Jobs at Click Therapeutics
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Associate Director, Quality Systems
Company: Corcept Therapeutics
Location: Peninsula
Posted Apr 29, 2024
Corcept is a leading company in the research and development of cortisol modulators, with a focus on treating serious diseases. The company has received FDA approval for its treatment, Korlym, and is continuing to advance the possibilities of cortisol modulation. The company is also seeking a Quality Systems leader to prioritize and manage Quality Assurance and GxP computer systems projects.
Data and Reporting Analyst II - Remote
Company: Prime Therapeutics
Location: Remote
Posted Apr 26, 2024
<p>Our work matters We help people get the medicine they need to feel better and live well We do not lose sight of that It fuels our passion and drives every decision we make <p> <p><strong><b>Job Posting Title<b><strong> <p> <p>Data and Reporting Analyst II Remote <p> <p><b>Job Description Summary<b> <p> <p>Provides data collection data management data analysis and reporting and decision management tool design and development Responsible for interfacing with IT to ensure utilization and effective use of IT sponsored tools Provide basic programming and technical skills to support data management and reporting requirements <p> <p><b>Job Description<b> <p> <ul><li>Works with designated department to assess define and develop report deliverables to meet internal and customer requirements <li> <li>Designs appropriate data repository and reporting tools that will be used to organize analyze and report data <li> <li>Queries databases to extract information needed to develop reports <li> <li>Compiles data and other information from multiple data sources<li> <li>Supports the development of standard reports <li> <li>Interprets analyzes and provides recommendations regarding data accuracy and data collection needs and processes <li> <li>Works with business units to identify opportunities to enhance existing and to develop new data information processes and tools <li> <li>Continuously assesses and improves data collection and reporting processes <li> <li>Coordinates or independently completes special projects <li> <li>Assists staff members with more complex and detailed projects including root cause analyses trended reporting and analyses which support continuous quality improvement leading to actionable information <li> <li>Participates and supports staff training related to data collection and reporting<li> <ul><p><b>Responsibilities<b> <p> <ul><li>Database management<li> <li>Exposure to web based or mobile application development<li> <li>One year of experience using Salesforce preferred<li> <ul><ul><li>Bachelors degree in Business Administration Computer Science IT Mathematics or related field<li> <li>May consider an additional 34 years of relevant experience in lieu of Bachelors degree<li> <li>Requires strong expertise in MS Excel and relational database such as MS Access and other database management MS SQL and reporting tools<li> <li>Ability to use reporting software such as Actuate Cognos Crystal reports SAS or other<li> <li>Ability to query the companys data warehouse andor department systems in response to data requests<li> <li>Strong interpersonal skills<li> <li>Strong written and verbal communication skills<li> <ul><p><b>Work Experience<b> <p> <p>Work Experience Required <p> <p>AnalyticsInformatics <p> <p>Work Experience Preferred <p> <p>Managed Healthcare <p> <p><b>Education<b> <p> <p>Education Required <p> <p>A Combination of Education and Work Experience May Be Considered Bachelors Business Administration Bachelors Computer and Information Science Bachelors Information Technology Bachelors Mathematics <p> <p>Education Preferred <p> <p><b>Certifications<b> <p> <p>Certifications Required <p> <p>Certifications Preferred <p> <p>Potential pay for this position ranges from $6080000 $9728000 based on experience and skills Pay range may vary by 8 depending on applicant location <p> <p>To review our Benefits Incentives and Additional Compensation visit our Benefits Page and click on the Benefits at a glance button for more detail <p> <p>Prime Therapeutics LLC is an Equal Opportunity Employer We encourage diverse candidates to apply and all qualified applicants will receive consideration for employment without regard to race color religion sex including pregnancy sexual orientation gender identity or expression genetic information marital status family status national origin age disability veteran status or any other legally protected class under federal state or local law <p> <p>Positions will be posted for a minimum of five consecutive workdays<p>
Director, Analytical Development
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Apr 29, 2024
<p><b>Company Overview<b><p> <p><br ><p> <p>Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity Our portfolio of precommercial neuroscience assets targets a broad range of central nervous system CNS disorders including schizophrenia epilepsy Parkinsons disease and substance use disorder <p> <p> <p> <p>Headquartered in the Greater Boston area we are bold thinkers deep experts resilient pathfinders and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on peoples lives<p> <p> <p> <p>Cerevel aspires to develop and nurture a culture characterized by trust respect courage curiosity and compassion with a relentless focus on mission and results Our patientcentricity guides our purpose how we treat each other and what we work on every day The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions<p> <p><br ><p> <p><b><u>Role Summary<u><b><p> <p><br ><p> <p>Reporting to Head of Technical Operations CMC the Director Analytical Development is an accomplished technical expert in the diverse techniques instruments and methods applied to analytical characterization across API starting materials through to intermediates on to drug substance and finally drug product for small