Job Description
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.
The position requires proven abilities to drive both strategic and measurable business outcomes. The incumbent's cardiovascular diseases track record 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 the 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 cardiovascular diseases 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 and therapeutic requirements of the proposals.
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 client's physicians and / or client area indication leaders prior to and during bid defenses
- Identifying business opportunities for the PPD clinical research business
Secondly, the incumbent is responsible for supporting outstanding input into other areas of the 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.
Thirdly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal teams, including:
- Indication specific training 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
Finally, the incumbent will participate in multidisciplinary teams and working groups to contribute to innovative initiatives based on their specific knowledge, expertise and interest.
Minimum Qualifications:
- MD required; board certification preferred.
- At least 7 years of experience in the pharmaceutical industry leading cardiovascular clinical development programs, including advancement of at least one asset from discovery through registration.
- Active medical license preferred but not required.
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 and 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
What we offer:
- Full time position
- Competitive salary and benefits
- Work diversity, exposure to several assets in different stages of clinical development from several clients
- Mentorship and training
- Exciting work environment
About PPD clinical research business of Thermo Fisher Scientific Our mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today!
Job Tags
Full time, Work at office, Remote work, Flexible hours