Jobs at Click Therapeutics
249,921 open positions
Manager, Translational Biomarker Operations
Company: Dyne Therapeutics
Location: Waltham
Posted Feb 29, 2024
Dyne Therapeutics is seeking a Manager, Translational Biomarker Operations to oversee clinical trial samples, manage CROs, and collaborate with cross-functional teams. The role involves sample management, contracting, invoice management, and meeting management. The ideal candidate should have a life sciences degree, 5+ years of relevant experience, and expertise in clinical sample collection, processing, and storage. Familiarity with GxP, ICH/GCP, CAP/CLIA regulations is required. The position is based in Waltham, MA and is not remote.
Associate Director, OT Integration Solutions
Company: Spark Therapeutics, Inc.
Location: Philadelphia, PA
Posted Mar 01, 2024
Spark Therapeutics is seeking an Associate Director, OT Integration Solutions to lead the delivery of operational technology data integration platforms. The role involves managing matrix teams, collaborating with key business stakeholders, and developing the overall digital strategy for the Patient Supply Organization. The ideal candidate should have a BS/MS/PhD in Life Science/Engineering, 10+ years of experience in the Biotechnology or Pharmaceutical industry, and expertise in process automation, data management, and industrial data integration within a gene therapy manufacturing environment.
Associate Director, Analytical Development/Quality Control
Company: Dyne Therapeutics
Location: Waltham
Posted Feb 29, 2024
Dyne Therapeutics is seeking an Associate Director for analytical development, technology transfer, and validation of CMC activities related to external QC testing/release and stability of antibody drug conjugates and intermediates. The role involves managing analytical development and QC activities in Phase 1 through BLA and commercial production, coordinating with CDMOs, CTLs, and other external suppliers. The candidate must have a minimum of 8 years in Analytical Development and/or Quality Control, a degree in biology, biochemistry, chemistry, or a related field, and strong knowledge of analytical techniques and cGMP/ICH/FDA/EU regulations. The role requires excellent interpersonal, organizational, negotiation, and communication skills, and the ability to travel up to 10%. Dyne Therapeutics is an equal opportunity employer.
Staff Accountant
Company: Tango Therapeutics
Location: Boston, MA
Posted Mar 01, 2024
<p><strong>Company Overview<strong><p> <p>Tango Therapeutics is a biotechnology <span datamarkjs=true dataogac= dataogab= dataogsc= dataogsb=>company<span> dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer<p> <p>Using an approach that starts and ends with patients Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer<p> <p>This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing<p> <p dataeventadded=1>The Tango labs and offices are located at <span datamarkjs=true>201 Brookline Avenue in<span> the Fenway area of Boston Massachusetts<p> <p><br ><p><p><strong>Summary<strong><p> <p>Reporting to the Manager of Accounting this individual will be a critical and core member of the growing accounting and finance team and will partner with the Senior Accountant Controller and VP of Finance to help scale the finance function as the company continues to grow<p> <p><br ><p><p><strong>Your Role <strong><p> <ul><li>Prepare monthly account reconciliations<li> <li>Assists with the preparation of period end financial statements<li> <li>Prepare and record journal entries to the general ledger<li> <li>Assist with the period close process including performance and documentation of internal controls<li> <li>Continuously monitor the AP inbox and support the weekly payment run<li> <li>Support various system maintenance and potential future system implementations<li> <li>Help to prepare documentation for external auditors requests<li> <li>Assist with compiling tax workpaper support for tax provisions and annual tax returns<li> <li>Support the Finance team with various adhoc requests and projects as needed<li> <li>Maintain effective relationships with other departments to ensure effective and efficient crossfunctional collaboration<li> <li>Specific areas of responsibilities may include but are not limited to cash prepaid expenses fixed assets accounts payable accrued expenses and payroll<li> <li>Maintains knowledge of acceptable accounting practices and procedures<li> <ul><p><strong>What You Bring <strong><p> <ul><li>A minimum of a bachelors degree in accounting or related field is required<li> <li>Minimum of 1 year of experience in accountingfinance is required<li> <li>Excellent verbal and written communication skills<li> <li>Excellent organizational skills and attention to detail<li> <li>Understanding of and the ability to adhere to generally accepted accounting principles<li> <li>Public accounting experience is a plus<li> <li>Proficiency in Microsoft Office specifically Excel is required<li> <li>Experience with NetSuite is preferred<li> <li>Previous life sciences industry experience is preferred but not required<li> <li>Ability to work independently and within a team environment is important<li> <ul><p><br ><br ><p><p><em>We are an equal opportunity employer and value diversity at our company We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status<em><p> <p><br ><br ><p>
Senior Project Manager - IT
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Mar 01, 2024
4D Molecular Therapeutics, Inc. (4DMT) is a clinical-stage biotherapeutics company that innovates in genetic medicines. They use their platform, Therapeutic Vector Evolution (TVE), to develop targeted genetic medicines for various diseases. 4DMT has a robust technology and IP foundation, with five product candidates in clinical trials and two in preclinical studies. They have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas. The company is fully integrated, with internal manufacturing, and has a strong track record in project management. They are seeking an IT Project Manager to ensure projects adhere to budget, schedule, and scope, and to manage project teams effectively.
