Employer profile
Fulcrum Therapeutics INC
3 open roles indexed with location, benefit, and apply-link signals where available.
Open roles
Showing the most recent indexed roles for this employer.
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Director, Biostatistics
Cambridge, MA
unspecified $225K-$250KDirector, Biostatistics Cambridge, MA Company Overview Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's lead program in clinical development is Pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD). Description Reporting to VP of Biometrics, the Director of biostatistics within the Biometrics Department is a hands-on role and is expected to be the statistics subject matter expert for clinical development programs and studies, including oversight of statistical activities in outsourced clinical trials, while ensuring adherence to all regulatory requirements. This individual is expected to have an in-depth understanding of innovative study designs and statistical methodologies, including estimand strategies, endpoint selection, missing data and multiplicity handling. In addition, this individual will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics department and with clinical development, clinical operations, pharmacovigilance, medical writing, and regulatory affairs. Responsibilities Function as a lead statistician for internal studies. Contribute to enterprise strategy through proactive cross-functional collaborations and influence through decision making. Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address statistical questions from regulatory agencies. Conduct ad-hoc analyses as needed. Provide oversight of biostatistics activities in outsourced clinical trials. Ensure high quality, timely delivery of statistical analysis plans and statistical outputs.
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Director, Pharmaceutical Development
Cambridge, MA
unspecified $240K-$240KDirector, Pharmaceutical Development Cambridge, MA Company Overview Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic disorders and is developing a pipeline of clinical and preclinical assets. Fulcrum's lead clinical asset is pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Pharmaceutical Development function. Description Reporting to the Head of Technical Operations, the Director of Pharmaceutical Development will lead all drug product development activities including technical, managerial, and budgetary aspects. This includes formulation development, manufacture of clinical trial material, process optimization, scale-up, and validation. The successful candidate will lead, plan and manage the technical and business-related activities associated with drug product development and manufacturing at contract development and manufacturing vendors for all dosage form programs. Key Responsibilities Lead all strategic and tactical aspects of drug product development at Fulcrum Design and execute pharmaceutical product development plans for all development programs in accordance with corporate goals Collaborate with colleagues in Drug Substance, Analytical, ClinOps, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time Lead pharmaceutical development for the pociredir program, including CTM for pivotal clinical studies, pre-validation studies, validation
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Director, Analytical Chemistry
Cambridge, MA
unspecified $240K-$240KDirector, Analytical Chemistry Cambridge, MA Company Overview Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic disorders and is developing a pipeline of clinical and preclinical assets. Fulcrum's lead clinical asset is pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Analytical Chemistry function. Description Reporting to the Head of Technical Operations, the Director of Analytical Chemistry is responsible for the design and execution of the control strategies for the manufacture of drug substances and drug products for Fulcrum developmental programs. In this position, the successful candidate will provide technical oversight of all Quality Control (QC) activities at DS and DP contract manufacturers. Additional responsibilities include collaborating with pharmaceutics on pre-formulation activities, collaborating with QA on OOS and OOT investigations and CMC risk management, and helping Reg-CMC author relevant sections of regulatory filings. Key Responsibilities Provide technical leadership to CMOs and CROs for drug substance and drug product process development, including cGMP method development, validation, method transfer, method remediation, data analysis and reporting to ensure compliance with GCP, GLP and cGMP standards Collaborate with colleagues in Drug Substance, Drug Product, QA, and