CRISPR Therapeutics jobs - 33 jobs

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Reporting to the Vice President, AID Program Leader and Head of Translational Medicine, the Manager, Infusion Support Operations will be responsible for providing technical and clinical support both internally and externally during clinical trials and other infusion related activities. This role will work on cross-functional study teams for the execution of clinical trial activities, data interpretation, and communication across all company activities as needed. This individual will interface directly with other functions including Clinical Operations, Technical Operations, Quality, Regulatory Affairs. The Manager, Infusion Support Operations will not work in a clinical care role providing direct patient care. The Manager, Infusion Support Operations will be available to provide training, support, and education to various members of the clinical trial site team including but not limited to the stem cell laboratory personnel, the cell therapy transplant team, and clinical research team on CRISPR drug product handling, storage, administration, and monitoring. Responsibilities Participate in the design and implementation of successful infusion protocols, cross functional SOPs, and scientific training material to support clinical trials. Develop infusion and protocol training materials to support internal and external activities Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs, etc.) to ensure successful translation of the clinical protocol into operational deliverables, and participate in the design and development of shared process improvement programs Collaborate with analytical laboratory personnel to assist with drug product thaw and infusion process testing Train clinical sites on receipt, storage, thaw, and infusion procedures related to CRISPR Therapeutics drug products and collaborate with clinical infusion sites to ensure subject safety, adherence to GCP, GxP, GDP and compliance with study protocol Assess and document the effectiveness of education provided to clinical sites, including the activation of new sites to the clinical trial Participate in study site selection by evaluating a site's ability to comply with CRISPR Therapeutics requirements for receipt, storage, thaw, and infusion procedures Provide continuous on-site or remote support for all drug product programs which includes working outside of normal business hours, (i.e. nights, weekends and holidays) Work with cross-functional team to identify opportunities to improve processes and products, including apheresis, as needed by GMP manufacturing; this may include updates to vendor procedures or processes and supporting change documentation by CRISPR Minimum Qualifications Advanced degree in a scientific discipline such as: RN and 5-7+ years' clinical experience, preferably in hospital inpatient or pharmacy setting Pharm D or PhD 1-3+ years' clinical experience, preferably in hospital inpatient or pharmacy setting Excellent oral and written communication skills Experience working with MS PowerPoint, MS Word, MS Excel, Teams and SharePoint as well as Zoom video conferencing Ability to work collaboratively in a fast-paced, team-based matrix environment A thorough understanding of ICH, GCP, GDP and relevant regulatory requirements Strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators. Preferred Qualifications Experience with infusion procedures Experience with clinical education Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission, Sense of urgency in solving problems Entrepreneurial Spirit - Proactive, Ownership mindset CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Base pay range of $118,000 to $130,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The Senior Medical Science Liaison (Senior MSL) serves as a field-based advanced technical, scientific, and medical expert, answers product-related questions from HCPs, and provides clinical/scientific presentations and medical education programs. The Senior MSL is responsible for developing, coordinating, and assuring implementation of Ardelyx's corporate, scientific, and clinical strategies with Key Opinion Leaders (KOLs) within academic, clinical, and healthcare organizations. These scientific exchanges will support and/or expand current therapeutic concepts, as well as ensure the safe and effective utilization of Ardelyx's assets. The Senior MSL builds upon the foundational responsibilities of the MSL by providing advanced scientific engagement, deeper strategic input, and informal leadership across the Field Medical Affairs function. The Senior MSL is recognized as a subject matter expert, mentor to peers, and key contributor to national field medical initiatives as required, playing an important role in aligning field insights with broader medical strategy. Responsibilities: * Serve as the primary field-based medical liaison in providing medical information and scientific exchange to external/internal stakeholders * Identify, establish, and manage collaborative relationships with local, national, and regional medical/scientific leaders/investigators to identify and address scientific needs * Present healthcare professionals and decision makers with accurate, unbiased, balanced, and timely answers to unsolicited requests for information in the therapeutic field responsible * Establish scientific and clinical relationships with thought leaders and academic/community centers to expand research and educational opportunities * Engage in non-product discussions regarding scientific topics (e.g., disease state, diagnosis, epidemiology, unmet medical need, population health, etc.) * Prioritize and work effectively in a self-directed manner in a constantly changing environment, including ability to obtain, integrate and communicate HCP feedback * Participate in advisory boards and other company meetings * Attend key medical and scientific congresses and conferences (local, regional and national) as needed * Lead department-wide projects and participate in cross-functional activities that serve strategic initiatives * Provide strategic insights by maintaining expertise in the therapeutic area and related fields to effectively communicate scientific insights and support strategic objectives * Monitor the competitive environment for advances and trends in the therapeutic area, including new treatment management and therapies, competitive products and provide feedback to internal stakeholders on specific initiatives of competitors * Serves as peer leader to mentor and coach new or junior MSLs, supporting onboarding, training, and field excellence Qualifications: * Doctorate degree (PharmD, PhD, MD, DNP, etc) in biological sciences with 5+ years of MSL Medical Affairs expertise within the therapeutic area or equivalent experience * Advanced Medical/Scientific masters degree (NP, PA) with combined extensive clinical expertise will be considered * Ability to apply technical expertise and solutions to diverse/individualized situations * Critical data analysis skills * Excellent communication & presentation skills * Networking skills and the confidence to interact with senior experts on a peer-to-peer level * Demonstrated ability to integrate and work in cross functional network/matrix * Prior experience in mentorship of medical science liaisons * Demonstrated project management ability * Knowledge of FDA and OIG requirements, as well as the PhRMA Code, including regulations governing compliant scientific exchange * Ability to travel locally, regionally, and nationally as requested/required; up to 70% travel * Valid driver's license The anticipated annualized base pay range for this full-time position is $185,000-$232,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Job Summary The Senior Manager, Quality Validation is responsible for supporting the Validation