Scientist II/Senior Scientist, Analytical Operations (AMD)
Company: Capstan Therapeutics
Location: San Diego, CA
Posted Mar 02, 2024
Capstan Therapeutics is seeking a Scientist II/Senior Scientist in Analytical Operations to develop analytical methods for characterizing nucleic acid payloads and bioactivity of mRNA-based lipid nanoparticle drug products. The role involves designing and executing routine and non-routine analytical analyses, ensuring adherence to industry standards, and mentoring team members. The company offers a competitive salary, performance bonus, equity, benefits, and a fast-paced, entrepreneurial work environment.
Lead Network Architect (Manager Level)
Company: Spark Therapeutics, Inc.
Location: Philadelphia, PA
Posted Mar 02, 2024
Spark Therapeutics is seeking a Lead Network Architect to design, develop, and oversee network architectures. The role involves partnering with the Enterprise Architecture team, providing technical leadership, and ensuring high availability of network systems. Responsibilities include developing processes, procedures, and standards for network operations, designing and maintaining network management architecture, and overseeing the implementation of LANs, WANs, and wireless networks. The ideal candidate should have a Bachelor's degree in a computer science or technical discipline, minimum 7 years of advanced experience in a complex network environment, and extensive experience with Cisco and Fortinet platforms.
Senior Manager, eTMF Management
Company: Tango Therapeutics
Location: Boston, MA
Posted Mar 01, 2024
<p><strong>Company Overview<strong><p> <p>Tango Therapeutics is a biotechnology <span datamarkjs=true dataogac= dataogab= dataogsc= dataogsb=>company<span> dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer<p> <p>Using an approach that starts and ends with patients Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer<p> <p>This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing<p> <p dataeventadded=1>The Tango labs and offices are located at <span datamarkjs=true>201 Brookline Avenue in<span> the Fenway area of Boston Massachusetts<p> <p><br ><p><p><strong>Summary<strong><p> <p>Tango has an exciting new opportunity to join the team as our first Trial Master File Manager to support strategy governance training and maintain documentation related to TMF activities across the portfolio You will report to the Director of Clinical Compliance You will manage filing and maintenance activities for clinical trials during the study startup maintenance and closeout periods You will be detail oriented with a flexible and solutionoriented outlook and the ability to support clinical team members within Tango and across our CRO partners<p> <p><br ><strong>Your role<strong><p> <ul><li>You will maintain effective communication with project teams CRO staff and vendors throughout study startup maintenance and closeout<li> <li>Support study document filing into the trial TMF<li> <li>Review and ensure compliance and oversight of TMF plans<li> <li>Perform routine quality checks of documents uploaded into the TMF across trials and ensure findings are documented and resolved in a timely manner<li> <li>Respond to inquiries regarding TMF management and contents<li> <li>Attend departmental and studyspecific meetings and discussions as required<li> <li>Run routine TMF reports and monitor for completeness and trends<li> <li>May provide TMF training to new team members<li> <li>Perform general administrative tasks<li> <li>Complete other study documentrelated tasks as required by the study teams<li> <li>Additional duties and responsibilities as required<li> <ul><p><strong> <strong><p> <p><strong>What you bring<strong><p> <ul><li>Life sciences degree or certification in a related allied health field<li> <li>35 years experience with clinical trials eg study coordinator regulatory operations and electronic TMF document management experience<li> <li>Clear and timely communication skills<li> <li>Understanding of GCP and regulatory requirements as well as a working knowledge of clinical research documents their contents and purpose<li> <li>Demonstrated proficiency with MS Office skills such as Outlook Word Excel PowerPoint and SharePoint<li> <ul><p><br ><p><p><strong> <strong><p> <p><br ><br ><p><p><em>We are an equal opportunity employer and value diversity at our company We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status<em><p> <p><br ><br ><p>
Senior Manager, Computerized Systems Quality Assurance
Company: Kyverna Therapeutics
Location: Other US Location
Posted Mar 02, 2024
<p><span>Kyverna Therapeutics is a clinicalstage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases Be at the forefront of cell therapy innovation by joining scientists industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated<span><p> <p><br ><p> <p>Kyverna is recruiting a highly motivated Senior Manager of Computer Software Assurance Computer System Validation in its Quality organization to help advance its mission to free patients from the siege of autoimmune disease The ideal candidate will build and lead a Software Quality Assurance CSA program focusing on GAMP 5 and Health Authority Part 11 and Annex 11 compliance for systems wholly managed by Kyverna as well as assessing and communicating risks associated with the the compliance of systems managed by Kyverna contract service providers CSP and partners Adherence to phase appropriate regulatory requirements enhancing quality compliance and maintaining the highest standards of quality in CSA for technical clinical and regulatory operations is the mission of this role<p> <p><br ><p> <p>The Senior Manager will be responsible for creating and executing a CSA program for Kyverna including quality management elements SOPs and policies lifecycle management validation change management