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Director, GMP Quality Assurance
Company: Entrada Therapeutics
Location: Boston, MA
Posted Aug 07, 2023
Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.Third Party Staffing AgenciesEntrada does not accept unsolicited resumes from any source other than directly from candidates. The successful candidate will have a strong understanding of GMP Quality for raw materials, drug substance, drug product, and label and packaging, including QC testing, stability, and distribution. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. The position will focus initially on GMP Quality build-out to strengthen Clinical-phase Quality Systems, ensuring that systems and processes developed will accommodate global Quality System requirements. The position is based in Boston, MA and reports directly to the Sr. Director, Quality Assurance.ResponsibilitiesLead QA oversight of GMP activities at Entrada and its contract development and manufacturing organizations (CDMOs), testing laboratories, and logistics vendors.Develop and implement risk-based Quality strategies for investigational and materials including establishment and maintenance of phase appropriate quality systems; proactively identify and mitigate quality risks.Be responsible for quality-related activities and requirements to enable release of Raw Materials, Drug Substance, Drug Product, and Finished Goods.Oversee GMP/GDP vendor management, assuring that vendors are operating in compliance with the applicable quality program and regulations/ guidelines and are prepared for Regulatory inspections.Lead development, implementation, and maintenance of GMP Quality Systems and SOPs related to GMP/GDP activities.Lead Quality investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with investigations, deviations, product complaints and recalls.Provide quality input and oversight for process validation, process performance qualification, and continuous process verification.Oversee clinical distribution, logistics, and launch activities.Collaborate with CMC to establish metrics and report the state of GMP Quality and compliance of GMP vendors to senior management.Ensure CMC and GMP/GDP vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standards.Stay abreast of industry developments – forthcoming regulations, guidance, best practices, and etc., training and mentoring staff on global GMP regulations and guidance.Ensure external inspection readiness and pre-approval Regulatory inspection readiness to prepare for audits by external parties and global Regulatory Health Authorities.The NecessitiesAt Entrada, our passion for science, our devotion to patients and our values drive our behavior:Humanity - We genuinely care about patients and about one another.Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.Creativity - We are creative problem solvers.Collaboration - We are more than the sum of our parts.Curiosity - We have a growth mindset and push conventional thought and theory.To thrive on our team, you will need to come with:Minimum BS degree in Science or Engineering, advanced degree a plus, and 10 years of applicable pharmaceutical drug development experience with at least 8 years of Quality Assurance experience, including Supply Chain QA. Useful background could include experience with oligonucleotides, large molecules, parenteral aseptic fills and filing of an IND/NDA.Demonstrated success leading and motivating cross-functional teams and managing direct reports.Track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently.Strong working knowledge of global GXP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.Excellent leadership skills including an effective written and oral communicator, including experience preparing and making presentations to executive level management and interacting effectively with internal and external organizations, collaborators, and customers.Willingness to travel up to approximately 25%.The PerksBy becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. The Director, GMP Quality Assurance is accountable for ensuring that vendors are compliant with global regulations, prepared for potential Sponsor and Regulatory Inspections and that the appropriate processes, systems and activities are in place and performed to protect patient safety, product quality, and data integrity.This is an exciting, interdisciplinary role for a highly qualified and motivated individual. The scope of this leadership role includes oversight of GMP activities at Entrada and its contract development and manufacturing organizations (CMOs), suppliers, testing laboratories, and logistics vendors. This expertise, along with drug development background and the organizational and interpersonal skills required to build and foster strong relationships with collaborators, will be needed for success. You excel at building relationships and trust with your key stakeholders.The OpportunityThe Director of GMP Quality Assurance will be responsible for strategic and operational management of manufacturing, testing laboratory, and release and distribution-related Quality activities. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. You are able to lead teams and develop strategies while not being afraid to roll up your sleeves and perform Batch Release, review and approve Analytical Methods, manage CMO quality documentation and write Quality Plans as needed.You are an excellent team player and relationship builder.