and Compliance Program at the CRISPR Therapeutics GMP facility located in Framingham, MA. Responsibilities As part of the Site Quality Assurance Team, this position is responsible for: Lead commissioning activities for facility/utilities and onboarding of new equipment to be installed in support of GMP operations. Reviewing and Approving Validation Lifecycle documentation; User Requirements, Functional Requirements Specifications, Design Specifications/Qualifications (DQs), Installation Qualifications (IQs), Operational Qualifications (OQs) and Performance Qualifications (PQs) Supporting the development and implementation of processes aimed to support a compliant, robust and sustainable lifecycle for; facilities/utilities and equipment, computer systems, shipping, analytical methods, cleaning and process. Author/Lead development of controlled documents such as policies, processes, and procedures associated with governing the validation program. Lead the implementation of validation/qualification strategies and serve as a Subject Matter Expert. Performing gap analyses on processes, systems, and practices and recommending and implementing corrective actions and improvements including requalification/revalidation exercises. Approving preventive maintenance/calibration, work orders for facilities/utilities and equipment. Leading deviations, investigations, CAPAs, and Change Controls associated to facilities/utilities and equipment. Reviewing and approving; deviation investigations, Corrective and Preventative Actions (CAPAs), Change Controls and Laboratory Investigations. Ensuring CRISPR's facilities/utilities and equipment processes are maintained in a state of inspection readiness. Participating in supplier qualification audits and supporting internal audits and regulatory inspections. Gathering, preparing, and reporting relevant Quality Metrics. Key internal partners include Quality Assurance, Manufacturing, Facilities, Quality Control, MSAT and Supply Chain. Minimum Qualifications Bachelor of Science with experience in qualification, validation or compliance in a highly regulated GMP regulated environment. Senior Manager: 10+ years of relevant experience Experience in the development, execution, and approval of DQs, IQs, OQs, and PQs is preferred. Experience in deviation investigation, corrective action and change control is expected. Proficiency with environmental and utilities monitoring principles. Experience with implementation of electronic system(s) to ensure compliance. Excellent written and verbal communication skills with the ability to communicate cross-functionally. Innovation and strategic compliance skills including identification and implementation of best practices. Ability to organize and prioritize workload to meet deadlines and company's objectives. Ability to work independently and within cross-functional teams. Ability to mentor less experienced staff members. Preferred Qualifications Prior experience in cell and gene therapy Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. Senior Manager: Base pay range of $130,000 to $150,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary We are looking for a demonstrated technical operations leader with the breadth of professional experience and the drive to work with both internal and external partners to define and implement our vision to assure robust supply of CRISPR products. The successful candidate will be strategic, highly knowledgeable in LNP and oligonucleotide manufacturing with experience in cell therapy and biologics manufacturing as well, have a solid technical operations background, and understand the challenges and impact of managing CMO partners and supply chain operations. They will be responsible for driving execution of CRISPR's program objectives with external manufacturing partners (CMOs and CDMOs) and Product Supply Management including Clinical Supply Chain management for CRISPR managed trials including allogeneic cell therapies and in vivo lipid nanoparticle therapies. This includes all manufacturing oversight for Contract Manufacturers for starting materials, including cell collections from healthy donors, critical components, and drug product. Additionally, the role is responsible for material management for all manufacturing operations, packaging & labeling, shipping, and distribution operations. The function will work closely with the CMC Team for program(s), ensuring the strategy and timelines are clear and aligned before translating these into executional objectives. A key feature of this position is matrix-management of cross-functional teams to execute the program strategic objectives across the lifecycle of the asset. The role will also ensure effective coordination with Clinical Operations and support the successful start-up of new clinical sites and support the needs of expanding clinical trials and commercialization. The incumbent will ensure inventory management for all critical starting materials and critical components produced at our network of CMOs. The leveling for this role reflects the need for a seasoned technical operations leader who has worked across disciplines within CMC and who brings particular depth in external manufacturing and supply chain. This leader will be a strategic thinker who is able to negotiate difficult conversations with, and drive performance at the CMOs and who can distill trade-off decisions into recommendations for escalation to leadership and has significant experience with clinical supply management, hiring and supervising a team and building the core of a scalable and sustainable clinical supply chain team. This role is ultimately accountable for successful execution of the program at the CMOs and across the supply chain network to ensure seamless delivery of drug product to patients globally. As this role interfaces with our external partners, the job may require periods of extensive travel (for example, during tech transfer, PPQ and PAI), nationally or internationally. Routine travel is estimated at 20%. Responsibilities Building and maintaining strategic and operational relationships with CRISPRs CMOs. Manage CMO manufacturing operations and deliverables to ensure supply of materials by disciplined tracking of activities for delivery against objectives; managing changes (documentation, alignment); driving performance (metric setting, monitoring). Manage all clinical supply activities for our clinical trials across allogeneic and in vivo therapeutic areas. Manage all drug product shipping, labeling and distribution to worldwide clinical sites using a network of vendors Manage cross-functional teams, -- team members are accountable as both functional as well as program representatives. Maintain financial responsibility for CMO and vendor spend, managing the budget allocation, negotiating work statements, ensuring purchase requisitions are raised and PO's are reconciled. Provide regulatory filing support (IND, BLA, etc.) as needed. Oversee CMO due diligence during new CMO selection to vet capabilities, risks and investments required. Identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions. Establish alignment of objectives and priorities in close coordination with CMC team, clinical operations and other functions as needed, representing the CMO(s) in strategic decisions for the program. Engage, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both CRISPR and the CMO comply with commitments. Developing strong relationships with internal functional leaders, leveraging these relationships for development and alignment of the program objectives. Maintain information flow during project execution from the Technical Operations team to enable monitoring of the relationships with CDMOs and other vendors. Coordinate and manage CMO governance meetings, in partnership with CMO program manager and/or business lead. Provide leadership and management support for activities to drive a fast paced, highly efficient learning culture. Be a champion of a highly collaborate, transparent, data driven, ‘make it happen', culture. Minimum Qualifications BS/MS in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific discipline. 