DIRECTOR, CLINICAL SCIENCE
ABOUT THE POSITION:
The Director, Global Clinical Science (GCS) supports the strategy for Global Clinical Development taking into consideration the medical, scientific, regulatory and commercial issues for assigned products. He/she leads and manages a clinical study project or projects, which span through a cross-functional, multi-regional, matrix team involving highly complex decisions. They will be involved with development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the compound in multiple regions. The Associate Director creates all types of clinical regulatory documents (e.g., protocol, CSR, IB, and clinical sections of other regulatory documents) according to company guidelines and international governmental regulations and will present clinical data objectively in a clear, concise format.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
Clinical Development team participation and leadership
- Supports the Global Clinical Science Senior Director in representing Global Clinical Science on US/EU/Japan development teams. Supports the Global Development Team to ensure that the Team activities are aligned with the global strategy.
- Ongoing work output will involve 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. Recommends high impact global decisions.
- Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications 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. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
This position is for an independent, proactive, experienced medical writer with demonstrated leadership preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD who can guide others in these processes. They will guide medical writing activities (including document preparation and/or production) for assigned regulatory submissions or projects. They will also be responsible for the preparation of presentation material for Scientific Advisory Boards and Clinical sections of the Investigator Meetings. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. Effectively delegates and intervenes as required to maintain optimal productivity.
The Director identifies, manages and cultivates key opinion leaders (KOLs), Investigators and Scientific Advisors. In addition, they will direct interactions with KOLs relevant to assigned compounds and therapeutic area on behalf of GCS. Provides leadership in meetings and negotiations with key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing documents), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
Serves as the INCAPTUS expert and utilizes this program to collaborate with external experts and communicate with KOLs and Investigators.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- The Director will support the Senior Director GCS in overseeing assigned Global Clinical Science activities relating to the preparation / approval of Protocol Synopses, Protocols and the conduct of clinical studies. They will serve as the Clinical science expert supporting other Cross-functional departments and will be accountable for the successful design and interpretation of assigned clinical studies. They will assist in presenting study conclusions to management and determines how individual study results impact the overall compound strategy.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
The Director supports the Senior Director GCS for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. They will assess overall safety information for studies and compound in conjunction with Pharmacovigilance. They will report their assessments to the Senior Director GCS who makes final decisions regarding study conduct related to scientific integrity.
Core compentencies, education, and experience.
- MD or internationally recognized equivalent or PhD plus 3-5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Strong medical writing skills required
- Previous experience successfully leading matrix teams preferred.
- Ophthalmology experience preferred.
- Creativity and innovativeness are clearly expected. Should have supervised a number of clinical studies (or fewer if some are large multicenter studies), which have yielded clear-cut results and demonstrated the ability to establish satisfactory interpersonal relationships with others in the working environment, and to manage other physicians.
- Proven track record of success, especially in the area of thought leader engagement and experience working with academic centers of excellence Exemplary interpersonal communication skills, both oral and written, and strong presentation skills.
- Demonstrated ability to comprehend complex scientific data and concepts and communicate effectively with a variety of audiences.
- Authored papers in leading journals or evidence of having supported such publications.
- Presented scientific data in conferences and supported the preparation of such presentations by KOLs.
- Awareness and understanding of regulatory guidelines (FDA, PDMA, PhRMA, etc.).
- Strong analytical, conceptual, administrative, and computer skills.
- Ability to approach work with a strong domestic and global perspective.
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