Vice President, Bioanalytics and Developability

Company: Larimar Therapeutics
Location: Thorofare
Posted on: May 28, 2023

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