Sr. GxP Digital Systems Specialist
Company: Spark Therapeutics, Inc.
Location: Philadelphia, PA
Posted Aug 08, 2023
Additionally, support Data Integrity efforts to ensure compliance across digital systems. Internal and External Contacts Accountable to Research & Technology areas supported Internal Contacts - Support of Scientific business areas throughout R&T, Corporate IT, CSV, CQV, IT, QA, and GxP Digital Systems External Contacts - Vendor ecosystem role may require some travel Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. 25 Identify opportunities to improve existing processes, equipment, systems, and infrastructure by both leveraging and setting industry best practices. Proven track record organizing and delivering applications from concept to go-live in a lab environment Demonstrated technical project management experience to develop project goals, budgets, deliverables, and timelines. Collaborate with Corporate IT to ensure digital systems leveraged by Research and Technology are ideated, evaluated & selected, approved, constructed, delivered, and supported in accordance with Spark principles, policies, and standards. Key Skills, Abilities, and Competencies Experience with support and administration of laboratory systems Familiarity with lab master data management (MDM), including MDM for digital systems Strong understanding of lab data workflows and optimization techniques Ability to effectively communicate to scientific end users and provide training on lab software packages Complexity and Problem Solving Leads internal teams in solving of complex problems. Minimum 5 years of experience in the Biotechnology or Pharmaceutical industry working with and supporting Lab applications Knowledge of GxP (GLP/GMP) requirements surrounding deployment of Digital Systems and Lab Operations Hands-on development experience with lab system customizations/configurations Experience with SDLC Strong GDP skills Preferred: Preferred experience with SaaS deployments with a focus on configuration, API development and lab system integrations. The incumbent is also expected to ensure computerized system compliance with 21 CFR Part 11. 20 Ensure plans are created and updated in a timely manner, communicated to relevant stakeholders, assess risks, and manage deliverables. Support any appropriate investigations and change management to support the system.
Office Coordinator
Company: Shape Therapeutics
Location: Seattle, WA
Posted Aug 05, 2023
Employees are eligible to enroll in our Company’s voluntary 401k plan, voluntary Life/AD&D and Voluntary FSA’s.The hourly pay range for this role is $22.00 - $30.00. We are proud to offer a competitive paid parental leave benefit, an annual employee stipend for employees to use however they choose, a Flex Paid Time Off program (allowing flexible PTO for vacation, sick leave, and other purposes) and Company paid Long Term Disability. not only through our science, but also through our commitment to foster an inclusive environment that supports diverse perspectives and experiences. Additional compensation may include annual target bonus and/or sign-on bonus, equity grant and relocation bonus.We aspire to Shape Life! This position requires excellent communication skills, a proactive mindset, and the ability to multitask effectively.What you’ll doGreet and assist visitors and employees in a professional and friendly manner at ShapeTX headquarters in Seattle, WA.Manage incoming and outgoing mail and packages.Maintain office supplies inventory and place orders as needed.Assist with the maintenance and organization of office facilities and equipment.Collaborate with various departments to ensure smooth interdepartmental communication and coordination.Assist in organizing company events, meetings, and conferences..Oversee ShapeTX‘s Google phone messages and respond and/or distribute as needed.Assist with managing ShapeTX‘s access card system.Support the business with additional projects, as needed.What you bringExceptional organizational and time management skills, with a proven ability to prioritize tasks, meet deadlines, and learn new systems and processes.Strong attention to detail and accuracy in all work.Excellent written and verbal communication skills.Evolved people-skills to enable an excellent customer experience to internal and external partners.Comfortable being adaptable in a changing high-paced environment requiring flexibility.Dependable and highly professional, with a demonstrated strong work ethic.Strong problem-solving skills and the ability to work independently and as part of a team.Demonstrated ability to multitask and adapt to changing priorities in a fast-paced environment.Possess good judgment and excellent follow-up skills.Must be digitally savvy and able to learn new platforms.Previous experience in event planning and coordination is a plus.Compensation & BenefitsShapeTX offers a robust benefits package, including but not limited to: Medical, Dental and Vision coverage for employees and their eligible dependents. You can find us at shapetx.com and on LinkedIn and Twitter.At ShapeTX, we are a dynamic team of professionals who are dedicated and passionate about making cures a reality. Through diversity of thought, scientific knowledge, professional rigor and focus we are merging cutting-edge science with extensive drug development expertise to unlock cures to many debilitating diseases.Shape Therapeutics is headquartered in Seattle, Washington with a satellite site in Boston, Massachusetts.Position OverviewShapeTX is seeking an experienced, highly organized, and detail-oriented individual for the role of Office Coordinator. The hired applicant's placement within the range is based on qualifications and professional experience. The ShapeTX platform enables pharma innovators to design treatments across a wide range of diseases, including rare genetic disorders as well as debilitating conditions, such as Alzheimer’s, Parkinson’s, and many more. In this position, you will be responsible for helping ensure the smooth and efficient operation of our office environment.
