Global Translational Lead, Hematology-Oncology

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 Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Global Translational Lead in our Cambridge office.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 : The Oncology Global Translational Lead (GTL) role is an exciting opportunity within the growing Precision and Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) at Takeda. This is a highly visible, strategic, and matrixed role that leads, and is accountable for the Translational Subteam of the Global Program Team (GPT). The GTL develops and drives translational impact from strategy development through insight generation. GTLs are strong scientific leaders, with extensive drug development experience combined with exceptionally strong matrix leadership and communication skills. This role will partner closely with key functions across Takeda Oncology including Clinical, Drug Discovery, Clinical Pharmacology, Companion Diagnostics, Global Regulatory Affairs, Biomarker Sciences and Technologies, Global Medical Affairs, and Commercial. We are currently looking for a GTL to develop and deliver program level translational strategy for late clinical oncology development programs in the hematology oncology space (e.g. myelodysplastic syndromes and myelofibrosis). This role reports to the Head of Oncology Precision and Translational Medicine.ACCOUNTABILITIES : Develop and deliver overarching program level translational strategy as a core member of the Global Program Team (GPT). Represent translational medicine at internal governance meetings.Ensure broader program level scientific translational objectives and plans are developed to advance the program and help better position the program for success.Ensure that robust translational hypotheses are assessed, including evaluation of predictive and patient segmentation biomarkers, development of indication selection and expansion strategies, and contribute to publication strategy and commercial differentiation efforts.Gain internal and external stakeholder input and alignment on the program level translational strategy.Communicate translational status updates for key deliverables to OTAU and other Takeda leaders as needed.Identify translational issues and resources needs, develop solutions, and escalate to the broader organization as needed for resolution.Lead the translational medicine sub-team of the GPT comprised of key internal drug development functions and partners (clinical, clinical biomarkers, biomarker technologies, bioinformatics, statistics, drug discovery, diagnostics, project management) to develop and deliver program and study level translational strategy.Accountable for clinical biomarker plans and work closely with and also mentor study-focused Clinical Biomarker Leads who support biomarker strategy, data delivery, analysis and interpretation in partnership with the GTL. Review and provide input into clinical protocols, informed consent forms, IBs, clinical study reports and other related documents as needed.Partner with Medical Affairs to develop and integrate translational data into program level publication, investigator sponsored research, and communication strategies.Partner with Commercial to integrate translational elements into the target product profile and launch plans.Partner with Regulatory Affairs and ensure appropriate biomarker elements are incorporated with rigor into BLA and NDA filings with health authorities, works closely with the program team to respond to health authority questions or requests for information; may participate in health authority meetings as needed.EDUCATION AND EXPERIENCE : PhD and / or MD in cancer biology, immunology, genetics, pathology, or related field with 8 years of experience in pharmaceutical or biotech R&D. MS or BS with 12 years of research and development experience with progressive levels of team leadership also considered.Preference for those with 5 years experience as a Translational lead for clinical programs. Experience with Ph2 / 3 or registrational programs desired.Oncology and / or immunology experience with demonstrated focus on hematology oncology malignancies. Strong knowledge of hematopoiesis and experience in MDS / MPN / MF preferred.Experience developing and delivering translational and biomarker strategies for late stage (Ph2 / 3 and registrational) clinical programs.Experience developing and testing translational hypotheses, interpreting biomarker data in clinical studies.Excellent understanding of drug development, regulatory processes and clinical development.Strong leadership abilities and proven ability to lead a team within a matrix organization as well as able to work independently and be proactive.SKILLS : Excellent communication (written and oral) skills.Excellent strategic, interpersonal, influence, and negotiating skills.Demonstrated ability to work effectively across functions, projects, and time zones.Ability to assemble and motivate cross functional stakeholders and drive results.Capable of proactively predicting issues and solving problems with agility.Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.Ability to drive multiple priorities forward simultaneously.Ability to lead / work successfully in hybrid virtual team setting as team members may be located in multiple buildings / cities.Strong scientific and research skills to be able to review / analyze / interpret internal and external data (translational, biomarker and clinical) and to compile insights on competitive landscape and understand potential impact on evolving program strategies.TRAVEL REQUIREMENTS : Ability to drive to or travel to conferences, partner meetings, including overnight trips. Some international travel may be required.Requires approximately 10 - 15% travel.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.This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.Locations Boston, MAWorker Type EmployeeWorker Sub-Type RegularTime Type Full timeJob Exempt : Yes#J-18808-Ljbffr