risk assessment and assessing the compliance of computerized systems utilized by Kyverna CSPs in support of clinical operations manufacturing and regulatory systems The role will report to the Head of GxP Quality<p> <p><b>Responsibilities<b> <p><ul><li>In collaboration with Quality Technical Operations Regulatory Affairs Clinical Operations and Finance support automation Veeva SAP logistics document management Veeva Vault Veeva RIMS and learning management ComplianceWire strategies for Kyvernas operations including qualification validation and lifecycle management support<li> <li>Develop and maintain Kyvernas CSA program including establishment of protocols lifecycle management and CSP audit support<li> <li>Manage ValidationQualification of systems as needed to support multiphase clinical trials<li> <li>Provide subject matter expertise in the investigation of computerized system quality events<li> <li>Support operations to develop and monitor key performance indicators and risk management to ensure effective and efficient processes compliant system utilization and oversight of Kyvernas systems<li> <li>Ensure computerized system issues are identified and managed through to resolution in a timely manner and support the administration of these systems<li> <li>Work with functional leadership to design implement and maintain phase appropriate levels of automation in support of Kyvernas programs<li> <li>Support business development due diligence projects as needed to support analysis and assessment of internalexternal laboratory capabilities<li> <li>Other duties as assigned<li> <ul><p><b>Requirements<b> <p><ul><li>Degree bachelors or higher or equivalent experience in life sciences or computer sciences or related field<li> <li>8+ years of pharmaceutical manufacturing andor Quality Assurance experience with at least 2 years experience with computer systems validation<li> <li>Experience implementing systems compliant with GAMP 5 Annex 11 or Part 11<li> <li>Demonstrated ability to manage contract resources supporting CSV including authoring of validation master plans and protocols training against protocols and writing summary reports<li> <li>Deep knowledge and experience with one or more of the leading lifecycle quality management regulatory information or ERP systems is required<li> <li>Ability to think critically and demonstrated troubleshooting problemsolving and risk assessment skills<li> <li>Strategic thinking and high emotional intelligence<li> <li>Excellent interpersonal verbal and written communication skills<li> <li>Ability to function efficiently and independently in a changing environment<li> <li>Manage and advance multiple projects simultaneously and dynamically reprioritize as needed<li> <li>Demonstrated capacity to think creatively when addressing complex situations<li> <li>Ability to communicate effectively with Kyverna Leadership clinical biomarker biostatistical and preclinical scientists and with external business partners and Regulatory Authorities<li> <ul><p> <p><p><span>The salary range for this position is from $140000 $155000 USD annually This salary range is an estimate of what we reasonably expect to pay for this posted position and the actual salary may vary based on various factors including without limitation individual education experience tenure skills and abilities as well as internal equity and alignment with market data This position is also eligible for bonus benefits and participation in Companys stock option plan<span><p> <p><br ><p> <p><br ><p> <p><span>Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race religion color sex gender identify sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other legally protected status EOEAAVets<span><p> <p><p>
Manager/Senior Manager, Compliance
Company: Axsome Therapeutics, Inc.
Location: Remote
Posted Feb 28, 2024
Axsome Therapeutics is a biopharmaceutical company seeking a Manager/Senior Manager, Compliance. The role involves executing elements of the company's healthcare compliance program, auditing and monitoring business activities, and working closely with the Director, Compliance.
VP of Portfolio Management
Company: Dragonfly Therapeutics
Location: Waltham
Posted Feb 28, 2024
Dragonfly Therapeutics is seeking a VP of Portfolio Management with a strong scientific background in Oncology, Immunology, or Immuno-oncology. The role involves overseeing programs and alliances, collaborating with stakeholders, leading cross-functional teams, and communicating effectively across all levels of the organization. The ideal candidate should have a life sciences degree, advanced degree preferred, and at least twelve years of industry experience, including five years in a project leadership role. Proficiency in MS Office and timeline management tools is required. Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing therapies using its novel multispecific antibody technology.
Principal Scientist, Biomarkers & Immunology
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Mar 02, 2024
4D Molecular Therapeutics, Inc. (4DMT) is a clinical-stage biotherapeutics company that innovates in genetic medicines. They have a robust technology platform, Therapeutic Vector Evolution (TVE), which combines directed evolution with synthetic AAV capsid-derived sequences to invent evolved vectors for their products. 4DMT has a deep portfolio of AVV-based gene therapy product candidates, with five in clinical trials and two in preclinical studies. The company is seeking a Principal Scientist for the Biomarkers & Immunology group, responsible for immunogenicity assessments, biomarker measurements, and molecular assays during AAV therapeutics development. The role involves leading bioanalytical subteams, assessing CROs, and contributing to the design and implementation of non-clinical and clinical studies.