Thermo Fisher Scientific
VP, Medical Science and Strategy - Hematology/Oncology
Thermo Fisher Scientific, Raleigh, North Carolina, United States
VP, Medical Science and Strategy - Hematology/Oncology
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Overview 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 resources to achieve individual career goals while advancing science through research, development and delivery of life-changing therapies. Our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes for people and communities now and in the future.
Responsibilities
First function: ensure the highest quality input into significant 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 client leaders prior to and during bid defenses
Identifying business opportunities for PPD clinical research business
Second function: support input into other PPD clinical research activities, including:
Pro-active client engagement with therapeutic area leaders and senior directors
Strategic alliance development & support
Client governance and advisory boards
Provide industry-standard product development plans and top-level design of clinical trial protocols
Third function: provide therapeutic and development expertise to internal teams, including:
Indication-specific trainings for clinical teams
Guidance during clinical trial executions
Authoring/review of Investigator Brochure, clinical study reports, NDA/MAA documents, and regulatory briefing materials
Contribute to design and reporting of feasibility studies
Liaise with investigators and KOLs
Mentor and supervise clinical scientists
Fourth function: collaborate with clinical scientists as external consultants to support pre-IND proposals and clinical development programs.
Participate in multidisciplinary teams to contribute to innovative initiatives based on your knowledge and interests.
Education and Experience
Certified oncologist with at least 10 years’ experience in the pharmaceutical industry, leading oncology clinical development of at least one asset from discovery through registration, or leading asset development through all stages up to NDA/BLA writing and registration.
Early development experience and Pre-IND FDA consultation experience
Ability to function at enterprise level internally and externally, including convening external panels of experts/advisory boards
Working knowledge of adaptive trial designs; familiarity with Bayesian statistics; practical experience using AI tools
Knowledge, Skills, Abilities
Ability to work in a matrix organization
Strong high-level behaviors: decisive, customer-driven, flexible thinking, smart-risk taking, continuous improvement
Leads, influences and motivates staff across departments
Strong presentation and communication of complex information
Ability to handle sensitive and confidential issues
Can-do attitude with the ability to implement and follow through on activities/projects
Proficient in spoken and written English
Flexibility to travel domestically and internationally
Physical Requirements / Work Environment
Office environment with exposure to electrical equipment
Occasional travel domestically and internationally
Frequently stationary for extended periods
Manual dexterity for computer use and fine motor tasks
Ability to communicate effectively and work with diverse groups
Independent work with goal-oriented planning and 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 provides an innovative, forward-thinking organization with outstanding career and development prospects and a culture centered on integrity, intensity, involvement, and innovation.
Job Details
Employment type: Full-time
Seniority level: Not Applicable
Job function: Research and Science
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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Get AI-powered advice on this job and more exclusive features.
Overview 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 resources to achieve individual career goals while advancing science through research, development and delivery of life-changing therapies. Our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes for people and communities now and in the future.
Responsibilities
First function: ensure the highest quality input into significant 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 client leaders prior to and during bid defenses
Identifying business opportunities for PPD clinical research business
Second function: support input into other PPD clinical research activities, including:
Pro-active client engagement with therapeutic area leaders and senior directors
Strategic alliance development & support
Client governance and advisory boards
Provide industry-standard product development plans and top-level design of clinical trial protocols
Third function: provide therapeutic and development expertise to internal teams, including:
Indication-specific trainings for clinical teams
Guidance during clinical trial executions
Authoring/review of Investigator Brochure, clinical study reports, NDA/MAA documents, and regulatory briefing materials
Contribute to design and reporting of feasibility studies
Liaise with investigators and KOLs
Mentor and supervise clinical scientists
Fourth function: collaborate with clinical scientists as external consultants to support pre-IND proposals and clinical development programs.
Participate in multidisciplinary teams to contribute to innovative initiatives based on your knowledge and interests.
Education and Experience
Certified oncologist with at least 10 years’ experience in the pharmaceutical industry, leading oncology clinical development of at least one asset from discovery through registration, or leading asset development through all stages up to NDA/BLA writing and registration.
Early development experience and Pre-IND FDA consultation experience
Ability to function at enterprise level internally and externally, including convening external panels of experts/advisory boards
Working knowledge of adaptive trial designs; familiarity with Bayesian statistics; practical experience using AI tools
Knowledge, Skills, Abilities
Ability to work in a matrix organization
Strong high-level behaviors: decisive, customer-driven, flexible thinking, smart-risk taking, continuous improvement
Leads, influences and motivates staff across departments
Strong presentation and communication of complex information
Ability to handle sensitive and confidential issues
Can-do attitude with the ability to implement and follow through on activities/projects
Proficient in spoken and written English
Flexibility to travel domestically and internationally
Physical Requirements / Work Environment
Office environment with exposure to electrical equipment
Occasional travel domestically and internationally
Frequently stationary for extended periods
Manual dexterity for computer use and fine motor tasks
Ability to communicate effectively and work with diverse groups
Independent work with goal-oriented planning and 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 provides an innovative, forward-thinking organization with outstanding career and development prospects and a culture centered on integrity, intensity, involvement, and innovation.
Job Details
Employment type: Full-time
Seniority level: Not Applicable
Job function: Research and Science
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Thermo Fisher Scientific.
#J-18808-Ljbffr