Posted to MedZilla on 5/21/2019


Takeda Pharmaceuticals

US-CA, Medical Director/ Senior Medical Director, Translational Medicine Neuroscience (NS) R0007056-MZ


 
 

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Job Description

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

Medical Director/ Senior Medical Director, Translational Medicine Neuroscience (NS) in our San Diego, CA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES:

  • To provide a key fulcrum of bidirectional Translational Research and Experimental Medicine (TREM), bridging the Neuroscience Drug Discovery Unit (DDU) and Therapeutic Area Unit (TAU)
  • To facilitate a seamless transition of assets through the Takeda s Neuroscience (Neurology / Psychiatry) R&D portfolio, through deep engagement in discovery and seamless transition between discovery/ preclinical into early clinical research
  • To lead Translational Strategy Teams (TST) consisting of other Research and Clinical scientists to develop a Translational Research Plan (TRP), including design and oversight of preclinical and translational studies that will best inform clinical development
  • To lead execution of the Translational Research Plan as part of the overall Asset Strategy in the Global Project Team
  • To design and execute Experimental Medicine ( Phase 0 ) clinical studies to establish human models that will accelerate quantitative, disciplined Go/NoGo decisions earlier in development
  • To advise Global Project Teams and Clinical Subteams on execution of biomarker-driven Early Proof-of-Concept (EPOC) studies, based on the TRP and adoption of EM models
  • To lead matrixed platform functions in development of biomarker platforms across modalities (Molecular, Imaging, and Neurocircuitry) that align with NS portfolio and specific project team needs
  • This role embraces the principles of a translational/exploratory mindset, with a focus on deep scientific rigor and operational excellence

ACCOUNTABILITIES:

  • Acts as a key interface between the NS Drug Discovery Unit (DDU) scientists and Therapeutic Area Unit (TAU) clinicians to ensure portfolio prioritization and seamless transition of programs between research and clinical development
  • Translational Medicine Lead (TML) on the Global Project Team (GPT), leading development and execution of the Translational Research Plan as part of the overall Asset Strategy
  • Drive projects to rigorous assessments of therapeutic success or failure by testing clear scientific hypotheses as early, leanly, directly, and quickly as possible in the preclinical, translational, and experimental medicine stages of development
  • Engages early (at Project Start and more intensively at lead optimization stages) with basic research colleagues to advise on translational strategies and inform portfolio prioritization
  • Provides Translational Medicine expertise and recommendations to DDU on Go/No-Go decisions at candidate decision gates
  • Leads the Translational Strategy Team (TST) bridging Research Project Teams to Global Project Teams (GPTs) to support molecular biomarker, imaging, neurocircuitry biomarker (electrophysiology / cognitive/behavioral / digital measures), and/or pharmacogenomic strategies and implementation
  • Works closely with functional experts within Quantitative Translational Sciences (QTS) to ensure quality of the TRP and delivery of program-specific biomarkers and portfolio-relevant novel platforms
  • Engages NS TAU clinicians, Regulatory, and Commercial leads during TRP creation to ensure Translational Medicine studies support decision-making for late phase development.
  • Designs and implements clinical protocols for Experimental Medicine studies to test novel biomarkers and study designs in order to support earlier decision-making in development
  • Contributes to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as needed as well as co-authored publications in scientific journals
  • Ensures agile, timely management of issues arising from ongoing studies, including serving as the study physician for adverse event reporting
  • Works closely with Clinical Operations, Procurement, and Legal functions to support clinical study implementation of Experimental Medicine studies
  • Provides Translational Medicine expertise for external opportunities, including participation in due diligence teams

EDUCATION, BEHAVIORAL COMPETENCIES, AND KNOWLEDGE/SKILLS:

Education, Experience

  • MD, MD/PhD preferred
  • Formal clinical training, including fellowship training with NS specialization, preferably Psychiatry
  • Clinical development and/or translational/ experimental medicine expertise strongly preferred
  • Clinical development experience should be in academia and/or industry, including early clinical trial design and implementation, documentation / filing
  • Discovery/basic research experience is preferred
  • Academic clinical experience is preferred
  • Rigorous record of scientific publication is required
  • Minimum 3-10 years biopharmaceutical/CRO health-related consulting company/academic industry early clinical development experience
  • Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to late-stage development

Behavioral Competencies

  • Driving results is essential. Need to be able to motivate individuals in a cross-functional, matrixed organization and project team setting, to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback.
  • Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision.
  • Planning, priority-setting, and time management are essential.
  • Accountability takes responsibility for his or her own performance and accepts full ownership of issues, problems, and opportunities, regardless of the source.
  • Comfort with ambiguity is required.
  • Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others' ideas.
  • Excellent communication, interpersonal sensitivity, and negotiating skills
  • Team-work, partnership and collaboration skills

Knowledge/Skills

  • Neuroscience-related clinical expertise
  • Basic and clinical science of neuroscience pathophysiology
  • Translational medicine, including biomarkers
  • Nonclinical and clinical drug discovery and development
  • Regional/Global Regulatory requirements
  • GCP/ICH

EDUCATION, LICENSES, CERTIFICATIONS:

  • Medical degree required
  • MD-PhD preferred
  • Board certification preferred

TRAVEL REQUIREMENTS:

  • Position based in San Diego, CA
  • Ability to drive or fly to various meetings or client sites, including overnight and international travel
  • Up to 20% travel time required.

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

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

*LI-CS1

Locations

San Diego, CA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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