Details for the position are as follows:
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.
- 6-month contract to start with the possibility of extension or conversion depending on performance and budget.
- Rate: $160-181 an hour
- Location: Remote (must be okay working either EST or CST hours mainly)
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.
- Partner with Marketed Product Project Manager to coordinate functional support for assigned products within the MPDT. Provide medical and clinical scientific leadership and expertise for assigned products to support other function leads within the MPDT.
- Establish integrated partnership(s) with MPD affiliated functional leads in R & D (regulatory affairs, global safety/pharmacovigilance, global development operations).
- Collaborates with the commercial organization and Established Products Teams and Sub Teams
- Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
- Forms integrated partnerships with and works with Global Product Team Leaders (GPL) and Established Product Team Lead (EPTL) as necessary, and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across assigned products. Ensure the MPDT in Global Medical works effectively to support GPT/EPTs.
- Medical Monitoring and supervisions and guidance for vendor medical monitors.
- Forms integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor medical and clinical deliverables for all products in assigned MPDT. Ensure highest quality of medical/clinical science input and clinical components of deliverables from the strategic partner vendor.
- Partners with strategic partner vendor(s) and drives medical and clinical scientific activities relating to the preparation/approval of protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed. Provides Takeda oversight of strategic partner MDs/clinical staff involved in these activities. Accountable for the successful design, execution and interpretation of clinical studies.
- Oversee the strategic partner vendor(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, protecting the safety of patients within the study. Responsible for internal oversight of strategic partner vendor medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with global safety/Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity.
- Establish integrated partnership with strategic partner clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
- Participates in cross functional non-project-specific initiatives and committees on behalf of project clinical perspective.
- Presents study conclusions to management and determine how individual study results impact the product strategy. Interprets data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients.
- Participate in and support all required regulatory submissions/interactions for assigned products. Represent Takeda as Responsible Medical Doctor and Medical/Clinical expert to regulatory agencies globally for assigned products as needed. Support Local Operating Company (LOC) medical staff for all regulatory agency interactions as needed. Drive medical and clinical scientific input and development of required documents for regulatory applications/submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
- MD or internationally recognized equivalent
- 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 internal medicine and/or hematology, additionally rare disease area experience is 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.