15-20+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development. Fluent in cGMP requirements Experience in working with third parties and CDMOs for manufacturing operations and clinical supply chain management activities. Ability to influence and effectively communicate and collaborate with senior management stakeholders both internally and externally. Proven ability to mentor and coach more junior team members and develop a strong team. Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion. Strong leadership and an innate ability to collaborate and build relationships is critical. Flexible and comfortable working with ambiguity as the program priorities follow the science and clinical outcomes. Self-driven, independently motivated, data driven and excellent problem-solving ability. Available to travel both domestically and internationally. Preferred Qualifications Advanced degree such as PhD in Life Sciences or a related field and/or an MBA. Strong background in aseptic processing. Experience in commercialization of new assets and management of post-approval lifecycle. Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Executive Director: Base pay range of $260,000 to $290,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary The Principal Process Engineer is responsible for design, construction, commissioning and technical support of process systems at the state-of-the-art cell therapy manufacturing facility being built in Framingham, MA. The successful candidate will be creative, team oriented and have hands on experience in Engineering support of cGMP manufacturing operations and design of new processes, and a strong grasp process equipment within a multi-product, FDA regulated, cGMP facility. The ideal candidate will participate in all levels of design, startup, and operations including on the floor support of systems and issues. They will serve as a consultant to management on major engineering challenges pertaining to policies, plans, and objectives and will report directly to Head of Process Engineering. Responsibilities Design, specification, and selection of single use equipment systems Generate system user requirement specifications (URS) System SME representative in design reviews Support automation and monitoring systems integration Generate facility capacity models and design the development of COGs models Provide and delegate technical support of Commissioning & Qualification activities (approval of protocols and reports) Technical guidance SME and deliver analysis for the resolution of equipment related deviations and investigations Lead implementation of process improvement projects through change control Co-author department procedures and specifications Minimum Qualifications Bachelor of Science Degree in Chemical, Mechanical, or Bio-Engineering with 15+ years of relevant work experience or PhD and 8+ years of experience Experience with specification and implementation of single use systems (tangential flow filtration systems a plus) Excellent attention to detail and capable of managing multiple priorities with aggressive timelines Strong leadership, interpersonal communication skills and ability to work effectively with internal cross functional teams and external partners and vendors Proficient at applying good engineering practices, industry guidance, and regulatory requirements Creative problem solver and decision maker Preferred Qualifications Experience with Kneat and Blue Mountain CMMS Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. Principal Process Engineer, LNP: Base pay range of $168,000 to $180,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Reporting to the Director, Supply Chain, the Senior Manager of Supply Chain will be responsible for managing and optimizing global supply to ensure timely availability of clinical supplies for clinical trials. This role requires the incumbent to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization. The ideal candidate will have a deep understanding of end-to-end supply chain networks and strong analytics to deliver cost-effective supply chain solutions while balancing multiple business objectives. The position requires enthusiasm, passion, high attention to detail, and a desire to create new medicines for patients. Responsibilities Manage the supply planning and inventory management for finished goods, drug products, drug substances, and critical components across multiple clinical programs. Collaborate with CMC, Clinical Operations, QA, Regulatory to generate label/package specifications, oversee approvals for multiple countries/regions, and provide support for IND/IMPD/CTA filings as required. Plan and oversee the secondary packaging, labeling activities with CMOs, and facilitate the process through release and global distribution. Work closely and proactively with internal/external stakeholders to ensure seamless operation of clinical trials and address any challenges. Identify and implement innovative and cost-effective solutions to optimize the supply chain network amid ambiguity and rapid growth. Participate/lead investigations, change management in close collaboration with Quality, as applicable. Identify issues and/or risks with meeting clinical supply requirements and suggest solutions to meet timelines. Author/revise SOPs and business process work instructions. Define and implement KPIs/metrics related to supply and demand. Manage budget forecasting activities with the supply chain function. Minimum Qualifications BS/BA in supply chain management or related fields. Senior Manager: 10+ years of experience working within a cGMP clinical supply chain function in the biotechnology or pharmaceutical industry Proven success in leading cross-functional projects to establish new supply chain capabilities. Demonstrated expertise in supply planning, inventory management, and demand forecasting. Excellent communication and interpersonal skills with the ability to work with uncertainty and thrive in a fast-paced, dynamic environment. Exceptional attention to detail, analytical and problem solving and critical thinking skills. Ability to influence others and work independently and in a team environment. Experience working closely with Manufacturing, CMC, Regulatory, Quality, Clinical teams, and logistics providers. Preferred Qualifications Experience with cell and gene therapy supply chains highly preferred. Additional specific qualifications in clinical supply chain planning including APICS CPIM or CSCP, and related professional certifications. Solid understanding of regulatory requirements for clinical supplies with experience applying them to packaging/labeling and distribution operations. Strong user in data analytics tools and project planning tools. Knowledge of trade compliance and VAT/GST reclamation Knowledge of building and enhancing IRT systems Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. A sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Senior Manager: Base pay range of $130,000 to $150,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. We are seeking an experienced and highly strategic Director, Payer Marketing to join our dynamic team. This individual will serve as a key business partner to support and drive various corporate, brand, and market access initiatives. This role will lead the development and execution of payer and access marketing strategies and tactics aimed at securing, maintaining, and optimizing product access across B2B customers, including payers, dialysis organizations (DO) and other stakeholders in the United States healthcare