Senior Manager, Supply Planning
Company: Allogene Therapeutics
Location: East Bay
Posted Aug 05, 2023
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.As an equal opportunity employer, Allogene is committed to a diverse workforce. Master’s degree in business management (MBA) preferredMinimum of 6 years of experience in an Operations role in the Life Sciences and/or Medical Devices industryStrong background in biotechnology supply chain planning and demand managementAbility to communicate and collaborate with different stakeholders, including with Manufacturing, Quality, Regulatory, Clinical Operations, Commercial, Process Development, Finance and othersExcellent presentation skills, including communication and influence with all levels of staff, including executivesStrong quantitative and qualitative skills, with a high aptitude for problem-solving in a GMP environmentAbility to objectively evaluate options/trade-offs and develop executive management-level recommendationsFluency in an ERP system for demand/supply planning is preferred[BF1] Proven leadership skills and organizational management experienceExperience developing and mentoring staff preferableAbility to effectively work in a fast-paced, biotech environment, while dealing with ambiguityExcellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelinesAbility to work independently and as part of a teamCandidates must be authorized to work in the U.S.We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The position will report to the Associate Director, Supply Planning and will be located at Newark, CA or South San Francisco, CA. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careersLI-AW1 We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.Responsibilities include, but are not limited to:Develop detailed production plans for all applicable cell therapy programsResponsible for meeting supply requirements while balancing resource capacity utilization, clinical requirements, and inventory levels Lead planning and allocation of cell therapy starting materialsManage Sales and Operations Planning process to ensure alignment of clinical and commercial demand and manufacturing capacity Represent Supply Chain for program specific CMC meetingsContinually define and review planning and inventory strategy to support applicable sitesCoordinate with External Manufacturing to ensure supply of make-to-order starting materialsProactively identify and mitigate any potential supply interruptionsDrive CAPAs, change controls, SCARs as neededLead Supply Chain scenario assessments as neededPotential to build and manage team as needed to accommodate company growthOther duties as assigned Position Requirements & Experience:Bachelor’s required, degree in science/engineering is a plus. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.About the role:Allogene Therapeutics is seeking a highly motivated Senior Manager, Supply Planning to lead planning for cell therapy starting material production. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients.
