Telecommute – North Wales, PA
REMOTE – Medical Director – OA
Location:North Wales PA USA
Kelly Outsourcing & Consulting Group is seeking to hire aREMOTEMedical Director for a long-term salaried opportunity with a comprehensive benefit package to support a growing biopharmaceutical company.
The Medical Director leads and drives strategy for the overall clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Sponsor pipeline compound(s). Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility for 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. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences trial decision-making by establishing strategic direction.
POSITION DUTIES & RESPONSIBILITIES:
Represents Clinical Development Team and will serve as medical science leader of this clinical trial. Supports the delivery of the study to ensure the progress of the Global Team to ensure that activities are aligned with the global drug development strategy. This individual will act as Trial Team Leader managing both global development for Phase II-III trials.
Responsible for providing support to 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.
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.
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.
Functional and Technical Competencies:
MD or internationally recognized equivalent plus 3-5 years minimums 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).
Previous experience successfully leading matrix tea…
North Wales, PA