molecule pharmaceutical development programs This leader will be a driver of technology advancement and execution of analytical development activities occurring in our internal labs and across our partner network of CDMOs and analytical laboratories during the preclinical through clinical development stages The Director will lead and develop a group of highly capable scientists while tackling challenging analytical method development and data interpretation problems in a fastpaced growing company During the clinical development stage they may lead sit on or mentor CMC teams supporting activities across pharmaceutical development They will drive stability strategy through innovative and riskbased stability assessment approaches This functional lead will also provide input and guidance on regulatory strategies and work closely with Quality Assurance Additionally they will partner with finance and program team leaders to develop thoughtful functional area budgets The Director will work closely with their peers in Chemical Process Research Formulation Development Clinical Supplies and Latestage CMC amp Commercial to continue to build Technical Operations at Cerevel and deliver important medicines to patients<p> <p><b>Key Responsibilities<b> <p><ul><li>Work with their team and external partners to develop methods and control strategies for Cerevels portfolio of preclinical and clinical molecules<li> <li>Deliver broad expertise in small molecule analytical development for drug substance and drug product while working closely with chemical process research and formulation development to drive clinical programs<li> <li>Drive and own the specification setting process across drug substance and drug product<li> <li>Propose and support retest dates shelf life and expiry periods<li> <li>Develop mentor and manage staff <li> <li>Lead crossfunctional CMC teams for preproofofconcept programs<li> <li>Drive analytical development activities for drug substance and drug product internally and with partner organizations<li> <li>Manage CDMOs including selection planning and reviewing technical execution ensuring budget and timelines are achieved and data driven decisions for the project are made<li> <li>Develop risk mitigation strategies to ensure issues are managed and program milestones are achieved<li> <li>Partner to define regulatory strategies and author and review CMCrelated sections for regulatory filings<li> <li>Execute within current Good Manufacturing Practice requirements and guidance ensuring Quality is built into every activity<li> <ul><p><b>Required Qualifications<b> <p><ul><li>A PhD and a minimum 10 years of experience of relevant small molecule analytical development or MSBS degrees with additional industry experience directly relevant to small molecule analytical development<li> <li>Demonstrated experience in leading CMC teams<li> <li>Experience in managing CDMOs leading GMP activities and ensuring drug supply for preclinical and clinical studies<li> <li>Demonstrated ability to identify and deliver fitforpurpose and technically sound analytical methods for drug substance and drug product<li> <li>Ability to lead internal and external teams<li> <li>Experience setting specifications for drug substance and drug product<li> <li>Experience setting up drug substance and drug product stability programs and interpreting the data to recommend rest or shelflife periods<li> <li>Demonstrated ability to manage and develop scientific staff <li> <li>Understanding of Regulatory and phaseappropriate Quality requirements governing GMP analysis and control for drug substance and drug product <li> <li>Strong project management interpersonal and communication skills<li> <li>Ability to partner with diverse business functions to enable high quality outcomes<li> <li>Proficient in developing and executing regulatory strategies and authoring and reviewing of the CMC sections of dossiers<li> <li>Experience with solid oral dosage forms both immediate and modified release <li> <ul><p><b>Desired Qualifications<b> <p><ul><li> Desire to work in a fastpace dynamic environment<li> <li>Technical depth across the functions that contribute to pharmaceutical development Process Chemistry Formulation and Analytical Development<li> <li>Excellent communication and presentation skills<li> <li>Team player experienced at developing talent<li> <li>A high degree of autonomy takes accountability for work<li> <li>Experience with identification and process control of potential genotoxic impurities<li> <li>Familiarity with solidstate characterization and control as it relates to drug substances used in solid oral dosage formulations<li> <ul><p><b>Education<b> <p><ul><li>PhD in Chemistry or Chemical Engineering or related disciplines MS degree candidates with substantial direct experience in CMC will be considered<li> <ul><p> <p><p>Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race religion color sex gender identity sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other characteristic protected by applicable law<span> <span><p> <p><p>
Sr. Manager, Supply Chain Planning
Company: Corcept Therapeutics
Location: Peninsula
Posted Apr 29, 2024
Corcept is a leader in cortisol modulator research and development, with over 1,000 proprietary molecules discovered. The company received FDA approval for Korlym® (mifepristone) in 2012, the first treatment for hypercortisolism (Cushing syndrome). Currently, Corcept is conducting more than 30 studies across various disease areas, aiming to revolutionize disease understanding and treatment. The company is seeking a Sr. Manager, Supply Chain Planning to develop end-to-end supply plans for global clinical trials, ensuring continuous drug supply. The role requires experience in global clinical trials, cGMPs, and drug development processes, along with strong communication, organizational, and attention to detail skills. The pay range for this headquarters-based position is $165,000 - $185,000.
