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Director, Pharmaceutical Sciences Program Leadership

Boston, Massachusetts
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  • Job Level: Senior
  • Travel: 5-10%

The Pharmaceutical Sciences (Pharm Sci) organization is an integral part of global R&D at Takeda, translating science into therapeutic products for patients. When you join Pharm Sci, you become part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent while minimizing environmental impact.

We work as a member of Takeda’s Global Program Team (GPT) and take full ownership of Chemistry, Manufacturing & Control (CMC) activities — driving product development from bench to bedside.

The Pharm Sci team focuses on executing and enhancing business processes and partnering with key stakeholders and industry leaders to boldly deliver an increasingly complex portfolio. Always looking through a sustainability lens to protect our planet, we are embracing new ways of working, excelling in our data and digital transformation, building differentiated capabilities (CMC Acceleration), delivering innovative medical devices, and advancing an inclusive, innovative culture.

It is an exciting time to be in Pharm Sci. Join our journey and change the lives of patients!

Job ID R0135372 Date posted 09/26/2024 Location Boston, Massachusetts

By 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’sPrivacy Noticeand 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

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.

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Takeda Compensation and Benefits Summary

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:

Boston, MA

U.S. Base Salary Range:

$169,400.00 - $266,200.00

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. U.S.based 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. U.S.based 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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Where you fit in

Our teams are experienced in medicinal chemistry, multi-step synthesis, multimodal genetics, genomics datasets, pharmacokinetics and more. So wherever your expertise and passion lie, your work will have tangible outcomes, advancing an innovative pipeline that serves unmet needs.

We're delving deeper than ever inside the human body and its microbiome, implementing innovative approaches to deliver high-quality products that treat a range of illnesses, including IBD and cancer.

In our diverse, forward-thinking culture, we're constantly embracing new ways of working:

  • Partnering with research teams, GPTs, business development and our commercial partners in GMS/GQ
  • Supporting all stages of pre-clinical and clinical development
  • Providing enabling technologies, including formulation and delivery strategies, analytical expertise and IP
  • Developing processes to manufacture high-quality Clinical Trial Material and other
  • Focusing on broad therapeutic areas on multiple device platforms: Advanced Delivery Devices, Home & Point-Of-Care Diagnostics, Software & Connectivity for eHealth devices and state-of-the-art Medical Devices & Combination Products

On our team in Pharmaceutical Sciences, you’ll notice a big difference in your own life, too. You’ll be supported to develop your career. You'll connect with brilliant minds and be recognized for your accomplishments. Your curiosity, skills and dedication will have a place and a purpose. So even when you’re exploring the smallest of details, your world will be bigger than ever.

  • Perform cell processing operations

  • Support clean room activities

  • Ensure equipment maintenance

  • Support investigations in deviations

Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.
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The heart of our work

Leading with innovation

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Boston, Massachusetts


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