends and contributes at MD management and allocation calls.Cultivates a supportive, motivating, and collaborative work environment. Builds an effective and productive team focused on overall corporate deliverables. Helps ensure projects and initiatives align with company culture.Keys to Success:EducationMD or equivalent required. History of an active medical license highly preferred.Total previous professional experience that provides the knowledge, skills and abilities to perform to job (comparable to 12+ years).Candidates should have clinical experience in treating patients in specialty or sub-specialty with direct responsibility for diagnostic and treatment decisions of at least 2 years and Clinical trial experience in a CRO, pharmaceutical company or as a principal investigator in the industry of at least 5 years.Candidates with backgrounds as a Cardiologist with clinical development/medical monitoring experience are preferred.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, AbilitiesTherapeutic and indication-specific development expertise across one or more therapeutic areas and/or one or more drug classes, including deep knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscapeDeep knowledge of important regulatory considerations governing adverse event reporting and experience with FDA, EMA and other national and international regulatory authoritiesExperience as a medical strategy leader for multidisciplinary teams with mastery of medical management tasks (review AEs, protocol inquiries, listings, diagnostic reports, data trending, etc.) and/or safety tasks (signal detection activities, aggregate report generation, label update contribution, dossier maintenance support, and risk management activities)Thorough understanding of guidelines for marketing authorization submissions and international guidelines for conduct of clinical studiesStrong decision-making, negotiation, and analytical skillsExcellent communication and influencing skillsExcellent organizational skills and detail-orientated leadership approachAbility to tactfully supervise and objectively evaluate medical staffAbility to mentor effectively in both one-on-one and in group settingsFlexibility to travel domestically and internationallyAbility to work independently on multiple tasks in a fast-paced environmentProficient in basic computer applicationsOverall knowledge of the drug development processAbility to effectively manage direct reports (if applicable)Physical Requirements / Work EnvironmentWork is performed in an office environment with exposure to electrical office equipmentOccasional drives to site locations with occasional travel both domestic and internationalFrequently stationary for 6-8 hours per dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wristsFrequent mobility requiredOccasional crouching, stooping, bending and twisting of upper body and neckLight 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-shelfAbility 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 sentencesFrequently interacts with others to obtain or relate information to diverse groupsWorks independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentrationPerforms 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-taskRegular and consistent attendanceBenefits

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!