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.
*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening.
Discover Impactful Work:
The position requires proven abilities to drive both strategic and measurable business outcomes. The incumbent's oncology drug development track record and expertise is required to be extensive and ensure recognition as peer of their Pharmaceutical Industry equivalents. This position is playing a key part in the future success of PPD clinical research business of Thermo Fisher Scientific, as it seeks to continue its track record of successful growth and expand Industry leading position in the oncology field.
Medical Science & Strategy physicians are subject matter experts who support sales for proposals and bid defenses, engaging clients senior medical / scientific leadership in discussions and training internal staff on medical ad therapeutic requirements of the proposals.
A day in the Life:
The role comprises four major functions:
First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs), including:
Development strategy and regulatory issues
Drug class issues
Protocol and indication considerations, including safety
Team education on indication
Interactions with clients physicians and / or clients pneumology area leaders prior to and during bid defenses
Identifying business opportunities for PPD clinical research business
Second, the incumbent is responsible for supporting outstanding input into other areas of PPD clinical research business activities, including:
Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies whose portfolio contains drugs of business interest
Strategic alliance development & support
Client governance and advisory boards
Through PPD's consulting practice, the incumbent will provide Industry gold standard product development plans, and top-level design of clinical trial protocols that are required in the development plan.
Third, the incumbent will be responsible for providing therapeutic and developmental expertise to internal teams, including:
Indication specific trainings for clinical teams
Guidance during clinical trials executions
Investigator Brochure, clinical study report, NDA / MAA clinical packages development, and other regulatory briefing documents authoring and review
Contribute to design and reporting of feasibility studies
Liaise with investigators and KOLs
Mentor and supervise clinical scientists
Fourth, the incumbent will work with clinical scientists as external consultants to companies which require support in developing their pre-IND proposals and clinical development programs.
Finally, the incumbent will participate in multidisciplinary teams and working groups to contribute to innovative initiatives based in their specific knowledge, expertise and interest.
Education and Experience:
Certified oncologist with at least 10 years' experience in pharmaceutical industry leading oncology clinical development of at least one asset from discovery through registration, or having led asset development in each stage of development from discovery through NDA/BLA writing and registration.
Candidates must have early development experience and Pre-IND FDA consultation experience
Candidates must have demonstrated ability to function at enterprise level internally and externally. Able to engage/convene external panels of experts/advisory boards
Must have working knowledge of adaptive trials designs; familiarity with use of Bayesian statistics; practical experience in using AI tools.
Knowledge, Skills, Abilities :
Able to work in a matrix organization.
Able to demonstrate the following key high-level high performance behaviors: decisive, customer driven, flexible thinking, smart-risk taking and continuous improvement.
Leads, influences and motivates staff within and across departments.
Strong in presenting and communicating complex information clearly.
Able to deal with sensitive and confidential issues.
Possesses a "can do" attitude and is capable of implementing and following through on activities / projects.
Proficient in spoken and written English.
Flexibility to travel domestically and internationally
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!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
