Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Scientist, DMPK 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 Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
OBJECTIVES: The new hire will be part of the Global DMPK department at our Cambridge, MA site. The principal scientist will be responsible for leading DMPK aspect of Rare Disease programs from discovery through clinical development and for establishing mechanistic ADME understanding of gene therapy modality approaches such as AAVs and CRISPR editing. This person will mentor and guide junior scientists within the department in the area of gene therapy ADME.
- Serve as subject matter expert in DMPK of bio-therapeutics and in disposition of gene therapy based protein therapeutics
- Demonstrate experience in leading programs supporting various biologic modalities such as MAbs, enzyme replacement therapies, cell therapies, oligonucleotides
- Establish protocols and methodology to ascertain ADME understanding of AAV and CRISPR-Cas9 protein therapeutics using cutting edge technologies and innovative approaches including consortiums, academic alliances, partnering with internal departments.
- Serve as DMPK project team lead in rare disease programs and liase between team leads and external experts from other departments including program management, discovery biology, toxicology, clinical pharmacology, clinical development, regulatory affairs and other key functions to advance programs from inception to late state clinical development including NDAs
- This scientist will design study protocols, author study reports, DMPK sections of clinical protocols and study reports, global health authority documents such as INDs, IBs, IMPDs, NDAs etc. This individual will also be responsible for responding to pertinent queries and represent DMPK in discussions with global health authorities following filing of INDs, CTAs and other regulatory submissions.
- The individual will use quantitative and in-silico approaches to embrace model-based methodologies to support programs and experimental data derived from gene therapy ADME studies. The individual will provide expertise in pharmacokinetics (PK), pharmacodynamics (PD) and advance modeling approaches such as PBPK and QSP modeling. The individual will also be responsible for translational PK/PD expertise in predicting human dose for FIH studies.
- The individual should have experience adopting an outsourcing approach to conduct studies and hence demonstrate ability to communicate with external vendors, manage timelines and ensure timely delivery of results and data
- Participate and present results in departmental and cross-functional project team and senior management meetings
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- PhD in drug metabolism, cellular biology, biochemistry, genetics or other related field with a minimum of 8 years or MS with a minimum of 12 years of relevant industry research experience and a strong publication record.
- Demonstrated track record as DMPK project lead supporting programs from discovery through late-stage clinical development across both small molecules and biologics is critical. Experience across various biologic modalities is a plus
- Prior experience supporting rare-disease programs is a significant advantage
- Demonstrated experience in authoring global health authority documents and responding to queries is essential
- Must have in-depth knowledge of PK, PK/PD and QSP principles and ability to apply these principles to describe biological processes
- Must have in-depth knowledge and hands-on experience in conduct of AAV / CRISP-Cas9 based pharmacology, PK and PK/PD studies
- Hands-on experience in using qPCR, RT-PCR, ddPCR, ELISA, MSD, Gyros or other novel analysis methodologies for bio-therapeutic molecules
- Hands-on experience in using PK and modeling platforms such as Phoenix, MATLAB, NONMEM, Simbiology, R, Simcyp is essential
- Ability to articulate and establish processes that have cross-functional impact and drive decision-making within a cross-functional team structure
- Excellent organization skills and multi-tasking ability
- Highly effective presentation skills
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
Empowering Our People to Shine
Discover more at takedajobs.com
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