Director Strategic Clinical Development Consulting

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging 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 025 range annually. This position is within our Strategic Scientific Solutions (S) team. S 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 experiencebased tailored solutions for clients. In addition this position provides oversight and engagement including responsibility over multidisciplinary 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 multidisciplinary team of subject matter experts across core fields engaged in consulting with clients for early through latestage development of medical products
• Provide scientific expertise and preclinical and/or clinical and clinical trials knowledge to deliverables
• Project 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 Fisher
• Serve as a client relationship lead building and maintaining strong client relationships based on expertise in one or more scientific fields
• Lead planning and performing activities in key relationships; see opportunities/gaps to improve asset goal delivery
• Manage support infrastructure and provide direct support for winning full product development programs and consulting services contracts
• Work 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 budget
• Collaborates 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 BD
• Actively engages in BD activities focusing on the expansion of the departments global footprint
• Delivers solid business plans that incorporate clear goals objectives and tangible activities that lead to success
• Coordinates 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 indicators

Keys to Success:

Education

• An advanced degree (MD PhD PharmD or equivalent) is required

Experience

• 12 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 preferred
• 7 years of clinical development experience including experience with early and/or late phase clinical development strategy and understanding of regulatory environment
• Demonstrated experience in the design and of clinical trials and supporting studies for medical product development
• Track record of external visibility and peerreviewed publication list strongly preferred
• Candidates 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 Abilities

• Experience developing strategies to support the design and implementation of an efficient and effective clinical program leading to market authorization
• Experience leading facilitating coordinating and managing all activities related to planning and implementing clinical development programs throughout the entire product lifecycle
• Experience building and driving optimal of integrated product development plans and proactively developing mitigation and contingency planning
• Experience 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 portfolios
• Ability to cultivate crossfunctional collaborations within a matrixed team environment
• Strong decisionmaking and analytical skills are required
• Excellent communication and influencing skills
• Solid knowledge of worldwide regulatory requirements processes and regulatory authority interactions
• Excellent organizational skills professional conduct dedicated and detail orientated
• Flexibility to travel domestically and internationally
• Proven track record to work independently and effectively on multiple tasks in a fastpaced entrepreneurial environment to be selfmotivated and to communicate effectively with senior management

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 68 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 1520 lbs.
• Ability to access and use a variety of computer software developed both inhouse and offtheshelf
• 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 multitask
• 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 forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!