
VP, Medical Science & Strategy – Cardiovascular
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Job Level
About the role
- Ensuring the highest possible quality of input into significant requests for proposals (RFPs)
- 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
- Supporting outstanding input into other areas of the PPD clinical research business activities
- 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
- Providing therapeutic and developmental expertise to internal teams, including indication specific training for clinical teams
- Guidance during clinical trial 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
- Participate in multidisciplinary teams and working groups to contribute to innovative initiatives
Requirements
- 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.
- 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.
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical developmentregulatory issuesprotocol considerationsinvestigator brochure developmentclinical study report authoringNDA/MAA clinical packagesfeasibility studies designclinical trial executiontherapeutic expertiseclinical training
Soft Skills
decisivecustomer drivenflexible thinkingsmart-risk takingcontinuous improvementleadershipinfluencingmotivatingcommunicationconfidentiality
Certifications
MDboard certificationactive medical license