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:

Fully Remote, based in the United States. Work related travel expected in a 0-25% range annually. This position is within our Strategic Scientific Solutions (S³) team. S³ operates through specialized pillars, each covering distinct therapeutic and functional areas. These pillars will be composed of medical, clinical and operations expert teams, ensuring that every aspect of our work is informed by deep, specialized technical and scientific knowledge.

Discover Impactful Work:

Applies firsthand strategic and scientific knowledge of clinical development of medical products to address a range of client needs for a range of therapeutic modalities (e.g., small molecules, vaccines, biologics, biosimilars, and devices). This includes creating experience-based, tailored solutions for clients. In addition, this position provides oversight and engagement, including responsibility over multi-disciplinary teams and review of all client deliverables.

The Strategic Clinical Development Consultant leads internal and external relationships and assembling and managing joint development teams aimed at supporting clinical development programs for medical products. This position acts as senior oversight for programs and ensures effective communication with client teams and Thermo Fisher Scientific partners. The Consultant works in collaboration with and on behalf of clients to design and implement product development strategy on both local and global levels.

A day in the Life:Responsible for providing clinical development expertise and leading a multi-disciplinary team of subject matter experts across core fields engaged in consulting with clients for early through late-stage development of medical productsProvide scientific expertise and pre-clinical, and/or clinical, and clinical trial's knowledge to deliverablesProject lead for a team of experts in regulatory strategy, product development, biostatistics, clinical science, and pharmacokinetics consulting functions within the department and more broadly within PPD and Thermo FisherServe as a client relationship lead, building and maintaining strong client relationships based on expertise in one or more scientific fieldsLead planning and performing activities in key relationships; see opportunities/gaps to improve asset goal deliveryManage support infrastructure and provide direct support for winning full product development programs and consulting services contractsWork with project manager to oversee project budgeting/forecasting. This may include creatively adjustment to resourcing and allocations to changes in scope of personnel requirements to stay within project budgetCollaborates with business development (BD) and executive management in Thermo Fisher, secures new business by making presentations to clients, developing and reviewing bid proposal texts and budgets, and conducting contract negotiation through to closure with the client and BDActively engages in BD activities focusing on the expansion of the department's global footprintDelivers solid business plans that incorporate clear goals, objectives and tangible activities that lead to successCoordinates the development and implementation of systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics, and other key performance indicatorsKeys to Success:EducationAn advanced degree (MD, PhD, PharmD or equivalent) is requiredExperience12+ years in the pharmaceutical/biotech industry, with significant experience in different therapeutic areas, or very deep experience in at least one therapeutic area. Immunology backgrounds are highly preferred7+ years of clinical development experience, including experience with early and/or late phase clinical development strategy and understanding of regulatory environmentDemonstrated experience in the design and execution of clinical trials and supporting studies for medical product developmentTrack record of external visibility and peer-reviewed publication list strongly preferredCandidates with a Clinical Science Liaison background that includes clinical development are encouraged to apply

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, AbilitiesExperience developing strategies to support the design and implementation of an efficient and effective clinical program leading to market authorizationExperience leading, facilitating, coordinating, and managing all activities related to planning and implementing clinical development programs throughout the entire product lifecycleExperience building and driving optimal execution of integrated product development plans and proactively developing mitigation and contingency planningExperience leading development of strategic documents (e.g., integrated development plans, clinical development plans, life cycle plans, target product profiles)Experience managing alliances, sponsor partnerships, and complex projects and portfoliosAbility to cultivate cross-functional collaborations within a matrixed team environmentStrong decision-making and analytical skills are requiredExcellent communication and influencing skillsSolid knowledge of worldwide regulatory requirements, processes, and regulatory authority interactionsExcellent organizational skills, professional conduct, dedicated, and detail orientatedFlexibility to travel domestically and internationallyProven track record to work independently and effectively on multiple tasks in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with senior managementPhysical Requirements / Work Environment Work 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!