Head of Clinical Biomarkers
Company: Yoh, A Day & Zimmermann Company
Location: Somerville
Posted on: February 24, 2021
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Job Description:
Head of Clinical Biomarkers
LOCATION:
Cambridge MA
Our client is a leading company in cancer genomics driven drug
discovery, delivering on the promise of precision medicine. Now
with three clinical stage anti-cancer molecules in active
development, they are able to uniquely leverage distinct insights
from cancer genomics and real-life patient data to advance its
projects to clinical proof of concept and beyond. They embrace a
novel business model in which it collaborates with another leading
global pharmaceutical company, to create a prolific drug discovery
engine and partnership platform.
They are seeking a senior level scientist/associate director to
lead the Clinical Biomarkers team. As part of the Biomarkers and
Companion Diagnostics group, the clinical biomarkers team is
accountable for developing and delivering of robust,
scientifically-driven biomarker strategies in development programs
for their unique portfolio of precision medicine oncology drugs. As
the head of clinical Biomarkers is accountable for leading a small
team of biomarker scientists and directly providing clinical
biomarker strategy expertise and guidance to some drug
projects.
Principal Duties and Responsibilities
Provide clinical biomarker strategy direction and leadership -
individually and for the clinical biomarker operational team as a
whole.
Develop biomarker strategies and ensuring delivery to oncology drug
project teams following agreed plan.
Manage studies working closely with the Biomarker operations team,
CROs, project teams to deliver biomarker data to support programs
including: 1) Measuring target engagement to inform clinical
decisions for selecting
therapeutically relevant doses and schedules. 2) Understanding key
cancer pathway interactions and feedback mechanisms to guide
rational drug combinations. 3) Generating biomarker data to guide
indication selection and identification of targeted patient
populations. 4) Defining mechanisms of resistance to treatment
Interface with internal functions and external companies to provide
technical guidance in the development of biomarker assays and IVDs
as needed.
Ensure complex clinical assays developed and validated internally
or externally are fit for purpose
Lead the evaluation, validation and implementation of novel
technologies and capabilities both internally as well as at CROs or
external collaborators
Perform analysis of data and summarize results from experiments
performed
Present key results at group meetings and to project teams,
governance bodies and stake-holders
Contribute to and ensure the quality of clinical biomarker study
reports, data reviews and interpretations, presentations,
scientific publications and recommendations to project teams and
client management.
Lead and mentor the clinical biomarker team:
support recruitment and line management of employees, ensuring that
they are appropriately trained, developed and coached to comply
with company and regulatory standards. Actively contribute to the
optimization of existing as well as the development of new
processes to ensure best practice. Mentors and develop Biomarker
scientists and provide feedback to head of the Biomarker and
Companion Diagnostics group, as appropriate, on individual's
performance.
Qualifications
MD, PharmD or PhD in a scientifically relevant discipline with 5-10
years industry or academic experience.
In-depth knowledge of oncology and translational science.
Significant experience working in oncology clinical research.
Experience in molecular biology and/or pathology highly
desirable.
Thorough understanding of all aspects of oncology clinical drug
development, proven experience in strategic planning, proven
ability to understand and critically assess the global clinical
development plans, protocol design, resources needs, budgets and
timelines for programs applicable to clinical biomarker and
companion diagnostic strategy.
Demonstrated leadership, influencing, communication and project
management skills.
Ability to anticipate and solve problems.
Experience and desire to motivate and develop others.
Knowledge of IVD/drug co-development is a plus.
Although not mandatory, previous functional or line management
(coaching, mentoring and developing staff) experience is a definite
plus.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a
protected veteran. Visit
https://www.yoh.com/applicants-with-disabilities to contact us if
you are an individual with a disability and require accommodation
in the application process.PandoLogic.Category: Healthcare,
Keywords: Oncology Director
Keywords: Yoh, A Day & Zimmermann Company, Somerville , Head of Clinical Biomarkers, Healthcare , Somerville, Massachusetts
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