Work Schedule

Environmental Conditions

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

Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives. This role is open to U.S and EMEA.

Discover Impactful Work:

As VP, Early Development CRO Services, you will provide strategic leadership and oversight of Clinical Operations for the EDS CRO Services segment. Responsible for the overall management and performance of all areas relating to the end-to-end EDS Clinical Operations including Project Management, Clinical teams, Data Management, Biostatistics, Programming, and Medical Writing. Responsible for overseeing, coordinating, capturing and reporting the data for EDS trials for PPD's major pharmaceutical and biotech clients.

A day in the Life:

• Oversees the daily clinical operations of EDS CRO segment and works closely with all business segment leaders and managers to ensure client goals and timelines are achieved or exceeded.
• Provides leadership through effective staffing, performance management and development. Develops the infrastructure, systems, processes and policies to effectively deliver innovative and customized solutions to meet clients’ needs.
• Ensures the scheduling of studies annually to achieve revenue goals.
• Interacts with Business Development for scheduling purposes and to drive business. Travels to client companies for business development opportunities. Participates in industry conferences annually for the purpose of solidifying client relationships and bringing in new business.
• Maintains client relationship to ensure client satisfaction, addresses quality and regulatory issue
• Leads the development and rollout of automation modules designed to streamline processes and enhance quality within the EDS Clinical setting.
• Ensures revenue is tracked and reported accurately to Finance.
• Works with Sr. Management team on an ongoing basis to develop and implement yearly business plan goals and objectives.

Keys to Success:

Education

• Bachelor’s degree in scientific field or related discipline

Experience

• Previous clinical research experience (comparable to 15+ years), including 5+ years in Phase I
• A visionary leader with at least 10 years of clinical operations management experience and a strong background in project coordination and regulatory experience.
• Candidates with direct CRO knowledge and experience are highly 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, Abilities

• Thorough knowledge of all aspects of the drug development process, specifically Phase I
• Advanced leadership skills and executive presence
• Proven negotiation skills and ability to effectively influence executives and other stakeholders
• Exceptional business acumen with comprehensive understanding of the organization and functional areas
• Ability to work in a high pressure/time sensitive environment including the ability to handle multiple issues on multiple projects simultaneously.
• Advanced knowledge of strategic planning, budgeting, forecasting and fiscal management
• Excellent verbal and written communication skills
• Proficiency in Microsoft Office Tools
• Ability to motivate large numbers of employees through stressful situation

Physical Requirements / Work Environment

• Work is performed in an office and/or clinic environment with exposure to electrical office equipment
• Occasional exposure to various investigational products including radio labeled products
• Occasional exposure to infectious disease and biohazardous material
• Frequently visits site locations, frequently travels within the United States and EMEA, occasional international travel with limited advance notice.
• Working hours are long and varied including weekends and holidays
• Nature of the business requires constant accessibility and feedback to staff and clients which often involves interaction with staff/clients verbally or by email after hours and on weekends
• 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
• Moderate 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 complex 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, relates sensitive information to diverse groups both internally & externally
• Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration
• Performs a wide range of complex 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!