Base pay range
$130.00/hr - $175.00/hr
Duration: 3+ months
REMOTE | EST preferred, or CST
Title: Medical Director, Clinical Science
Per HM: "Looking for an MD level external contractor to support 2 - 3 programs in Clinical Science in Marketed Products Development in Global Medical, with the possibility to extend based on program needs.
Preferred qualifications for this contractor position:
- MD (or equivalent) with experience in internal medicine and/or hematology, additionally rare disease area experience is preferred.
- Approximately 6 years of industry experience in clinical development. Less than 6 years might be considered based on specific areas of clinical development experience. Post marketing experience preferred.
- Experience in regulatory agency (FDA, EMA etc) interactions and contributing to clinical sections of submission documents
- Experience in contributing to safety reporting (e.g. PBRER)
- Experience in clinical study data review and preparation of clinical study reports.
- Strong collaborative skills and experience in working in a matrix team environment.
- This individual will be working closely with two Global Clinical Science Leads leading the programs and will report to me directly
Job Description:
- The Medical Director Marketed Products Development (MDMPD) Clinical Science is accountable for Medical Sponsor and Clinical oversight for assigned marketed products globally. Participates in new business evaluation. Usually responsible for multiple products.
- The MDMPD is an integral member of an Marketed Products Development Team (MPDT) in Global Medical that is responsible for providing dedicated support for the products under its purview. The MDMPD interacts and partners with marketed products MPD affiliated function leads (regulatory affairs, global safety/pharmacovigilance, global development operations and project management) to set Global Medical strategy and prioritize functional area support for assigned MP portfolio. This individual is responsible for medical and clinical scientific leadership for the assigned MPDT and product specific global program teams (GPT) or established product teams (EPT) as required,
- The MDMPD provides Medical Sponsor Oversight for all assigned products managed by the MPDT as part of the dedicated, integrated functional area support to ensure the ability of Client’s to meet its corporate obligations as MAH for assigned products. The MDMPD provides medical and clinical leadership to make sure that the MPDT anticipates potential compliance risks and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
- The MDMPD will be required to be the medical and clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products in order to provide medical, clinical and scientific support, guidance, mentoring and leadership across these areas.
