Vice President, Bioanalytics and Developability
Company: Larimar Therapeutics
Location: Thorofare
Posted on: May 28, 2023
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Job Description:
Description:Larimar Therapeutics Inc (Bala Cynwyd, PA) is a
clinical-stage biotechnology company focused on developing
treatments for complex rare diseases. Larimar's lead compound,
CTI-1601, is being developed as a potential treatment for
Friedreich's Ataxia. Larimar also plans to use its intracellular
delivery platform to design other fusion proteins to target
additional rare diseases characterized by deficiencies in
intracellular bioactive compounds. The Vice President will report
into Larimar's Chief Development Officer and shall be a member of
the R&D senior leadership team. The incumbent will provide
strategic leadership as well as hands-on individual contributions
to Larimar's portfolio projects, specifically imparting deep
scientific and technical expertise in large molecule/biologics
assay development, optimization, qualification, and validation. The
Vice President will play a leading role in developing and executing
the preclinical and clinical bioanalytical strategies, designing,
overseeing, interpreting and troubleshooting studies, and
developing immunogenicity risk assessments and biomarker plans in
support of Larimar's rare disease portfolio. They will ensure the
function's completion of planned analytical activities in
accordance with corporate goals, scope, timing, and budget to drive
project success. In this role, the incumbent will be expected to
contribute to Larimar's R&D from bench-to-bedside, i.e., from
early discovery through late-stage clinical studies, and may have
the opportunity to lead R&D Program teams.The candidate should
have proven industry experience supporting nonclinical and clinical
drug development programs, including strong collaborations with
external contract research organizations (CROs). The candidate
should be a highly organized, engaged contributor, with strong
leadership skills demonstrated through prior lead roles in the
management of bioanalytical teams and personnel. This job offers
hybrid work flexibility with requirement to work on-site at least
2-3 days per week.This is an exciting opportunity to be part of a
passionate, high-impact R&D team in a highly dynamic and
collaborative setting of an entrepreneurial, fast-paced,
biotechnology company. Job Duties/Responsibilities:1.
Bioanalytical: articulate strategy and lead the development and
execution of overarching strategies for developing, optimizing, and
qualifying/validating bioanalytical assays for novel, complex
biotherapeutic molecules in support of clinical, CMC, preclinical,
and nonclinical pharmacology and toxicology activities (PK, PD,
Biomarkers, receptor occupancy, ADA, Potency, Metabolites, DDI
studies, etc.). 2. Developability: articulate strategy and lead the
development and execution of biophysical/biochemical
characterization of assets (structural integrity/aggregation state,
purity, stability, binding characteristics, potency, etc.)3. Review
data, analyze, trouble shoot, guide and support on technical
aspects of data interpretation. Ensure that all studies are managed
with scientific integrity and high quality, resulting in timely
delivery of datasets to drive clinical development decisions.4.
Craft immunogenicity risk assessments (including in silico
assessments) 5. Author, review and/or approve technical documents,
protocols, reports, and SOPs6. Evaluate and interpret clinical
trial data, write reports, summary documents, contribute to
clinical study reports and other regulatory documents (e.g., IB,
IND, BLA, etc.), prepare slides and present results to internal and
external stakeholders 7. Guide critical reagent characterization
and life cycle maintenance for assays of decision-enabling studies
in discovery and development 8. Collaborate with QA to ensure
thorough bioanalytical/analytical CRO evaluation, selection, and
management, including vendor audits, personnel training, and
troubleshooting/investigations as needed 9. Lead bioanalytical
budget and resource planning10. Contribute to scientific due
diligence and pipeline development activities, as
assignedRequirements: 1. Ph.D. in Biochemistry, Analytical
Chemistry, Protein Sciences, or other relevant scientific
discipline, and 15+ years' related industry experience in
analytical/bioanalytical development of biologics2. Extensive
scientific and technical experience in the development,
optimization, qualification, and validation of analytical methods,
with demonstrated leadership in areas of PK, PD, ADA and
Neutralizing Antibody methodologies; Knowledge and understanding of
bioanalytical instrumentation (e.g., ELISA, MSD, Western Blot, PCR,
biosensors, Gyros, LC/MS and cell-based assays)3. Significant
experience in developing outsourcing strategies and managing work
effectively via external contract organizations; experience with
bioanalysis, reporting, and interpretation of data from nonclinical
and clinical studies as well as the bioanalytical flow from
discovery to production including technology transfer and oversight
of the Sponsor-CRO relationship.4. Experience with GxP compliance
requirements and FDA regulatory guidelines as applicable in support
of biologics drug development programs. 5. Strong understanding of
the drug development paradigm from research through clinical
development6. Excellent oral and written communication skills, and
an ability to work in a collaborative environment interacting with
different functions to assure streamlined processes with an
emphasis on quality and timeliness7. Experience in writing
technical and management documents, reports and
presentationsPI216045031
Keywords: Larimar Therapeutics, Philadelphia , Vice President, Bioanalytics and Developability, Executive , Thorofare, Pennsylvania
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