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.
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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 registration.
- Candidates with early development experience and Pre-IND FDA consultation experience are highly preferred.
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
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!