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’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout 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, Precision Medicine and Digital Health where you will be responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support the development of biomarkers, diagnostic tests, devices, and digital health tools to enhance the value of our products across therapeutic areas.You will also establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests, and digital tools to ensure goals/objectives are met.How you will contribute:
You will be responsible for overseeing the precision medicine and digital health efforts for assigned programs.
Ensure global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
Ensure line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner. Demonstrate ability to anticipate risks and be responsible for developing solutions to identified risks and discussing with direct reports and management; understand probabilities of technical success for the solutions.
Effectively represent the Global Regulatory Affairs (GRA) function in senior-level interactions at internal governance technical review committees, key global health authority meetings, and external partners.
Participate with influence in or lead departmental and cross-functional task forces and initiatives. Influence non-direct reports within the therapeutic area, across GRA, and the enterprise.
Provide regulatory strategy support to diligence for licensing opportunities as appropriate
Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
Identify regulatory requirements and provide regulatory guidance, and expertise to the global development team on the assigned project(s) of responsibility.
Minimum Requirements/Qualifications:
Scientific background, PhD., M.D., PharmD, MS
A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 8 years of regulatory and/or related experience.
Expert knowledge of device development, registration and maintenance regulations with experience in championing innovation in technical areas.
Comprehensive understanding of biomarker strategies and implications for drug development.
Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
Understand scientific principles and regulatory Device requirements relevant to global drug development and post-market support, including recent EU MDR and IVDR.
Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provide knowledge and expertise to guide the team in establishing and building appropriate global regulatory strategies.
Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions.
Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills. You will have a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
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
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 : $165,200.00 to $236,000.00, based on candidate 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. 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.#LI-AA1#LI-RemoteEEO StatementTakeda 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.LocationsUSA - MA - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote
