Director, Strategic Clinical Development Consulting Position Available In [Unknown county], North Carolina

Director, Strategic Clinical Development Consulting
This job is available in 4 locations See all Job Id

R-01311174

Job Type Full time Category Clinical Research Remote Fully Remote
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 products
Provide scientific expertise and pre-clinical, and/or clinical, and clinical trial’s 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 department’s 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 execution of clinical trials and supporting studies for medical product development
Track record of external visibility and peer-reviewed 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 execution 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 cross-functional collaborations within a matrixed team environment
Strong decision-making 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 fast-paced entrepreneurial environment, to be self-motivated, 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 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
Benefits
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!