Takeda
Location: Cambridge,MA, USA
Date: 2024-11-15T03:09:15Z
Job Description:
- The Director Clinical Science - M.D. is responsible for providing strategic direction and oversight in clinical research, ensuring the successful execution of major initiatives. This role focuses on designing clinical studies, managing safety protocols, and interpreting complex clinical data to support drug or device approvals.
- How you will contribute:
- * Design and oversee clinical research studies
- * Provide strategic direction and oversight to managers across various functional areas
- * Build and maintain professional relationships with key opinion leaders and stakeholders
- * Interpret complex clinical data to support drug or device approvals
- * Manage safety protocols and address safety issues in clinical trials
- * Ensure project oversight and successful execution of clinical strategies
- * Foster an environment of collaboration and achievement within teams
- As a leader of a sizable (functional) area, serving as the primary internal and external contact for contracts and operations. Your responsibilities include conducting high-level briefings and technical meetings, interacting with managers of equivalent status, and crafting corporate and organizational policies. You will provide strategic direction and oversight to managers across various functional areas, prioritizing the successful execution of major initiatives and ensuring that budgets, schedules, and performance standards are both realistically established and achieved. Your role focuses on strategic impact rather than day-to-day operational involvement.
- Job Posting Description
- The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients' and health care providers' expectations with plasma-derived and plasma-oriented therapies for patients with serious, complex diseases.
- The Medical Director – Hematology, Neuroimunology & Specialty Care (HNSC) leads and drives strategy for the overall global (US/EU/Japan/ other regions and countries) clinical development for Specialty Care products, specifically focusing on development of products targeting indications in Nephrology and/or Transplant Medicine. The candidate will apply their expertise in Nephrology and/or Transplant medicine to clinical development, taking into consideration the medical, scientific, regulatory and commercial perspectives. They will lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility and accountability for development decisions assessing and integrating the input from various disciplines to create and maintain a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical decision making to clinical development processes. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.
- ACCOUNTABILITIES
- Clinical Development team participation and leadership
- Leads nephrology/transplant medicine clinical development for a given product and/or indication, and may represent Clinical Medicine on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.
- Establishes and drives development team strategy and deliverables producing the clinical development strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides 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.
- Responsible for high impact global decisions with respect to nephrology/transplant medicine: 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. Plans clinical 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
- Drives nephrology/transplant medicine clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to assoc. med directors and clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall product strategy
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Trial Medical Monitoring
- Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and products in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
- Makes decisions regarding study conduct related to scientific integrity.
- External Interactions
- Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders in nephrology/transplant medicine relevant to assigned products in PDT R&D. Direct interaction with PIs who are nephrologists or transplant medicine specialists in support of clinical development activities will be required. Provides leadership and serves as an advisor to the others engaged in these activities, and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.
- Due Diligence, Business Development and Alliance Projects
- Responsible for identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
- Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda PDT BU R&D's strategic goals while striving to maintain good working relationship between Takeda PDT BU and partner. Provides guidance to others who are involved in some of these activities.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products. May represent clinical science on high impact/priority task forces across the organization or external to the company. May lead PDT R&D internal teams and global cross-functional teams, as appropriate.
- May hire, manage, mentor, motivate, empower, develop and retain staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning, as appropriate.
- EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- M.D. or internationally recognized equivalent degree is required. Additional advanced degree, e.g. Ph.D. is desired.
- Expertise and significant experience in Nephrology, Transplant Medicine (solid organ or bone marrow transplantation), or related specialty required. Specialty certification in nephrology, transplant medicine, or related specialty is desired.
- 3-5 years of strong clinical research/drug development experience within the pharmaceutical industry is required.
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions is desired. Development experience beyond US/EU is desired.
- Deep medical knowledge and experience in patient care and/or academia and good publication record is desired.
- NDA/MAA Submission experience preferred
- Management experience is preferred
- Knowledge
- Knowledge/experience in Nephrology, Transplant Medicine, or a related specialty, disease mechanisms and plasma derived/related therapies
- Regional/global Regulatory requirements
- GCP/ICH
- Emerging research in plasma derived/related therapies