ecosystems. Responsibilities: Lead the development and implementation of B2B access marketing tactics and pull-through resources. This may include materials for teams calling on payers, dialysis organizations, or health care providers (for reimbursement needs) Develop account-specific tactical recommendations based on customer type, business needs, and competitive landscape, ensuring timely and profitable access Partner within Market Access & Patient services and other cross-functional commercial partners, including: brand leadership, commercial operations, and HEOR, medical, Regulatory, Patient Services, Finance, Trade, Account Management to ensure alignment of payer marketing strategies with overall business objectives Oversee strategic alignment and execution with National and Regional Market Access account teams on tactical plans aligned with organizational and brand strategies Identify and execute marketing needs for field access managers, including reimbursement marketing materials that support access and pull-through objectives Implement key tactics for various payer channels (e.g., government, commercial) Partner with Data Analytics to deliver market insights that inform payer strategies, tactics, and promotional plans Partner with Data, Analytics, and Operations to execute market research needs and gaps (e.g., Advisory Boards) Act as the Market Access point of contact on cross-functional brand teams, fostering collaboration and ensuring strong market access representation Represent Market Access in Medical, Legal, and Regulatory (LMR) review meetings Manage the payer marketing budget, agency of record, and external vendors as necessary Qualifications: Bachelor's degree in marketing, business, or a related field, MBA preferred, with 9 - 12 years of experience or relevant experience, particularly in the pharmaceutical/ biopharma industry or equivalent experience In-depth understanding of payer and reimbursement market dynamics, including commercialization, pricing, reimbursement, and access Proven ability to develop and execute pull-through plans specific to payers Strong project management skills, with the ability to drive projects independently, establish budgets, and meet deadlines Exceptional interpersonal skills, with a focus on relationship-building through transparency and trust Ability to collaborate, influence, and work with a wide range of internal and external stakeholders to achieve results Experience managing multiple priorities and meeting deadlines under business constraints Strong communication skills with the ability to craft and deliver compelling narratives Proven success in working collaboratively across the business to design and execute solutions to complex challenges preferred Ability to thrive in a fast-paced, evolving environment Work Environment: Travel will vary depending on the needs of the department. Remote location will be considered but periodic office attendance will be required based upon the needs of the business. The anticipated annualized base pay range for this full-time position is $219,000 - $267,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. Position Summary Reporting to the Executive Director of Clinical Development, the Associate Director or Director (AD/Dir) will provide clinical and scientific input and medical monitoring to early-stage clinical development programs. The AD/Dir will have a significant role in clinical study oversight and deliverables, including review of patient data, input on clinical trial design and execution, and preparation/presentation to leadership, at conferences, and to safety oversight committees. Responsibilities • Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigators brochure, eCRFs, ICFs, CSRs) • Perform review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations • Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study • Communicate a clear overview of trial results • Collaborate with internal stakeholders (including clinical operations, data management, statistics, safety, regulatory affairs, among others) to ensure translation of the clinical protocol into operational deliverables • Review and synthesize scientific literature and competitive intelligence to support study and program strategy • Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials • Drive and support preparation of scientific material for conference presentations or publications • Contribute to the authoring and revision of regulatory submissions • Perform analyses and generate scientific slide decks based on clinical, translational and other datasets Minimum Qualifications • Medical Doctorate (MD, DO, or equivalent ex-US medical degree). o Associate Director: 5+ years of clinical/related research experience (including residency and fellowship) o Director: 8+ years of previous experience in clinical/related research (including residency and fellowship) or industry experience • Excellent oral and written communication skills and analytical skills • Ability to work collaboratively in a fast-paced, team-based matrix environment; ability to assume multiple roles and responsibilities and meet stretch goals • Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators Preferred Qualifications • Clinical experience in cardiovascular diseases; clinical or research experience with genetic medicines, prior work on cardiovascular clinical trials a plus • Advanced clinical training or a scientific degree (e.g. PhD, PharmD, MPH, etc.) is a plus. • Industry experience Competencies • Collaborative - Openness, One Team • Undaunted - Fearless, Can-do attitude • Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. • Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Associate Director: Base pay range of $150,000 to $190,000+ bonus, equity and benefits Director: Base pay range of $185,000 to $225,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. 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. 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. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts Summary Tango has an exciting opportunity to join the team as Manager, Clinical Sciences. In this role, you will support the development, planning, execution, and evaluation of clinical studies to ensure scientific integrity and accurate interpretation of data. You will report to the Senior Medical Director, Clinical Development. Your Role: Support the clinical development of investigational oncology therapies by contributing to study design discussions. This includes patient population definitions, endpoint selection, protocol feasibility assessments, and literature research of medical publications to extract data and relevant scientific information Partner with cross-functional teams to support the timely start-up and execution of clinical trials in accordance with regulatory requirements and Good Clinical Practice (GCP) Collaborate with data management, clinical operations, biostatistics, pharmacovigilance, and other clinical teams to ensure alignment on study milestones and deliverables Contribute to the development and review of clinical documents including protocols, informed consent forms, Investigator's Brochures, clinical study reports, and regulatory submission materials Assist with reviewing and writing other clinical trial documents and publications as needed Conduct targeted literature reviews and extract relevant data from medical publications to support clinical development strategy and regulatory submissions Provide clinical and scientific support to clinical sites and CROs, including assistance with protocol training, site communications, and query resolution Review clinical data in EDC systems including data cleaning, to identify safety signals and trends, summarize findings, and contribute to interim data reviews and study decision making Collaborate with data management to develop and maintain clinical data review plans, including defining data review schedules, identifying critical data points for monitoring, and establishing processes for ongoing data quality oversight Prepare clear, concise data summaries and study status updates for internal team meetings and cross-functional review Perform other related duties and responsibilities as assigned What You Bring: MS, PharmD, PhD, RN, or PA degree in a relevant scientific or clinical discipline At least 5 years' experience in clinical science, or research At least 2 years' experience in oncology Understanding of clinical trial design, regulatory guidelines (FDA/ICH), and GCP principles Strong analytical skills with proficiency in interpretation of clinical data and identification of clinical trends Excellent written and oral communication skills, with the ability to convey complex scientific concepts clearly Proven success operating in a high pace, dynamic team setting Collaborative mindset with eagerness to learn and grow within clinical development 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. Salary range $113,600-$170,400 USD

Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. The Director, Cyber Security Operations is the senior leader responsible for developing, implementing, and operating Ardelyx's global cybersecurity program. This role provides strategic direction, builds and leads a high-performing security organization, and ensures the confidentiality, integrity, and availability of corporate systems, data, and cloud environments. The ideal candidate is a seasoned cybersecurity leader who combines deep technical expertise with strong strategic vision, operational rigor, and the ability to communicate effectively with executives, auditors, engineers, and cross-functional partners. This leader will own and execute a scalable security roadmap that aligns with Ardelyx's business objectives, regulatory requirements, and evolving threat landscape while continuously improving the organization's overall risk posture. Responsibilities: Own and execute the enterprise cybersecurity strategy, roadmap, and operating model aligned with business and technology objectives Build, lead, and mature a high-performing security organization spanning engineering, operations, governance, and risk management Serve as the primary advisor to executive leadership on cybersecurity risk, threat exposure, and security investments, enabling informed, risk-based decision-making Establish, enforce, and continuously improve security policies, standards, and controls while driving a strong culture of security awareness across the organization Oversee enterprise threat detection, monitoring, and incident response capabilities across on-prem, cloud, and SaaS environments Lead incident response preparedness and execution, including tabletop exercises and real-time coordination with Legal, HR, Compliance, and Communications during security events Own the security architecture and tooling strategy, including endpoint, cloud, identity, SaaS, network, and web security platforms Drive security automation and orchestration (SOAR) to improve response consistency and reduce MTTD/MTTR Apply defense-in-depth principles enterprise-wide, proactively identifying control gaps and implementing remediation or compensating controls Lead security platform consolidation and vendor management to standardize controls, reduce tool sprawl, and lower total cost of ownership, while ensuring compliance and audit readiness Qualifications: Bachelor's degree in Information Security, Computer Science, Information Technology, or related field with 9 - 12 years of progressive cybersecurity experience or equivalent experience 5+ years in a senior leadership role, with responsibility for enterprise security strategy, operations, and risk management. Industry-recognized cybersecurity certifications preferred, such as: CISM, CISSP, CRISC, CCSP Proven hands-on and leadership experience across core security domains, including identity and access management (IAM, MFA, SSO), cloud security (Azure/AWS), endpoint protection (EDR/XDR), network security, incident response, and threat management Demonstrated experience leading enterprise security programs, including SIEM, vulnerability management, security automation, compliance frameworks (ISO 27001, SOC 2, NIST, HIPAA, GDPR), vendor management, audits, and contract negotiations; familiarity with DevOps, CI/CD, and infrastructure-as-code is a plus Strong executive communication skills with the ability to translate technical risk into business impact Recognized as a trusted security leader and mentor across IT and cross-functional teams Proven ability to influence standards, patterns, and best practices at an enterprise level Location: Waltham, Massachusetts The anticipated annualized base pay range for this full-time position is $221,000 - $270,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary The Principal Process Engineer is responsible for design, construction, commissioning and technical support of process systems at the state-of-the-art cell therapy manufacturing facility being built in Framingham, MA. The successful candidate will be creative, team oriented and have hands on experience in Engineering support of cGMP manufacturing operations and design of new processes, and a strong grasp process equipment within a multi-product, FDA regulated, cGMP facility. The ideal candidate will participate in all levels of design, startup, and operations including on the floor support of systems and issues. They will serve as a consultant to management on major engineering challenges pertaining to policies, plans, and objectives and will report directly to Head of Process Engineering. Responsibilities * Design, specification, and selection of single use equipment systems * Generate system user requirement specifications (URS) * System SME representative in design reviews * Support automation and monitoring systems integration * Generate facility capacity models and design the development of COGs models * Provide and delegate technical support of Commissioning & Qualification activities (approval of protocols and reports) * Technical guidance SME and deliver analysis for the resolution of equipment related deviations and investigations * Lead implementation of process improvement projects through change control * Co-author department procedures and specifications Minimum Qualifications * Bachelor of Science Degree in Chemical, Mechanical, or Bio-Engineering with 15+ years of relevant work experience or PhD and 8+ years of experience * Experience with specification and implementation of single use systems (tangential flow filtration systems a plus) * Excellent attention to detail and capable of managing multiple priorities with aggressive timelines * Strong leadership, interpersonal communication skills and ability to work effectively with internal cross functional teams and external partners and vendors * Proficient at applying good engineering practices, industry guidance, and regulatory requirements * Creative problem solver and decision maker Preferred Qualifications * Experience with Kneat and Blue Mountain CMMS Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. Principal Process Engineer, LNP: Base pay range of $168,000 to $180,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. Position Summary This position will be responsible for building, managing, and administering CRISPR's Quality Management System, specifically the Deviation, Change Control and CAPA processes. The candidate will administer Kivo QMS and will ensure compliance with established procedures. Enhancement of existing procedures, and creation of new best practices will be a critical component of this role. Responsibilities Lead the QMS Program, specifically the deviation, CAPA, & change control programs Develop, improve, and administer the QMS Program