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Location

New Jersey | United States

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Job description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary

To succeed as global pharma innovator in oncology, a therapeutic area known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global drug portfolio from the Research stage to post marketing/lifecycle management. Our expectation is that the person filling this role will pioneer and eventually lead a new group within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact a proactive safety strategy at the start of Phase 1. He/she will remain involved throughout development and, ideally, post marketing, providing teams with expert advice and/or access to external expertise for novel safety issues requiring safety surveillance and/or risk mitigation.

Responsibilities

- Research and Nonclinical Development: For select drug candidates, especially ones addressing new targets or associated with new risks or linked to new risks, provide safety knowledge and input to Research in Tokyo based on the MOA and initial toxicological profile. Provide a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. Offer leadership on validating such biomarkers if needed. In general, deliver a proactive safety strategy for such candidates by the start of the FIH trial (DP1).
- Clinical Development and Post Marketing: Consult with PSLs/GPTs on management of potential and identified risks for select products during development. Assist teams in maintaining oversight of changes to the benefit/risk balance. Provide expert input on surveillance, assessment and mitigation of changes to the risk profile or emerging risks during exposure to subjects and patients. Maintain latest knowledge on key safety topics impacting the DS global pipeline. Provide CSPV leadership on safety-related biomarkers that might be leveraged throughout development and during post marketing. Serve as a bridge to Nonclinical Development on clinical safety findings, particularly ones likely to require additional nonclinical safety assessments.
- Collaboration and relationship building with key stakeholders: Foster the enhancement of an integrated safety culture from Research to postmarketing/lifecycle management. Create a working CSPV relationship with Research based in Tokyo. Grow CSPV’s connection to toxicology (MSRL) and Precision Medicine beginning at the start of preclinical development. Oversee existing DDiS collaboration with MSRL. Become a go to contact for PSLs and GPTs for less typical safety issues where monitoring and management pathways are poorly defined or undefined. Mentor junior CSPV physician staff on translational safety topics. Grow and maintain connections with external safety experts focused on translational safety and safety biomarkers. Participate in relevant scientific collaborations.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

-MD MD or PhD required with in depth clinical experience required

 

Experience Qualifications

-10 or more years of relevant experience in pharmacovigilance and related fields defined here required.
-7 or more years of experience within pharmacovigilance, clinical pharmacology, preclinical research, toxicology and/or biomarker validation (especially in industry) required.

Travel

Must have the ability to travel up to 10% domestic and international

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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