Manager, Regulatory Submissions Publisher
Company: Eikon Therapeutics
Location: Other US Location
Posted Apr 25, 2024
Eikon Therapeutics, a biopharmaceutical company, is seeking a Manager, Submissions Publishing. The role involves overseeing regulatory submissions, managing a team, and collaborating with cross-functional teams. The ideal candidate should have a post-graduate degree or bachelor's with relevant experience, strong understanding of global regulatory requirements, and proficiency in electronic submissions tools. Eikon offers competitive compensation, benefits, and a safe workplace with a vaccination requirement.
Senior Director, Clinical Pharmacology
Company: Maze Therapeutics
Location: Peninsula
Posted Apr 26, 2024
Maze Therapeutics is seeking a Senior Director, Clinical Pharmacology to join their Clinical Science team. The role involves translating genetic insights into innovative treatments for patients, particularly for chronic kidney disease. The successful candidate will lead the Clinical Pharmacology strategy, collaborate with cross-functional teams, and contribute to the design, conduct, and interpretation of key clinical studies. They will also be responsible for compliant data analyses, co-authoring clinical-regulatory documents, and investigating new methods in the field. Maze Therapeutics offers a competitive salary, robust benefits, and a culture that values vision, initiative, and patient-centricity.
Manager, Data Management Programming
Company: Eikon Therapeutics
Location: Other US Location
Posted Apr 25, 2024
Eikon Therapeutics is hiring a Manager, Data Management Programmer to build, maintain, and deploy study databases, reports/dashboard, and provide EDC technical expertise. The role requires at least 8 years of global clinical trial expertise with a focus on EDC database development, 2 years of reports/dashboard development experience, and strong knowledge of industry leading EDC tools and GCP/ICH guidelines. The company offers competitive compensation, benefits, and a safe workplace with a requirement for full vaccination against COVID-19.
Senior LIMS Engineer
Company: Eikon Therapeutics
Location: Other US Location
Posted Apr 25, 2024
Eikon Therapeutics is hiring a Senior Engineer, Lab Information Management Systems (LIMS) to design and implement LIMS and integrated data management solutions. The ideal candidate should have a Ph.D. or MS with 3 years of relevant experience, or a BS with 5 years of experience in computer science, life science, engineering, or a related field. They should have experience with ELN, LIMS, scientific data management, compound registration, sample inventory, instrument data capture, assay results, and electronic laboratory notebooks, specifically on CDD Vault and Dotmatics. The candidate will work on system design, implementation, and change management for R&D informatics solutions, including LIMS, Inventory Management, and ELN. They will also contribute to the design, development, test, and implementation of LIMS solutions, and collaborate with a cross-functional team to develop an end-to-end digital architecture roadmap.
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Company: ReCode Therapeutics
Location: Peninsula
Posted Apr 26, 2024
<div> <p><strong>Who We Are<strong><p> <p>ReCode Therapeutics is a clinicalstage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics ReCodes proprietary Selective Organ Targeting SORT lipid nanoparticle LNP platform enables highly precise and targeted delivery of genetic medicines directly to the organs tissues and cells implicated in disease enabling improved efficacy and potency ReCodes lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene and RCT2100 for the treatment of the 1013 of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators RCT1100 and RCT2100 are inhaled diseasemodifying mRNAbased therapies formulated using the SORT LNP delivery platform ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases including musculoskeletal central nervous system liver and infectious disease indications<p> <div> <p><strong>Dont see an opening that aligns with your expertise and interest We encourage you to submit your resume and let us know what areas youre interested in Well keep you informed of opportunities that arise in the future<strong><p> <div> <p><strong>Benefits Offered for FullTime Employees <strong><p> <ul><li>No premium cost for employees 100 subsidized by ReCode for fulltime employees<li> <li>Company 401k contribution<li> <li>15 days of company paid holidays including a holiday shutdown usually the last week of the year<li> <li>Mental health support for employees amp their families<li> <li>FSA available including a lifestyle spending account subsidized by company<li> <li>Employee discounts at hotspots<li> <ul><p>ReCode Therapeutics wwwrecodetxcom offers a competitive compensationbenefits package with a friendly collaborative culture that values employee engagement and ongoing career development<p> <p>ReCode Therapeutics is an Equal Opportunity Employer<p> <div>
Senior Clinical Trial Manager
Company: Maze Therapeutics
Location: Peninsula
Posted Apr 26, 2024
Maze Therapeutics is seeking an experienced Senior Clinical Trial Manager to join their Clinical Operations Team. The role involves strategically planning and managing early development clinical trials in kidney disease, ensuring high-quality data and timely conduct per GCP standards. The successful candidate will collaborate with internal teams, manage external vendors, and ensure adherence to study protocols and ICH GCP guidelines. The position requires a degree in a scientific discipline, at least 6 years of clinical research experience, and proficiency in FDA regulatory requirements and ICH GCP guidelines. Maze Therapeutics is a biopharmaceutical company focused on genetically informed therapies for common diseases, with a pipeline of novel precision medicines. The company is based in South San Francisco and offers a competitive salary and benefits package.