Director, Quality Assurance Commercial Operations
Company: CymaBay Therapeutics
Location: North Jersey
Posted Aug 08, 2023
Identify, communicate, and escalate quality and compliance risks. deviations, customer complaints), and CAPAs in response to supplier, manufacturing and/or laboratory discrepancies. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. CymaBay is a multi-state employer, and this salary range may not reflect the position outside of the Bay Area or in other states. Assure functional metrics are reported to management.Ensure alignment with Quality Management TeamPerform other duties, as assignedMINIMUM QUALIFICATIONSMinimum 10 years' related pharmaceutical manufacturing experience and five (5) or more years’ experience in a Quality management position in a GMP/pharmaceutical environment or equivalent Thorough understanding of GMP regulations and industry practicesStrong working knowledge of pharmaceutical quality systems (deviations, CAPA, GMP change controls)Proven managerial skill and ability to work in a team setting within the organization and with external CDMO/CMOs.Demonstrated success in coaching, mentoring and training across functions.Excellent written, oral and interpersonal communication skills.Ability to think and act strategically.Self-directed, juggle multiple tasks and strong ability to work effectively with cross-functional teams.Experience leading deviation and non-conforming material investigations.Proven technical writing/editing skills and problem-solving ability.Strong attention to detail, excellent organization skills and cultural fit.Proficiency in Microsoft Office applicationsAbility to operate in a fast-paced, multi-disciplinary virtual environment.Ability to travel 15-20% domesticallyThe anticipated salary range for the position based in Newark, California is $200,000 - $230,000. Ensure effective and reliable lot disposition and release activities for drug products within established timeframes to meet customer commitments.Track and trend quality metrics, analyze trends and identify and assure implementation of improvement initiatives. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency.Interact and develop relationships with CDMO/CMOs and continuously improve all aspects of quality to achieve and sustain conformance to internal and external requirements.Ensure Independent QA review and approval of master and executed batch records, CoAs, and analytical test results. Participate in the negotiation of Quality Agreements.Assure effective systems, processes, validations, and controls are established and maintained to support commercial operations. NDA). Oversee implementation of ongoing verification activities to assure products are continuously manufactured right the first time.Assure timely issuance, resolution and closure of investigations (e.g.
Senior Financial Analyst (NetSuite Experience Required)
Company: Scorpion Therapeutics
Location: Boston, MA
Posted Aug 07, 2023
We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. In addition, the individual will work with the EVP of Finance on Scorpion’s financial forecasting model and assist with maintaining and updating the company’s forecasts each quarter.Principal Responsibilities:Provide financial analysis and reporting on research and development programs.Work with the Project Teams to understand program assumptions and collect financial forecasts.Responsible for working with core function team members to prepare the R&D Accrual on a quarterly basis.Provide quarterly variance explanations to forecast and prepare schedules to be shared with collaboration partners.Assist in monthly close activities including assigned journal entries (such as prepaid amortization and fixed asset depreciation) and balance sheet reconciliations.Update the financial forecast mode with actuals on a quarterly basis and support the annual company-wide budgeting process.Support end-to-end analysis for Capital Expenditure and Working Capital.Support preparation of reporting materials to be shared with the Corporate Executive Team for quarter-end spend reviews.Help develop, apply, and implement the best tools to analyze data including sophisticated Excel financial models and planning analytical tools.Qualifications:Bachelor's degree in finance, accounting, or a related field (MBA preferred).3-5 years of proven experience in financial planning, analysis, and modeling is required.Ability to present financial information to a non-financial audience, excellent communication, interpersonal, and presentation skills.Detail-oriented and able to perform in a high-pressure environment.Strong analytical thinking and problem-solving skills.Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.Strong organizational skills with the ability to collaborate and partner across teams.High aptitude in Excel Modeling.Biotech experience and experience with NetSuite preferred.Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. The individual will also work closely with the Controller, assisting in the booking of journal entries and supporting the month-end close. This approach relies upon dynamic collaboration between cancer biology, proteomics, informatics, structural biology and medicinal chemistry – with the ultimate goal of realizing the full potential of targeted/precision oncology.Title: Sr. Financial Analyst (NetSuite Experience Required)Location: New York or Boston (Remote)Scorpion Therapeutics is looking for a detail-oriented Sr. Financial Analyst experienced working in a startup biotech environment. This individual will be a key point of analytical support for all R&D program related financial deliverables. The Sr. Financial Analyst will be an integral finance team member supporting reporting activities and analytics for the organization. The company has raised $270M in Series A and Series B financings led by blue-chip investors, including Atlas Venture, Boxer Capital of Tavistock Group, EcoR1 Capital, LLC, Omega Funds, and Vida Venture.Scorpion Therapeutics’ mission is to serve oncology patients by discovering and developing best-in-class and first-in-class, small molecule cancer medicines that address large patient segments with significant unmet medical needs. To accomplish this mission, we are building a highly collaborative team focused on the pursuit of novel approaches to small molecule drug discovery.
