Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Associate Scientific Director/Director Translational Neurophysiology in our Cambridge office.
H ere, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Associate Scientific Director/Director Translational Neurophysiology title
working on the Translational Research Early Clinical team, you will be empowered to apply your scientific expertise for the clinical development of CNS drugs : POSITION OBJECTIVES:
This position seeks an acknowledged translational and neurophysiology technical and strategic scientific expert with a strong Neuroscience background and experience in the use of electrophysiology tools for clinical development of CNS drugs. The primary role is to provide translational and biomarker leadership as well as research planning and decision making from pre-candidate nomination through Proof of Concept (PoC) and Late Stage Clinical testing, for biomarker strategy, discovery and development in the CNS therapeutic area. Responsibilities include partnering with drug discovery scientists and project teams for identification and implementation of neurocircuitry engagement biomarker studies, identifying and arranging the internal or external resources for those studies, and coordinating analyses and presentation of the data. The candidate will also serve as an internal E-Phys design and implementation expert for consultation with other functions, such as late-stage project teams in the CNS therapeutic area. The scientist will also take the lead in keeping up-to-date on, and providing scientific expertise regarding, non-clinical and early clinical biomarker identification and electrophysiology and translational pharmacology initiatives. POSITION ACCOUNTABILITIES:
Qualifications: EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
- Provide strategic, technical and scientific leadership for electrophysiology biomarker development.
- Lead scientific discussions with clinical medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy Synthesize large amounts of complex data to build an integrated translational research strategy for assigned program(s).
- Partner with drug discovery scientists to design and execute translational research to discover and validate pathways and biomarkers associated with circuit engagement, mechanism of action and drug response. Lead the collaborative interactions between early clinical development and drug discovery researchers to facilitate generation and implementation of early clinical development strategies.
- Situational leadership of Global Product Teams (GPT) in the neurophysiology biomarker selection for first-in-human studies, provide pharmacologic and pharmacodynamic rationales and translational approaches for early clinical protocols.
- Oversee the design and implementation of neurophysiology biomarker research in clinical trials and monitor the scientific quality of electrophysiology clinical assay data
- Represent Takeda nationally and internationally when working with academic institutions, competitor pharmaceutical companies and fee-for-service bio analytical companies in the field of translational and biomarker research.
- Identify, evaluate, develop and communicate/negotiate criticality of new scientific tools for effective and thorough non-clinical and early clinical programs and ensure that technical and scientific standards meet state-of-the-art industry expectations.
- Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols, clinical study reports, biomarker reports and documents submitted to Regulatory Agencies for large global or complex regional compounds.
- Support Business Development efforts by evaluating potential in licensing opportunities and serve as a liaison with external companies, organizations, consultants, university representatives, NIH, and with FDA, as required. Actively manage and participate in industry and academic consortia
- Establish and maintain scientific dialog with clinical translational experts in medical, academic and regulatory communities.
- Ph.D + 12 years, PharmD +15 years, is expected in CNS scientific area.
- More than 10 years of relevant experience in translational neurophysiology research and at least 5 years of industry experience.
- Recognized expertise in Neurophysiology techniques development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations
- Experience/knowledge base in neuropsychiatric and neurological disorders
- Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of translational research strategies implemented in early clinical programs in a timely manner
- An understanding of PoC and PoM clinical concepts and trial design
- Should serve as a “highly credible technical expert” to outside functional areas
- Excellent understanding of drug development, regulatory processes and early clinical development
- Strong leadership abilities and proven ability to lead a team within a matrix organization as well as work independently
- Superior analytical, problem solving skills
- Extraordinary oral and written communication skills
- Exceptional interpersonal skills
WHAT TAKEDA CAN OFFER YOU:
- 20% National and International travel.
Empowering Our People to ShineLearn more at takedajobs.com . Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx No Phone Calls or Recruiters Please.
- 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
A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.