Sr. Research Associate 1, Research Biology
Company: Eikon Therapeutics
Location: Other US Location
Posted Apr 25, 2024
Eikon Therapeutics is hiring a Senior Research Associate 1 to join their dynamic research team. The ideal candidate should have extensive hands-on experience in various laboratory techniques, proficiency in data analysis software, and excellent communication skills. The role involves designing and executing complex experiments, collaborating with cross-functional teams, and staying updated with the latest scientific breakthroughs. The company offers competitive compensation, benefits, and a safe work environment.
Senior Scientist, Analytical Development
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Apr 29, 2024
<p><b>Company Overview<b><p> <p><br ><p> <p>Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity Our portfolio of precommercial neuroscience assets targets a broad range of central nervous system CNS disorders including schizophrenia epilepsy Parkinsons disease and substance use disorder <p> <p> <p> <p>Headquartered in the Greater Boston area we are bold thinkers deep experts resilient pathfinders and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on peoples lives<p> <p> <p> <p>Cerevel aspires to develop and nurture a culture characterized by trust respect courage curiosity and compassion with a relentless focus on mission and results Our patientcentricity guides our purpose how we treat each other and what we work on every day The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions<p> <p><br ><p> <p><b><u>Role Summary<u><b><p> <p><br ><p> <p><span>The Senior Scientist will have significant experience in analytical method development analytical characterization and control with an emphasis on late clinicalstage to commercial development The Senior Scientist reports to the Analytical Lead within Latephase and Commercial CMC and they will provide analytical expertise in drug substance and drug product analytical development for small molecule postproof of concept through longterm commercial development and manufacturing They will work closely with colleagues across pharmaceutical development to best leverage Cerevels internal development capabilities including process chemistry analytical and formulation development labs instruments and equipment Additionally they will identify and manage external partners for latephase method development as well as latephase through longterm commercial analytical testing and characterization across Cerevels portfolio of latestage programs The Senior Scientist will grow as a subject matter expert both within and outside the department and will help drive of pharmaceutical development as part of this growing dynamic team<span><p> <p><b>Key Responsibilities<b> <p><ul><li>Guide and drive analytical method development implementation as well as drug substance and drug product characterization and control for Cerevels latestage to commercial programs<li> <li>Provide technical support and daytoday management of outsourced drug substance and drug product method development activities with CMO partners<li> <li>Manage analytical testing activities including in process drug substance and drug product release testing through review of analytical data<li> <li>Present technical data to cross functional teams and senior management as an expert in analytical driver for Cerevels latestage development programs<li> <li>Design support and analyze method transfer and validation activities across a portfolio of small molecule solid oral dosage projects<li> <li>Author and review drug product and drug substance analytical sections for regulatory submissions<li> <li>Support any quality investigations or events and resolve them in a timely manner<li> <li>Train and recruit latephase and commercial CMC staff<li> <li>Identify and advocate new and emerging technologies in analytical and physical characterization analysis<li> <li>Drive the specification setting process from API starting materials to drug product for latestage and commercial projects<li> <li>Partner with Chemical Process Development and Formulation Development staff to assess and support drug substance and drug product characterization and retestshelflife setting<li> <ul><p><b>Required Qualifications<b> <p><ul><li>Demonstrated expertise in late phase and commercial analytical development method transfer and stability program design and execution<li> <li>Experience with managing external testing laboratories during late clinicalstage pharmaceutical development<li> <li>Subject matter proficiency in the analytical development of oral formulations with experience in discriminating dissolution test method development HPLC GC titrations spectroscopic methods and physical characterization techniques such as Xray powder diffraction DSC and TGA<li> <li>Knowledge and the ability to interpret and draw conclusions from data from analytical techniques employed across drug substance and drug product development<li> <li>Ability to troubleshoot analytical method and testing issues determine causes and possible solutions<li> <li>Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment<li> <ul><p><b>Education<b> <p><ul><li>PhD or equivalent degree in relevant discipline and 2+ years relevant work experience<li> <li>BS MS in relevant discipline and 8+ years relevant work experience<li> <ul><p> <p><p>Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race religion color sex gender identity sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other characteristic protected by applicable law<span> <span><p> <p><p>