Director, GMP Quality Assurance
Company: Entrada Therapeutics
Location: Boston, MA
Posted Aug 07, 2023
Entrada Therapeutics is a tight-knit team of experts in therapeutic development and rare diseases, aiming to transform the treatment of devastating diseases by establishing a new class of medicines. The company is seeking a highly qualified and motivated individual for the Director of GMP Quality Assurance role, responsible for strategic and operational management of manufacturing, testing laboratory, and release and distribution-related Quality activities.
Sr. GxP Digital Systems Specialist
Company: Spark Therapeutics, Inc.
Location: Philadelphia, PA
Posted Aug 08, 2023
Spark Therapeutics is seeking a Sr Digital Systems Specialist to lead the deployment and support of GxP digital systems. The role involves working with end users, cross-functional teams, and software providers. The individual will be responsible for ensuring SDLC processes and Good Documentation Practices are followed. The ideal candidate should have a BS/MS/PhD in Life Science/Engineering/Computer Science, minimum 5 years of experience in the Biotechnology or Pharmaceutical industry, and knowledge of GxP requirements. Preferred skills include experience with SaaS deployments, lab system integrations, and technical project management.
Senior Scientist Translational Sciences
Company: Entrada Therapeutics
Location: Boston, MA
Posted Aug 06, 2023
Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. Third Party Staffing AgenciesEntrada does not accept unsolicited resumes from any source other than directly from candidates. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes. ), ligand binding assays (ELISA or others), rt-PCR, dd-PCR, Western blot, etc.Experience authoring method and study reports as well as contributing to regulatory documentsExperience as a translational program team representative for therapeutics advancing to an IND submission is a plusThe PerksBy becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We also offer a generous transportation stipend to commute as you wish. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer. Entrada Therapeutics is an equal opportunity employer. Scientist IIExcellent oral and written communication skills, including writing, reviewing, and editing scientific documentsWork and drive decision-making within a versatile, multi-regional, and matrix organizationPositive, can do attitude (agile, curious, open-minded, "can-do" mindset); needs to clearly demonstrate ability to remove obstaclesAbility to be scientifically independent and manage workload and expectationsPreferred experienceTrack record of success and measurable contribution in moving therapeutic programs forward through preclinical and clinical development in an academic or industry setting especially in the area of oligonucleotidesWorking knowledge of best practices and current guidance from health authorities for bioanalytical method and biomarker analysisHands on experience with data analysis including binding affinity (BLI, SPR, etc. ResponsibilitiesThe successful candidate will focus on non-clinical biomarkers assay transfer and qualification to manage the data quality of the non-clinical translational works for regulatory submission (IND, etc.) and internal records.Work closely with the Product Development team including Biomarkers, Bioanalytical, DMPK and Toxicology to ensure alignment of activitiesMentor scientist(s) and research associate(s) in the Translational Team.Oversee method qualification activities in the Translational Team including detection range (LOQ and HOQ), calibration curve, QCs, selectivity/specificity, sensitivity, accuracy, precision and stability/recovery as applicable.Contribute to authoring and review of internal stage-gate documents including method qualification reports and sample analysis reports for regulatory and/or discovery purposes.Lead the data quality control and data integrity processes in the Translational Team for all data under the responsibility of the team.If needed, communicate with the clinical translational team and work with the non-clinical biomarker team to support answering specific translational questions. THE NECESSITIESAt Entrada, our passion for science, our devotion to patients and our values drive our behavior:Humanity - We genuinely care about patients and about one anotherTenacity - We are relentless and persistent in the pursuit of developing therapies for patients.Creativity - We are creative problem solvers.Collaboration - We are more than the sum of our parts.Curiosity - We have a growth mindset and push conventional thought and theory.To thrive on our team, you will need to come with:PhD degree in a scientific discipline with 4-6 years of industry/post-doctoral experience for a Sr.
