Manager/Senior Manager, Clinical Pharmacology Lead
Company: CRISPR Therapeutics
Location: Cambridge
Posted on: March 17, 2023
Job Description:
Company OverviewCRISPR Therapeutics is a leading gene editing
company focused on developing transformative gene-based medicines
for serious diseases using its proprietary CRISPR/Cas9 platform.
CRISPR/Cas9 is a revolutionary gene editing technology that allows
for precise, directed changes to genomic DNA. CRISPR Therapeutics
has established a portfolio of therapeutic programs across a broad
range of disease areas including hemoglobinopathies, oncology,
regenerative medicine, and rare diseases. To accelerate and expand
its efforts, CRISPR Therapeutics has established strategic
collaborations with leading companies including Bayer, Vertex
Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is
headquartered in Zug, Switzerland, with its wholly-owned U.S.
subsidiary, CRISPR Therapeutics, Inc., and R&D operations based
in Boston, Massachusetts, and business offices in San Francisco,
California and London, United Kingdom.Position SummaryCRISPR
Therapeutics is seeking a Clinical Pharmacology Lead to join us in
developing novel gene editing therapies for serious diseases. This
position will report into the Clinical Pharmacology Department,
within Clinical Development. The successful candidate will have the
opportunity to manage a portfolio of assays required to execute
clinical trials. This includes translating the needs of the
clinical program into a portfolio of assays, liaising with SMEs for
technical development of assays, responsibility of CRO management,
ensuring timely data delivery in support of clinical trials, data
analysis and summary of data in publication/regulatory submission.
This position requires knowledge of GxP method qualification and
GxP-quality level method validation, and associated documentation
in support of regulatory submissions. Your broad and wide-ranging
experience in managing clinical trials and/or bioanalytical
activities will create engagement and impact for the right
candidate. The desired candidate will demonstrate enthusiasm,
passion, attention to detail, and a desire to create important new
medicines for patients.Responsibilities
- Develop a portfolio of clinical assays and vendor strategies
for CRISPR candidate therapeutics via collaboration with
discovery/pre-clinical scientists, clinical scientists and
commercial vendors
- Propose and manage the development of assays appropriate for
programmatic advancement decisions
- Collaborate with clinical operations and clinical sample
operations to inform domestic and international sample journey
plans and contribute to appropriate clinical laboratory
manuals
- Work with clinical data management and biometrics to ensure
appropriate and timely transfer of data
- Manage vendor and CRO relationships for assay development,
transfer, validation and clinical sample analysis
- Ensure that assay validation and sample analyses are conducted
in line with the appropriate quality and regulatory standards and
guidelines (FDA, EMA, CHMP, WHO, GLP, and ISO).
- Contribute to creation of standards in this new field of
gene-editing based therapies
- Ensure quality and timely submission of all clinical-related
documents and materials for publications, public disclosures,
regulatory filings (such as development/validation reports, SOPs,
sample analyses reports) and also contribute as necessary to IND,
CTA, meeting briefing books, or other requests from global
regulatory authorities.
- Monitor GLP/GCLP quality level method validation of assays at
CROs by providing technical expertise and troubleshooting, as
needed, and review of documents for multiple clinical projects
simultaneously
- Manage critical project and program deadlines
- Effectively communicate results, project progress and technical
challenges to all appropriate team membersMinimum Qualifications
- BS or MS with 3 years or PhD with 1 years of experience in
Clinical Trial Management and/or Bioanalytical Assay
Development/Validation in support of toxicology and clinical trial
activities for early and late stage therapeutic programs
- Working knowledge of bioanalytical techniques, assay
development and validation
- Working knowledge of the principles of clinical trial
operations
- Prior experience working in a biotechnology or pharmaceutical
company coordinating and managing external projects at CROs within
tight timelines
- Excellent oral and written communication skills
- Ability to work independently as well as collaborate with peers
and effectively work in a fast-paced and cross-functional
results-oriented team environment
- Ability to work within tight timelines for successful and
timely execution of project and program goals
- Financial management of projects, including on-time and
on-budget deliverables
- Ability to travel, if required (Approximately 10%)Preferred
Qualifications
- MS degree or higher degree with 5 years of experience in
clinical drug development
- Working knowledge of assay development and validation of
molecular biology techniques, such as, quantitative PCR (qPCR) and
DNA Sequencing (NGS)
- Working knowledge of assay development and validation of
protein biology assays, such as HPLC, ELISA, MSD and Luminex
- Working knowledge of assay development and validation of
immunological techniques, such as multi-parameter flow cytometry
and immunohistochemistry
- Experience working in Cardiovascular and Gene Therapies
- Experience in authoring and reviewing regulatory documentation
for GLP or GCLP quality level projects
- Detailed knowledge of cellular and tumor immunology
principles
- Basic knowledge of gene editing and CRISPR based
technologyCompetencies
- Collaborative - Openness, One Team
- Undaunted - Fearless, Can-do attitude
- Results Orientation - Delivering progress toward our mission.
Sense of urgency in solving problems.
- Entrepreneurial Spirit - Proactive. Ownership mindset.CRISPR
Therapeutics, Inc. is committed to equal employment opportunity and
non-discrimination for all employees and qualified applicants
without regard to a person's race, color, gender, age, religion,
national origin, ancestry, disability, veteran status, genetic
information, sexual orientation or any characteristic protected
under applicable law.To view our Privacy Statement, please click
the following link:
Keywords: CRISPR Therapeutics, Cambridge , Manager/Senior Manager, Clinical Pharmacology Lead, Healthcare , Cambridge, Massachusetts
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