Senior Medical Director, Redirected Immunity/Cell Therapies

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Job Description

About the role:

Are you looking for a patient-focused company that will inspire you and supports your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Medical Director, Redirected Immunity/Cell therapies at our Cambridge, Massachusetts office or virtually.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. In this interesting role within Takeda’s Oncology Medical Safety team, you will be an integral member supporting the portfolio of cell therapy development programs, being empowered to provide strategic leadership and direction for comprehensive patient safety activities.

This position’s primary role is to enhance the capabilities of the Global Safety Leads (GSLs) and PV Scientists assigned to cell therapy programs in clinical development; you will also act as the product safety expert/GSL for one or more products. You will be an integral part of collaborative programs with academic and research institutions supporting cell therapy programs across various platforms.

You will use your expertise in cell therapy patient safety strategies to provide technical and scientific insight and enable the development and execution of consistent safety assessment and risk management plans, including long-term follow-up. You will also cultivate relationships with cross-functional colleagues and external stakeholders to globally vet and communicate programmatic patient safety risks and ensure risk management activities are scientifically-driven and patient-focused.

The Senior Medical Director will be a key subject matter expert in presentations to executive leadership, including Takeda’s Safety Board, and will contribute to creating a continuous learning environment by identifying, internalizing, and incorporating new trends and methodologies in cell therapies patient safety and benefit-risk management.

How you will contribute:

• Provides technical and scientific expertise to ensure a proactive and integrated approach for identifying, monitoring, and managing cell therapy toxicities and potential patient safety risks.
• Viewed as the subject matter expert in Medical Safety for cell therapy, mentors other PV physicians with respect to safety monitoring and risk management assessment and analysis for compounds in development and marketed products.
• Supports cell therapy collaborative activities, communicating at a senior leadership level the impact of patient safety data in terms of “go/no go” decisions or modification of development plans and/or study designs and the associated impact on development and regulatory timelines.
• Contributes to the development of an integrated signal detection strategy for cell therapy products, including long-term follow-up.
• Reviews and analyzes information from ongoing clinical and non-clinical studies of company and competitor products, discerning scientific and medical implications and making recommendations based on new safety information to ensure the primacy of patient safety.
• In collaboration with Oncology Medical Safety TA Head, ensures adequate resourcing for cell therapy development programs.
• Functions as the Global Safety Lead for one or more cell therapy programs as the portfolio expands.
• Curates a network of expert consultants to assist with the development and delivery of innovative patient safety strategies and evaluation of emerging novel and serious safety signals.
• Represent Takeda Global Patient Safety Evaluation externally through participation in scientific consortia, to promote the development of new tools, methods, and approaches to foster innovation and bring efficiency into product development.
• Contribute to scientific publications and presentations at relevant scientific conferences.
• Supports cross-functional (within and outside Global PV) team evaluations in preparation for Takeda Safety Board presentations as well as having the leadership role for assigned products in safety data presentations to Safety Board.
• Anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues.

Minimum Requirements/Qualifications:

• A medical degree or internationally recognized equivalent is required.
• Direct clinical experience with patients following post-graduate training with an appropriate grounding in and knowledge of general medicine.
• Minimum of 8 years experience in pharmacovigilance, clinical research, or clinical development, including a minimum of 3 years in a global pharmacovigilance organization, preferably in medical safety science.
• Experience working on multidisciplinary clinical projects with cell therapies across various autologous and allogeneic cell therapy platforms (including CAR-T, CAR-NK, TCR, meso, and other cell therapy platforms) is required.
• Understanding of current patient safety concerns and risk mitigation activities associated with the therapeutic and combination therapy landscape.
• Knowledge of regulatory authority requirements regarding immunotherapeutic and cell/gene therapy drug safety and an understanding of general drug safety methodologies.
• A track record of independent critical thinking and scientific achievement demonstrated by national presentations and publications is strongly preferred.
• Proven ability to collaboratively navigate a matrix organization with experience in influencing across multiple areas without direct authority and developing and maintaining key relationships across a broad sphere of influence.
• Ability to work productively and lead in a fast-paced and pressured environment.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• 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 and a company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

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 "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $238,000 to $340,000, based on the candidate's professional experience level. Employees may also be eligible for Short-Term and Long-Term Incentive benefits as well. 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.

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