- Partner with R&D Marketed Product Project Manager to coordinate R&D function support for assigned products within the R&D MPT. Provide medical and clinical scientific leadership and expertise for assigned products to support other R&D function leads within the R&D MPT.
- Establish integrated partnership(s) with R&D functional leads on assigned R&D MPT (regulatory affairs, pharmacovigilance, global development operations).
- Collaborate with the commercial organization and Established Products Teams and Sub Teams. Also work directly with LOCs.
- Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including 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.
- Form integrated partnerships with and works with Global Product Team Leaders (GPL) and Established Product Team Lead (EPTL), and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across assigned products. Ensure the R&D MPT works to support GPT/EPTs.
- Form integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor medical and clinical deliverables for all products in assigned R&D MPT. Ensure highest quality of medical/clinical science input and clinical components of deliverables from the strategic partner vendor.
- Sponsor supervision and guidance for vendor medical monitors
- Partner with strategic partner vendor(s) and drive 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. Provide 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 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 individual subject safety. Assess overall safety information for studies and compound together with Pharmacovigilance. Make 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 to support regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
- Participate in non-project-specific initiatives and committees on behalf of project clinical perspective and general clinical science functional perspective.
- Present study conclusions to management and determine how individual study results affect the product strategy. Interpret data from an overall scientific and regulatory standpoint and 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. Support Local Operating Company (LOC) medical staff for all regulatory agency interactions as needed. Guide 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), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
- Provide scientific education and mentoring for internal and external audiences (academic partners, scientific community, regulatory agencies)
- Oversee compliance with internal SOPs and external legal requirements, including training of personnel, contractual arrangements with external service providers and partner companies.
- Participate, conduct and oversee clinical due diligence evaluations and development of clinical development plans for potential alliances and in-licensing opportunities.
- Assess both scientific and development feasibility, evaluating strategic fit with portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during due diligence visits and alliance negotiations, and participating on internal assessment teams together with commercial colleagues.
- MD or internationally recognized equivalent plus 8 years of clinical research experience in the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Experience in internal medicine, rare disease and/or immunology desired.
- Participation in NDA/MAA/Submission experience
- Track record and demonstrated ability to lead and manage both science and business aspects of drug development.
- Experience with and demonstrated ability to lead and manage trained medical, scientific and technical professionals
- Emerging research in Translational Medicine
- Nonclinical and clinical drug discovery and development
- TMS state-of-the-art technologies
- Regional/global Regulatory requirements
- GCP/ICH
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Senior Medical Director, Clinical Science, Marketed Products Development - Cambridge, United States - BioSpace
Description
Job DetailsBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Job Description for Senior Medical Director, Clinical Science, Marketed Products Development
As the Senior Medical Director Marketed Products (SMDMP) you will report to the Head of Global Clinical Science, Marketed Products Group and are accountable for Medical Sponsor and Clinical oversight for assigned marketed products globally, and contribute to new business evaluation of marketed products. Usually responsible for multiple products and at least one complex product.
The SMDMP is an integral member of a R&D Marketed Product Team (R&D MPT) that provides dedicated R&D support for the products under its purview. The MDMP interacts and partners with marketed products R&D function leads (regulatory affairs, pharmacovigilance, global development operations and project management) to set R&D strategy and prioritize R&D functional support for assigned MP portfolio. You will manage medical and clinical scientific leadership for the assigned R&D Marketed Product Team (R&D MPT) and product specific global program teams (GPT) or established product teams (EPT).
You will provides Medical Sponsor Oversight for all products managed by the R&D MPT as part of the dedicated, integrated R&D support to ensure the ability of Takeda to meet its corporate obligations as MAH for assigned products. The MDMP provides medical and clinical leadership to make sure that the R&D MPT anticipates potential compliance risks and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
You will be the medical and clinical scientific expert for the assigned products and to develop an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products to provide medical, clinical and scientific support, mentoring and leadership across these areas.
RESPONSIBILITIES AND ACCOUNTABILITIES:
You will be responsible for, and participate in the following activities:
Marketed Product R&D support & Leadership
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Cambridge - Kendall Square - 500
U.S. Base Salary Range:
$256, $402,600.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - MA - Cambridge - Kendall Square - 500
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
