About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, Pharmaceutical Sciences Program Leadership where you will be responsible for implementing Pharmaceutical Sciences' Research to Development operating model on a program-specific basis and timely fulfillment of Pharmaceutical Sciences deliverables to IND. You will also lead late-stage programs as needed. As part of the Pharmaceutical Sciences Early-Stage Portfolio team, you will report to Pharmaceutical Sciences (CMC) Early-Stage Portfolio Leader and mentor and cultivate best practices in the Functional PS-Lead global community.
How you will contribute:
- Support the Functional PS-Lead community of preclinical assets up to IND across multiple modalities, therapeutic areas, and regions (US, JP, EU).
- Deliver excellence in leadership, CMC strategy development, and implementation of the strategy in alignment with Research/Global Project Teams (RPTs/GPTs), Drug Development Units (DDUs) and Research goals/KPIs.
- Active across both internal and external assets and excellence in communication of CMC risks to various stakeholders including executive management.
- Independently leads development of strategy and plans for multiple, complex programs.
- Lead and influence functional/divisional strategy, operations and innovation.
- Impactful contributor to divisional initiatives and may contribute to corporate, cross-divisional, and global initiatives.
- Mentor early-stage functional PS-Leads, with an emphasis on balancing the uniquely fluid and rapid nature of Research programs while ensuring key Pharmaceutical Sciences interests are represented at the project team level. Develop their abilities to lead and advance their individual skills of pharmaceutical product development.
- Provide guidance to early-stage functional PS-Lead in the preparation and review of critical governance documents and other deliverables for each program, including Portfolio Review Committee (PRC) Narratives, Candidate Quality/Developability Assessments, CMC Strategy Review Board materials, etc.
- Build relationships with key partners to gain understanding to deliver on early-stage program goals.
- Provide strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require scientific depth and overall product development acumen for successful execution.
- Identify, mitigate and communicate project or program risks to relevant stakeholders. This person is expected to advance not only the program teams they lead but also other teams that are facing unique challenges.
- Lead/participate as functional expert in divisional and cross-divisional initiatives.
- Represent CMC on cross-divisional governance and development teams while providing strategy and accountability for CMC deliverables.
- Lead training of early-stage functional PS-Leads on key elements of Pharmaceutical Sciences Playbook, specifically the R2D operating model and deliverables to IND.
- Provide scientific leadership and innovation in pharmaceutical research and development. Build teams across functions and geographies with individuals who have the right skills and experience to achieve key organizational initiatives.
- Be an internal consultant to the Pharmaceutical Sciences staff for any scientific advice that may be needed on a project basis.
- Represent Pharmaceutical Sciences in cross divisional, corporate and global initiatives. Cultivate a broad network of relationships throughout Takeda, with affiliates and alliance partners, in the industry and area of expertise.
- Develop and communicate convincing business cases for department strategies that motivate stakeholders to take action.
- Ensure that technical and scientific standards within the function meet state-of-the-art industry expectations.
- Identify, evaluate, develop, recommend and/or negotiate novel solutions to meet critical project needs.
- Critically review technical and scientific reports from external sources and coordinates Takeda-sponsored work.
- Develop and use knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program, divisional and corporate goals and objectives; able to lead in a highly dynamic environment and where CMC information is often limited; adapts well to different personalities and manages others on the team in a respectful manner. Ability to lead in a matrix environment to influence without formal authority of stakeholders.
- Identify/solve technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies. Ability to identify gaps in CMC technology/trends and influence change/improvements to affected areas/processes.
- Anticipate and manage internal and external resource needs (people, information, technologies, time, and capital). Proactively seek opportunities for improvement and creativity during early- and late-stage development.
- Exercises good time management and prioritization skills to balance multiple project and departmental objectives; sets aggressive yet realistic plans based on project strategy.
Minimum Requirements/Qualifications:
- BS + 18 years; MS + 14 years; PhD + 12 years
- Experience working in a multi-disciplinary team environment, previously served as a member of multiple PS-Teams or as a PS-Lead (preferred).
- Ability to propose and influence development to result in a successful FIH filing and a commercially viable product.
- Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions.
- Experience must be in a scientific discipline in at least one modality with expert knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work. Regularly contributes functional expertise to external industry and advocacy groups. Willingness to learn other modalities.
- Must demonstrate knowledge of several allied fields, such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Advanced understanding in DMPK, Pharmacology and Toxicology.
- Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies.
- Must have experience in global regulatory submission requirements and processes.
- Strong program management skills and experience in teaching/mentoring required.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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