Scientist/Senior Scientist, Translational Research (Pharmacological Sciences)
Company: Voyager Therapeutics
Location: Cambridge
Posted Aug 08, 2023
This is a primarily on-site role with frequent travel to study sites (10-15%).ResponsibilitiesContribute to experimental design, execution, and data analysis for preclinical studies that support Voyager’s capsid engineering platform and therapeutic programs.Serve as a study monitor to review study protocols and address requests/questions from external collaborators and CROsCoordinate with capsid discover team, therapeutic program leads, and operations to set up studies aligned with project requirements and timelines.Monitor study progress and coordinate study activities, such as shipping and receiving of test article and tissue samplesTravel and monitor in-life studies at CRO sites and report site-visit results to Voyager teamsMaintain and update key events in study log and database and timely communicate study status to program teamsReview study report, perform data analysis, and present study results as needed RequirementsAn advanced scientific degree (DVM / PhD) degree in Pharmacology, Biology, or a relevant discipline, with a minimum of 2 years of relevant experience OR a Master’s degree with 5+ years of experience OR a Bachelor’s degree with 8+ years of experienceExperience working with animals is requiredFamiliarity with in vivo techniques, preferably hands-on experience Competency with database, spreadsheet, and presentation applications (e.g., Excel, PowerPoint, Smartsheet, Data entry systems, or similar)Skilled in data analysis using statistical software such as GraphPad Prism, JMP, etc.Outstanding problem-solving skills and ability to multi-task is required.Experience with pharmacology / toxicology study protocol generation, study design, and writing / editing study reports Self-motivated, able to work independently and with team members, highly organized with strong attention to details, and willingness to travel to CRO sitesPreferred qualifications / experienceManagement and / or execution of animal studies at a CRO environment is a plusUnderstanding of relevant biostatistical principles for analysis of animal study dataFamiliarity with bioanalytical and molecular biological techniquesFamiliarity with clinical trials for biologics developmentPrior experience in neuroscience and knowledge of neuroanatomy This is an ideal position for a candidate with a strong background and hands-on experience in preclinical studies, who thrives in a team-oriented, fast-paced, and cross-disciplinary start-up biotech environment.The candidate will contribute to the design and execution of various pharmacology and toxicology studies to support development of novel capsids and biotherapeutics such as AAV-based gene therapy. The Scientist will interact with cross-functional capsid discovery and research program teams to execute in vivo pharmacology, biodistribution, PK/PD, and toxicology studies using AAV-based gene therapy approaches. The successful candidate will work with our multidisciplinary team in Cambridge, Massachusetts. Voyager’s pipeline includes preclinical programs in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. The candidate will also perform quality control and analyze study data and communicate study progress through presentations and written reports. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager’s own pipeline. For more information, visit www.voyagertherapeutics.comJob SummaryVoyager Therapeutics is growing and seeking an experienced and highly motivated Scientist/Senior Scientist to join our Pharmacological Sciences team who shares our passion for the promise of gene therapy. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. About VoyagerVoyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology.
Clinical Data Manager I
Company: Click Therapeutics
Location: Boston, MA
Posted Aug 06, 2023
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below. If you have any questions regarding the validity of a recruitment inquiry or an interview, please contact the Click's recruitment team at [email protected] to confirm before proceeding. Click Therapeutics will conduct interviews face-to-face over Zoom. Competitive Salary with Annual Review | Annual Performance-Based Cash Bonus | Stock options | 5% 401(k) matching | Comprehensive Medical Benefits | Dental | Vision | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Gym Pass | Citi Bike | Professional Development Stipend | Weekly Grubhub Lunches | Generous Paid Parental Leave | Industrious Workspaces | Commuter Subsidies | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More...Equal Employment OpportunityClick Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. This role will support database design/development, medical coding, data systems and quality, and vendor oversight. Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver's License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams). All job postings will be listed on the Click Therapeutics official career page. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. We have a hybrid working model that consists of at least 3 days in office each week.Responsibilities Understanding of clinical data, efficiencies in managing its collection, oversight of its management and assurance of its integrity in the clinical trial process Contribute to the oversight of external service providers, the development, implementation and maintenance of appropriately validated systems/applications for clinical data management, and for providing data management support for clinical trials Contributes to protocol design, study build, validation, clinical databases and data validation activities Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications Designs, modifies and manages study eSource documents Generates routine and ad-hoc reports using internal and external data sources Prepares and distributes project status reports to project team and management Contributes in the development, review, and implementation of departmental SOPs, Work Instructions, templates, guidelines, etc.
Scientist/Senior Scientist, Translational Research (Pharmacological Sciences)
Company: Voyager Therapeutics
Location: Cambridge
Posted Aug 08, 2023
This is a primarily on-site role with frequent travel to study sites (10-15%).ResponsibilitiesContribute to experimental design, execution, and data analysis for preclinical studies that support Voyager’s capsid engineering platform and therapeutic programs.Serve as a study monitor to review study protocols and address requests/questions from external collaborators and CROsCoordinate with capsid discover team, therapeutic program leads, and operations to set up studies aligned with project requirements and timelines.Monitor study progress and coordinate study activities, such as shipping and receiving of test article and tissue samplesTravel and monitor in-life studies at CRO sites and report site-visit results to Voyager teamsMaintain and update key events in study log and database and timely communicate study status to program teamsReview study report, perform data analysis, and present study results as needed RequirementsAn advanced scientific degree (DVM / PhD) degree in Pharmacology, Biology, or a relevant discipline, with a minimum of 2 years of relevant experience OR a Master’s degree with 5+ years of experience OR a Bachelor’s degree with 8+ years of experienceExperience working with animals is requiredFamiliarity with in vivo techniques, preferably hands-on experience Competency with database, spreadsheet, and presentation applications (e.g., Excel, PowerPoint, Smartsheet, Data entry systems, or similar)Skilled in data analysis using statistical software such as GraphPad Prism, JMP, etc.Outstanding problem-solving skills and ability to multi-task is required.Experience with pharmacology / toxicology study protocol generation, study design, and writing / editing study reports Self-motivated, able to work independently and with team members, highly organized with strong attention to details, and willingness to travel to CRO sitesPreferred qualifications / experienceManagement and / or execution of animal studies at a CRO environment is a plusUnderstanding of relevant biostatistical principles for analysis of animal study dataFamiliarity with bioanalytical and molecular biological techniquesFamiliarity with clinical trials for biologics developmentPrior experience in neuroscience and knowledge of neuroanatomy For more information, visit www.voyagertherapeutics.com.Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc.Job SummaryVoyager Therapeutics is growing and seeking an experienced and highly motivated Scientist/Senior Scientist to join our Pharmacological Sciences team who shares our passion for the promise of gene therapy. This platform is fueling alliances with Pfizer Inc., Novartis Pharma AG, Neurocrine Biosciences, Inc., and Sangamo Therapeutics, Inc., as well as multiple programs in Voyager’s own pipeline. This is an ideal position for a candidate with a strong background and hands-on experience in preclinical studies, who thrives in a team-oriented, fast-paced, and cross-disciplinary start-up biotech environment.The candidate will contribute to the design and execution of various pharmacology and toxicology studies to support development of novel capsids and biotherapeutics such as AAV-based gene therapy. The Scientist will interact with cross-functional capsid discovery and research program teams to execute in vivo pharmacology, biodistribution, PK/PD, and toxicology studies using AAV-based gene therapy approaches. The successful candidate will work with our multidisciplinary team in Cambridge, Massachusetts. Voyager’s pipeline includes wholly owned and collaborative preclinical programs in Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and other diseases of the central nervous system, with a focus on validated targets and biomarkers to enable a path to rapid potential proof-of-biology. The candidate will also perform quality control and analyze study data and communicate study progress through presentations and written reports. Voyager’s TRACER™ AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. About&8239;Voyager Therapeutics Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging cutting-edge expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints.