Fulcrum Therapeutics INC jobs

Director, 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

Director, 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

Director, 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.

Therapeutic Area Manager (TAM), Hematology - Pennsylvania Ecosystem Philadelphia, Pennsylvania, United States of America Embrace the opportunity to become a Therapeutic Area Manager, Hematology, and drive impactful patient outcomes in the Philadelphia ecosystem. Leverage your expertise in oncology and healthcare systems to lead cross-functional teams, optimize product access, and shape clinical strategies. Make a difference in rare disease care with Genentech.

Therapeutic Area Head – Respiratory Remote About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! Role Summary We are seeking a Therapeutic Area (TA) Head, Respiratory - Clinical Development. In this

Drug Safety Manager Viking Therapeutics, Inc. Drug Safety Manager

Clinical Trial Manager Viking Therapeutics, Inc. Clinical Trial Manager

Therapeutic Area Manager (TAM), Breast - Pennsylvania Ecosystem Wilmington, Delaware, United States of America Embrace the opportunity to become a Therapeutic Area Manager, Breast, and drive impactful patient outcomes in the Pennsylvania ecosystem. Leverage your expertise in healthcare sales, account management, and cross-functional collaboration to optimize product access and support innovative treatments. Make a difference in the rare disease community with Genentech.

Senior/Executive Director, Health Economics & Outcomes Research (HEOR) Viking Therapeutics, Inc. Senior/Executive Director, Health Economics & Outcomes Research (HEOR)

Associate Director, Formulation Development Viking Therapeutics, Inc. Associate Director, Formulation Development

Therapeutic Area Lead Vaccines & Infectious Diseases POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center) posted: Posted 2 Days Ago

Director of Process Validation Viking Therapeutics, Inc. Director of Process Validation

Medical Science Liaison Director/Lead Viking Therapeutics, Inc. Medical Science Liaison Director/Lead

Corporate Counsel, Clinical Contracts Remote (US) About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an

Associate Director, Computer Systems Assurance (Quality) Brisbane, CA Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease. Position The Senior Manager / Associate Director, Computer Systems Assurance (CSA) is an important technical and operational leader within the Nurix Quality Systems organization, responsible for owning and advancing Nurix's computer systems assurance program. As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix. Reporting to the Vice President / Senior Director, Quality Systems, this individual will establish and maintain Nurix's risk-based CSA framework aligned with current regulatory expectations, including the FDA's 2022 guidance on computer software assurance, GAMP 5 (2nd edition), and applicable 21 CFR Part 11 and Annex

Therapeutic Area Policy Director South San Francisco, California, United States of America Exciting opportunity for a strategic policy director to shape healthcare policy and optimize patient access across diverse therapeutic areas. Lead cross-functional teams, influence policy at the highest levels, and drive strategic readiness for innovative therapies. Join us to make a significant impact on patient outcomes and healthcare innovation.

Principal Scientist, Peptide Therapeutics South San Francisco, California, United States of America This is a primarily lab-based, technical leadership position within the Peptide Therapeutics department. In this lab-based leadership role, you will combine hands-on synthetic expertise with strategic...

Associate Therapeutic Development Manager HKG - Hong Kong Island - Hong Kong (Lee Garden Two) posted: Posted 16 Days Ago

Executive Director, Therapeutic Strategy Leader, APAC Shanghai, China This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll i...

Associate Director, Clinical Supply Chain Management Remote About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at “good enough”. If this sounds like you, keep reading! Role Summary We are seeking a highly motivated and results-oriented individual to join Apogee Therapeutics

Senior Director, Marketing Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key

Associate Director, Clinical Development Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! The Associate Director, Clinical Development plays a key role in the design and execution of ongoing and new clinical development studies. This position serves as the clinical science representative on one or more U.S. and/or global clinical studies and contributes to the delivery of high‑quality clinical data to support registration and launch. The role partners cross‑functionally with Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Early Development,

Senior Director, Clinical Development Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! The Sr. Director, Clinical Development will play a key role in the design and execution of ongoing and new clinical studies and contribute to the clinical development plan for one or more programs. The position will successfully lead and/or serve as the clinical science representative on one or more clinical studies (US and/or global) to deliver high quality data for registration. The position requires the

Associate Director, Biostatistics Remote Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges. Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Together we are moving psychiatry forward-beyond better, into a boundless future. Join us! As an Associate Director, Biostatistics this person will provide statistical support for pipeline compounds' clinical development, regulatory filing, and commercialization. Reporting to Vice President, Head of Biometrics and Data Science, the successful candidate will serve as the biostatistician for assigned clinical trials to provide statistical leadership from trial design, data analysis, to results interpretation and dissemination. This role will also provide statistical support to regulatory filing