Act as Kivo QMS business administrator Provide subject matter expertise to improve the QMS Develop and improve Quality department procedures Train new users on Kivo QMS Ensure compliance with approved CRISPR procedures as they relate to the creation and approval of QMS records Coordinate periodic review of QMS records Generate metrics to ensure on-time record closure and identify corrective actions Develop and present QMS metrics to management Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions Meet with QMS record owners and participants to ensure proper system usage Support internal and external audits related to the QMS Enhance the Quality Culture by being a proactive and professional resource for the business. Minimum Qualifications Minimum of 10+ years' experience in related Biopharmaceutical QMS roles Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred BA or BS is preferred though long-time experience in QA may be acceptable Strong organizational skills and attention to detail Strong interpersonal skills Computer skills and previous experience with eQMS Ability to provide subject matter expertise regarding QMS implementation and administration Systems Administration experience Preferred Qualifications MS or advanced degree Experience with Gene Therapy / Cell Therapy products Previous experience with Kivo QMS Computer System validation experience Entrepreneurial and results driven Project Management experience MS Office proficiency Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Senior Manager: Base pay range of $130,000 to $150,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary The Statistical Programming Contractor will provide technical support for statistical programming activities for assigned clinical studies, FDA submissions, and the development of initiatives. Responsibilities Design, develop, evaluate, validate and modify computer programs using SAS to analyze and evaluate clinical data. Have thorough knowledge of CDISC theory and implementation guidelines, able to create and validate CDISC standard datasets Program edit checks and produce quality tables, figures and listings in a timely fashion and high quality. Work closely with Clinical Operations, Data Management and Biostatisticians on various clinical projects so that data analysis can be performed in a timely fashion. Minimum Qualifications Bachelor's Degree in Statistics, Mathematics, and/or Computer Science/IT background. Master's Degree preferred. Minimum 3 years of statistical programming in a pharmaceutical/biotech or CRO setting (depending on level) Strong knowledge in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA. Strong hands-on SAS programing skills and working experience for clinical trial reporting for SDTM, ADaM, Table, figure, and Listing. Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language. Advanced knowledge of GCP/ICH standards, 21 CFR Part 11. Preferred Qualifications Strong ability to work within cross-functional teams. Excellent interpersonal, organizational, and multi-tasking skills. Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Base pay range of $70.00 - $80.00 per hour. The hourly rate provided is the reasonable estimate for this contract position. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary We are seeking a Business Development and Strategy professional to support in-licensing and external partnering, strategic planning, and investor relations. The successful candidate will facilitate new partnership transactions, including developing background materials, coordinating deal processes, and negotiating partnership agreements; generate materials to support investor and pharmaceutical company partnering meetings. The output from these activities will inform the planning of current programs, the evaluation of new disease areas, partnership decisions, and overall corporate strategy. This person will join a strong team in Boston, MA, and work closely with colleagues from across the organization. This is an exciting and interdisciplinary role for a highly qualified and motivated individual. The successful candidate will combine a deep scientific background with a broad strategic perspective on opportunities for CRISPR gene editing. This person will have experience conducting primary and secondary research, building effective slide presentations and other communication materials, performing quantitative analysis and financial modeling, and generating insights and recommendations to inform strategic decision-making. The ideal candidate will have prior experience in business development, strategy, or top-tier consulting in the field of drug development. Crucially, this individual needs to relish tackling new challenges and wearing multiple hats within a company and bring a sense of urgency for developing important new medicines for devastating diseases. Responsibilities Support the facilitation of new deals, both involving asset/technology in-license and out-license, including engaging with external parties and working with internal cross-functional teams to oversee deal processes Responsible for gathering competitive intelligence and disseminating data to the relevant parties Perform research and analysis to support corporate strategy, pipeline strategy development and the identification and evaluation of new partnership opportunities Generate materials (slide presentations, written documents, etc.) to support investor relations and other external communications Manage existing partnerships, including renegotiation of deal terms over time and management of project timelines and activities Propose new strategic initiatives and collaborations to senior management Work effectively with scientific, legal, finance, and executive leadership teams Minimum Qualifications Senior Manager: 6+ Years of experience at a biopharma company in business development and/or strategy, or at a leading consulting firm or venture capital firm, with a bachelor's degree 4+ Years of experience at a biopharma company in business development and/or strategy, or at a leading consulting firm or venture capital firm with an advanced degree Associate Director: 10+ Years of experience at a biopharma company in business development and/or strategy, or at a leading consulting firm or venture capital firm, with a bachelor's degree 8+ Years of experience at a biopharma company in business development and/or strategy, or at a leading consulting firm or venture capital firm with an advanced degree Bachelor's degree in a scientific or business field, strong interest and comfort in analyzing basic science and clinical data Outstanding oral and written communication skills, significant experience with PowerPoint and Excel Ability to work in a fast-paced, team-oriented environment High energy and a passion for developing important new medicines for patients with devastating diseases Strong proficiency in building relationships with internal and external partners Preferred Qualifications Master's degree or PhD in a scientific or business field Experience in gene editing, LNP, in vivo, cell therapy, and/or gene therapy programs Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Senior Manager: Base pay range of $150,000 to $170,000+ bonus, equity and benefits Associate Director: Base pay range of $185,000 to $205,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Reporting directly to the Vice President of Corporate Development and Strategy, the Director of Alliance Management will manage and optimize strategic collaborations with global pharmaceutical and biotech partners.The ideal candidate has hands-on experience managing complex, multi-functional alliances, proactively resolving issues, and driving structured decision-making that leads to clear outcomes. Note; this position will be based out of Waltham, MA and would require relocation outside of MA. Responsibilities:Alliance