Kelly is seeking a Medical Monitor with oncology experience to support some Phase II and III NSCLC (Non Small Cell Lung Cancer) trials. This is a long term REMOTE opportunity to support a growing pharmaceutical company based in Cambridge, MA. The Medical Director leads and drives strategy for the overall regional (US/EU) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned pipeline compound(s).
- Clinical Development team participation and leadership
- Represents Clinical Science on global Development Teams and will serve as medical science leader of this team. Supports the delivery of the study to ensure the progress of the Global Development Team (US, EU, Japan) to ensure that the global Development Team activities are aligned with the global drug development strategy. May act as Global Development Team (US, EU, Japan) Leader managing both the GLOBAL Development Team and the Japan Development Team for an early or a smaller scope product.
- Responsible for providing support to the GCL (Global Clinical Lead) for global development plan. Recommends scope, complexity and size, and influence the budget of all aspects of a program. 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.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Oversees all Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to CRO and other cross-function team member involved in these activities, and be accountable for the successful design and interpretation of clinical studies independently. Presents 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 independently.
- Trial Medical Monitoring
- Responsible for overseeing medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety independently. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.
- Accountable on final decisions regarding study conduct related to scientific integrity with the support of GCL
- External Interactions
- Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. 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 reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders independently. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate
- Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations and represents clinical science on internal assessment teams in conjunction with global counterparts. For ongoing alliance projects, will interface with partner to achieve strategic goals while striving to maintain good working relationship between Customer and partner.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts with research division based on pertinent clinical and development expertise and with NA/EU to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds. Represents clinical science and leads internal task forces and internal teams as well as global cross-functional teams as appropriate.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- MD or internationally recognized equivalent 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).
- Medical practice or late phase clinical research in oncology and regulatory interaction is required
- Clinical and translational knowledge relevant to NSCLC or other oncology indications
- Knowledge of medical monitoring and adverse event management
- 2-5 years industry experience with CSR writing and data review experience preferred.
This position comes with enhanced benefits which include:
- 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)
- Paid sick days and vacation days
*benefits to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
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