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Associate Director Translational Biomarker Research - Oncology

Location
Cambridge, MA

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Job Description:
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice
, Privacy Policy
and Terms of Use
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 an Associate Director, Translational Biomarker Research - Oncology
 in our Cambridge
office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.  As an  Associate Director 
working on the Translational Biomarker Research - Oncology
 team, you will be empowered to lead the biomarker strategy
and a typical day will include:  
POSITION OBJECTIVES:
This position is an acknowledged technical and strategic expert whose primary role is to provide scientific leadership, research planning and decision making from Pre-Candidate Nomination (CN) through Proof of Concept (PoC) and Late Stage Clinical testing, for smaller global or large regional compounds relevant to their therapeutic area for biomarker discovery and clinical development. Responsibilities include partnering with DDU scientists and research project teams to identify biomarkers relevant to clinical patients, providing scientific expertise to generate clinical development strategies including clinical biomarkers in collaboration with the Translational Research Network for the Global Product and/or Early Development Teams. These strategic goals include implementation of pharmacodynamic biomarkers indicating  target engagement, hypotheses for patient enrichment and feedback of clinical patient data to DDU. Takes the lead in keeping up-to-date on, and providing scientific expertise regarding, non-clinical and early clinical biomarker identification and translational pharmacology initiatives.  
POSITION ACCOUNTABILITIES:
Collaborate with  medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy.Part of the team that provides strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated translational research strategy for assigned program(s).
Partner with DDU scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response. Participate in  the collaborative interactions between Early Clinical Development and DDU researchers in Shonan Research Center, Takeda California, Takeda Cambridge and Takeda Singapore to facilitate generation and implementation of early clinical development strategies.
Represent Translational Research on Global Product Teams (GPT) working groups to contribute to the dose and biomarker selection for first-in-human studies, provide pharmacologic and pharmacodynamic rationales and translational/experimental medicine approaches for early clinical protocols.
Participate in the design and implementation of biomarker research in clinical trials and monitor the scientific quality of pharmacodynamic and predictive biomarker clinical assay data
 Maintain extensive knowledge of the research and development efforts from academic institutions, competitor pharmaceutical companies and fee-for-service bioanalytical companies for relevant oncology biomarkers.
Evaluate, and use 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 and documents submitted to Regulatory Agencies for smaller global or larger regional assigned 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. Establish and maintain scientific dialog with clinical translational experts in medical, academic and regulatory communities.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:  
Ph.D 10 years, or PharmD 12 years, or Masters 13 years or Bachelors 15 years Degree is expected in relevant scientific area, e.g., Oncology, Immunology, Neurobiology, Endocrinology, Pharmacology, Biochemistry, Molecular Biology, Cell Biology.
More than 75 years of relevant industry experience in translational research and assay development
Recognized expertise in Biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations
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
TRAVEL REQUIREMENTS:
25% National and International travel.
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
Learn more at takedajobs.com
No Phone Calls or Recruiters Please.
#LI-MB1
Locations
Cambridge, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Apply Now
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence
and that I agree with
Takeda’s
Privacy Notice
, Privacy Policy and Terms of Use .
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 an Associate Director, Translational Biomarker Research - Oncology  in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.  As an  Associate Director  working on the Translational Biomarker Research - Oncology  team, you will be empowered to lead the biomarker strategy and a typical day will include:  
POSITION OBJECTIVES:
This position is an acknowledged technical and strategic expert whose primary role is to provide scientific leadership, research planning and decision making from Pre-Candidate Nomination (CN) through Proof of Concept (PoC) and Late Stage Clinical testing, for smaller global or large regional compounds relevant to their therapeutic area for biomarker discovery and clinical development. Responsibilities include partnering with DDU scientists and research project teams to identify biomarkers relevant to clinical patients, providing scientific expertise to generate clinical development strategies including clinical biomarkers in collaboration with the Translational Research Network for the Global Product and/or Early Development Teams. These strategic goals include implementation of pharmacodynamic biomarkers indicating  target engagement, hypotheses for patient enrichment and feedback of clinical patient data to DDU. Takes the lead in keeping up-to-date on, and providing scientific expertise regarding, non-clinical and early clinical biomarker identification and translational pharmacology initiatives.  
POSITION ACCOUNTABILITIES:
Collaborate with  medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy.Part of the team that provides strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated translational research strategy for assigned program(s).
Partner with DDU scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response. Participate in  the collaborative interactions between Early Clinical Development and DDU researchers in Shonan Research Center, Takeda California, Takeda Cambridge and Takeda Singapore to facilitate generation and implementation of early clinical development strategies.
Represent Translational Research on Global Product Teams (GPT) working groups to contribute to the dose and biomarker selection for first-in-human studies, provide pharmacologic and pharmacodynamic rationales and translational/experimental medicine approaches for early clinical protocols.
Participate in the design and implementation of biomarker research in clinical trials and monitor the scientific quality of pharmacodynamic and predictive biomarker clinical assay data
 Maintain extensive knowledge of the research and development efforts from academic institutions, competitor pharmaceutical companies and fee-for-service bioanalytical companies for relevant oncology biomarkers.
Evaluate, and use 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 and documents submitted to Regulatory Agencies for smaller global or larger regional assigned 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. Establish and maintain scientific dialog with clinical translational experts in medical, academic and regulatory communities.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:   Ph.D 10 years, or PharmD 12 years, or Masters 13 years or Bachelors 15 years Degree is expected in relevant scientific area, e.g., Oncology, Immunology, Neurobiology, Endocrinology, Pharmacology, Biochemistry, Molecular Biology, Cell Biology.
More than 75 years of relevant industry experience in translational research and assay development
Recognized expertise in Biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations
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
TRAVEL REQUIREMENTS:
25% National and International travel.
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 Learn more at takedajobs.com . No Phone Calls or Recruiters Please. #LI-MB1
Locations
Cambridge, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time >
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