Leadership & Governance Serve as the primary alliance lead for strategic partnerships, owning day-to-day relationship management Design, implement, and run alliance governance structures (JSCs, sub-teams, escalation pathways) Ensure decisions are made efficiently, documented clearly, and executed across both organizations Issue Resolution & Decision Enablement Anticipate and surface alliance risks (operational, strategic, financial, contractual) Lead cross-functional problem-solving efforts to address issues that arise Drive discussions that result in timely decisions and measurable outcomes Cross-Functional Execution Coordinate closely with R&D, Tech Ops, Commercial, Legal, Finance, and BD teams Support operational execution of alliance agreements and ensure adherence to contractual obligations Track milestones, deliverables, and performance metrics Partner Relationship Management Build trusted, senior-level relationships with partner counterparts Balance collaboration and accountability, advocating for Ardelyx's interests while maintaining strong partnerships Prepare and lead executive-level communications and governance meetings Strategic & Portfolio Support Provide alliance insights to inform broader corporate strategy and portfolio decisions Support business development during deal structuring and diligence to ensure alliances are operationally sound post-signing Contribute to best practices, playbooks, and continuous improvement of alliance management processes Qualifications: Bachelor's degree with 8-10 years of experience in alliance management, business development, corporate development, or related roles in biotech/pharma or equivalent experience Proven track record managing complex, high-stakes alliances with external partners Demonstrated ability to drive processes that lead to decisions and results, especially in ambiguous or contentious situations that require escalation, renegotiation, or restructuring Strong understanding of alliance governance, contract interpretation, and cross-functional execution Exceptional communication, influence, and stakeholder-management skills The anticipated annualized base pay range for this full-time position is $210,000 - $256,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

Description Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Relying on deep therapeutic area expertise, scientific knowledge, and a superior understanding of Medical Affairs and the compliant interplay with commercial brand teams, this role is responsible for leading the strategic development and overall tactical execution of dedicated late stage pipeline launch, as well as, all current on market indications with focus on Nephrology. This position is highly visible, collaborative, and influential and will serve as the integrated medical affairs representative for cross-functional senior leadership teams including but not limited to: Commercial Brand teams, Clinical Development, Government Affairs, Marketing, as well as developing and advancing relationships with select external KOLs This individual will report to the head of Medical Affairs. Responsibilities: Develop, prioritize, and execute the overall US medical therapeutic area strategy including the annual monitoring and adaptations required from integrated learnings across both medical and brand teams Develop and execute the strategic direction for responsible therapeutic area within medical affairs including but not limited to the development of publication evolution, evidence generation priorities, medical education assessment, annual plan and key areas of interest, field message evolution and advancing the scientific narrative in close collaboration with the corresponding internal medical affairs functions Maintain a superior degree of awareness of clinical landscape, guidelines, scientific literature and competitive threats Build and advance identified priority external relationships with senior KOLs and physicians who are clinical leaders and influencers to form a relevant and sustainable strategy reflective of patient, payor, and other US customer needs Present disease state and clinical data to a variety of internal and external audiences (e.g., government, policy, payors, etc.) Oversee and manage execution of scientific Review and input for relevant medical review committees Oversee and manage execution of scientific review and input for relevant promotional review committees Work with medical information to triage the handling of escalated Medical Information Requests including providing research and language to include in the development of SRLs Provide input and support for field medical initiatives and execution as required from MSL lead Consolidate and share integrated insights with other functions within R&D (eg: clinical development, regulatory) Primary partner to Commercial team for the education and training of speakers on disease state and clinical data promotional presentations Ensure continuous development and training of the medical affairs and MSL team with regards for disease area expertise Qualifications: Advanced Scientific degree, MD/DO preferred, with 10 - 12 years of progressive medical or scientific affairs experience within the pharmaceutical or biotech industry or equivalent experience Superior pharmaceutical industry experience within Medical Affairs Demonstrated advanced understanding of relevant connections and integration points between Medical Affairs and stakeholders across the R&D and Commercial functions Superior experience working in a complex matrix management environment In-depth knowledge of study methodology, data analysis techniques, and critical review of publications is strongly preferred Strategic mindset with a focus on collaboration and excellence Superior organizational skills including attention to detail and prioritization Ability to collaboratively work and establish relationships with a multidisciplinary team, across internal and external stakeholders Superior critical thinking, communication and writing skills Ability to travel to various meetings May require approximately 20-30% travel The anticipated annualized base pay range for this full-time position is $273,000-$336,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary We are seeking a talented and motivated Global Regulatory Lead (GRL) to join our growing Research and Development organization at the Associate Director/Director level. As a key member of the core product development team, you will have the opportunity to provide strategic directions to ensure successful product development and approval in alignment with company objectives. In advancing several product candidates into clinical stage, CRISPR Therapeutics will offer the right individuals the opportunity to devise and implement creative global regulatory development strategies to bring novel products to patients as quickly, robustly and efficiently as possible, and to shape the regulatory framework in which we operate. The position provides an excellent opportunity to apply current knowledge and gain experience in the fast growing and advancing field of gene and cellular therapies. As the company grows, you will have the opportunity to contribute to building the organization and further advance your leadership position. Responsibilities Provide strategic vision and innovative scientific and regulatory leadership in defining a comprehensive science-based, solution-oriented global regulatory development strategy for assigned projects to achieve high quality and timely product registration and effective regulatory agencies interactions aligned with stakeholders needs. Pro-actively establish and maintain high-quality working relationships with regulatory agencies as appropriate for assigned therapeutic areas and products. Monitor and assess impact of relevant global regulations and the evolving regulatory, scientific and competitive environment. Represent Global Regulatory Affairs on assigned core product development teams and other relevant teams and/or governance bodies, including external alliances and partnerships. Provide regulatory expertise and guidance to product development teams and other functions of the company as needed, including by applying appropriate competitive decision making. Provide regulatory direction in product development to align medical need with business objectives in the context of available and expected scientific data, and regulatory guidance and precedent. Lead the planning and implementation of global regulatory filings (IND/CTAs, BLAs). Oversee all submission activities and regulatory writing for regulatory documentation including but not limited to meeting briefing packages, requests for special designations, INDs, BLA/MAAs and routine submissions. Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents). Present regulatory plans, risk assessments and strategies, pertaining to the assigned project(s), including innovative strategic options which communicate the associated risks. Minimum Qualifications A bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science. Prior regulatory experience with a demonstrated track record of significant accomplishments: 10+ Years of relevant experience with an advanced degree 12+ Years of relevant experience with a bachelor's degree Candidates must have a thorough knowledge and understanding of pharmaceutical and/or biological product development and regulatory requirements for product development and approval in more than one key region (i.e. EU, US, New Zealand, or Australia). Experience interfacing with regulatory agencies and proven skill at developing, communicating and implementing successful global regulatory strategies. Demonstrated ability to communicate and write clearly, concisely, and effectively Experience driving documents through from start to finish with tight timelines and cross-functional study teams Strong analytical skills and ability to interpret and present complex data clearly Independently motivated, and good problem-solving ability Preferred Qualifications An advanced degree (MS/MBA, PhD or MD) Current experience developing new product regulatory strategies including submissions and approvals from early development through marketing applications. Working knowledge of cellular and gene therapies or biologics development and manufacture, and relevant global regulatory environment. Detailed knowledge of requirements for preparation of key regulatory documents for INDs, CTAs, BLAs and annual reports. Prior preclinical or clinical regulatory foundation. Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred Experience working in a small biotech environment Detailed knowledge of requirements for preparation of key clinical and regulatory documents for INDs, CTAs, BLAs and annual reports Competencies • Collaborative - Openness, One Team • Undaunted - Fearless, Can-do attitude • Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. • Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Base pay range of $170,000 to $195,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary We are seeking a talented and motivated Global Regulatory Lead (GRL) to join our growing Research and Development organization at the Associate Director/Director level. As a key member of the core product development team, you will have the opportunity to provide strategic directions to ensure successful product development and approval in alignment with company objectives. In advancing several product candidates into clinical stage, CRISPR Therapeutics will offer the right individuals the opportunity to devise and implement creative global regulatory development strategies to bring novel products to patients as quickly, robustly and efficiently as possible, and to shape the regulatory framework in which we operate. The position provides an excellent opportunity to apply current knowledge and gain experience in the fast growing and advancing field of gene and cellular therapies. As the company grows, you will have the opportunity to contribute to building the organization and further advance your leadership position. Position Summary Reporting to the Vice President, AID Program Leader and Head of Translational Medicine, the Director will provide clinical and scientific input and medical monitoring to early-stage clinical development programs in autoimmune diseases. The Director will have a significant role in clinical study oversight and deliverables, including review of patient data, input on clinical trial design and execution, and preparation/presentation to leadership, at conferences, and to safety oversight committees. Responsibilities Lead the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigators brochure, eCRFs, ICFs, CSRs) Perform review of clinical trial data (safety and efficacy), including medical monitoring and assessing for consistency and completeness and providing assessments and recommendations Serve as the clinical development lead during the conduct of the study Communicate a clear overview of trial results Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables Review and synthesize scientific literature and competitive intelligence to support study and program strategy Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials Drive and support preparation of scientific material for conference presentations or publications Contribute to the authoring and revision of regulatory submissions Perform analyses and generate scientific slide decks based on clinical, translational and other datasets Minimum Qualifications Medical Doctorate (MD, DO, MBBS) Advanced clinical training or a scientific degree in immunology (eg PhD, PharmD, MPH, etc) a plus 8+ years of previous experience in clinical or related research preferred Excellent oral and written communication skills and analytical skills Ability to work collaboratively in a fast-paced, team-based matrix environment; ability to assume multiple roles and responsibilities and meet stretch goals Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators Preferred Qualifications MD with a strong clinical or biopharmaceutical background in caring for patients with autoimmune diseases Clinical or research experience in immunology or neurology Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Base pay range of $190,000 to $220,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. Position Summary This position will be responsible for building, managing, and administering CRISPR's Quality Management System, specifically the Deviation, Change Control and CAPA processes. The candidate will administer Kivo QMS and will ensure compliance with established procedures. Enhancement of existing procedures, and creation of new best practices will be a critical component of this role. Responsibilities * Lead the QMS Program, specifically the deviation, CAPA, & change control programs * Develop, improve, and administer the QMS Program * Act as Kivo QMS business administrator * Provide subject matter expertise to improve the QMS * Develop and improve Quality department procedures * Train new users on Kivo QMS * Ensure compliance with approved CRISPR procedures as they relate to the creation and approval of QMS records * Coordinate periodic review of QMS records * Generate metrics to ensure on-time record closure and identify corrective actions * Develop and present QMS metrics to management * Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions * Meet with QMS record owners and participants to ensure proper system usage * Support internal and external audits related to the QMS * Enhance the Quality Culture by being a proactive and professional resource for the business. Minimum Qualifications * Minimum of 10+ years' experience in related Biopharmaceutical QMS roles * