Senior Scientists, Clinical
Senior Scientists, Clinical
- The senior clinical scientist will be a key player of a multi-disciplinary, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex clinical data findings. This individual has the responsibility for influencing the creation, maintenance, and execution of a clinical development plan that will have an impact on global strategies and may result in the regulatory approval of the compounds in multiple regions. The clinical scientist is a core member of the protocol and CSR development teams and is responsible for coordinating medical and scientific input into key documents.
- Represents Clinical Development on Development Teams and may serve as leader of this team. Ensures that the local Development Team activities are aligned with the global strategy.
- Contributes to high impact global decisions: monitoring and interpreting data from ongoing internal and external studies and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
- Contributes to major regulatory interactions and filing activities such as the preparation of agency meeting documents.
- Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them for those areas assigned.
- Participates in recommending scope, complexity and size, and influence the budget of all aspects of a program.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific, medical and corporate review committee approval including presentation and defense of the Synopses during review committee meetings
- Review and approval of documents related to study Protocols (e.g. Statistical Analysis Plans and Safety Management Plans) for assigned sections.
- Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings (e.g. Investigator Meetings).
- Responsible for review of study data, interpretation of results and communication of study conclusions within the company for assigned sections.
Trial Medical Monitoring
- Manages collection of necessary information to assess issues relating to protocol conduct and/or individual subject safety. Provides preliminary assessments to Medical Monitor for review and approval.
- Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.
- Contributes to interactions with regulatory authorities / agencies and key opinion leaders relevant to assigned projects
- Supports VP of Clinical Development in meetings with representatives of the regulatory organizations and the identification / contact / maintenance of strong Company relationships with key opinion leaders.
- Influences establishment of strategy for the compound, and the development of documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received by the Company.
- Responsible for successful incorporation of advice / recommendations received from organizations or specialists into the design of clinical studies / programs as appropriate.
- Collaborate with cross-functional team members to ensure accurate and timely completion/delivery of high-quality, medically and scientifically-justified documents.
- Interacts directly with other functional areas based on pertinent clinical and development expertise to provide knowledge / understanding of scientific/medical issues as an internal scientific content matter expert.
- May represent Clinical Development on internal projects. May lead internal teams as appropriate.
Candidate Requirements (External)
- Master s degree and 8 years/PharmD degree and 7 years/or PhD and 6 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned)
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
- Diplomacy and positive influencing abilities
- Oncology therapeutic area knowledge
- Emerging research in oncology therapeutic area
- Medical monitoring and trial execution
- Regional/global Regulatory requirements
Send resume and cover letter to email@example.com.