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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
OBJECTIVES/PURPOSE
- The Associate Director, CMC Program Lead in Allogeneic Cell Therapies is responsible to collaborate across Cell Therapy CMC functions and RA functions to deliver pipeline projects.
- The role sits within Cell Therapies CMC team and is a highly visible matrix leadership role accountable to broader program and functional stakeholders through Cell Therapy program and technical team structures to support the strategy and execution of CMC activities in scope for a given project.
- Success in this role depends heavily on strong cell therapy development experience, broad technical understanding of core and extended CMC functions, strategic thinking, keen problem-solving abilities, excellent leadership skills, and a proven ability to influence in a matrix environment.
ACCOUNTABILITIES
- Lead a CMC matrix teams to deliver Cell Therapy pipeline projects
- Drive strategy development and lead execution of all phase-appropriate CMC activities in scope for given project (e.g. supporting program regulatory filings, critical cross-functional capability building, etc)
- Represent CMC team in technical, program and governance discussions
- Escalate issues, risks with recommended mitigation strategies across CMC line functions and per program governance procedures
- Leverage project management best practices to develop and communicate plans and risks to all stakeholders
- Maintain broad awareness of global regulations and industry practices for the development of cell therapies spanning phase-appropriate pre-clinical and CMC studies
- Develop a culture of transparency, accountability, high cross-functional communication, and timely execution within the project CMC team
- Periods of significant travel required depending on specific project needs
Technical/Functional (Line) Expertise
- Must have a degree in a scientific discipline. BS with at least fifteen (15) years, MS/PharmD with at ten (10) years or a PhD with at least five (5) years of drug development experience in the pharmaceutical industry
- Experience in CMC and Cell Therapies strongly desired, including allogeneic therapies
- Leadership skills combined with excellent communication skills and the ability to positively influence colleagues, key decision makers. Demonstrated ability to work well and manage personnel in a highly cross-functional team environment.
- Ability to work independently and collaboratively, along with good organizational skills, and able to drive multiple projects to successful, timely completion in a fast-paced, global environment.
- Must have demonstrated experience and aptitude in preparing and supporting Chemistry, Manufacturing and Control (CMC) documentation enabling early clinical development (e.g. IND’s)
- Must have experience in pharmaceutical drug development and the regulatory submission process
- Leadership skills combined with excellent communication skills and the ability to positively influence colleagues, key decision makers. Ability to work well and manage personnel in a highly cross-functional team environment.
- Independently manages workload and expectations
- Represent Cell Therapies CMC team in technical, program and governance discussions
- Teamwork – Ability to work well in a highly cross-functional team environment
- Working with cross-functional teams and ability to align, motivate, and empower team members. Ability to work well in a highly cross-functional team environment
- Communication - Able to express one’s self clearly and concisely within team; documents issues and/or concerns concisely; timely and effectively communicates issues to supervisor and team members
- Critical thinking and problem-solving skills and ability to articulate and drive risk-based decision making
- Leading cross-functional teams and drive global CMC strategy
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Must have a degree in a scientific discipline.
- BS with at least fifteen (15) years
- MS/PharmD with at ten (10) years
- PhD with at least five (5) years of drug development experience in the pharmaceutical industry
- Experience in CMC Cell Therapies, including allogeneic therapies
- Leadership skills combined with excellent communication skills and the ability to positively influence colleagues, key decision makers. Ability to effectively influence, build relationships and make recommendations at all levels of the organization. Demonstrated ability to form, lead, manage and negotiate cross-functional and cross-regional teams.
- Ability to work independently and collaboratively, good organizational skills, and able to drive multiple projects to successful, timely completion in a fast-paced, global environment.
- Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
- Must have demonstrated experience and aptitude in preparing and supporting Chemistry, Manufacturing and Control (CMC) in Cell Therapies documentation enabling in early clinical development (e.g. IND’s)
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.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Base Salary Range:143,000 to 205,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Empowering Our People to Shine
Discover more at takedajobs.com
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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.
Boston, MA
Employee
Regular
Full time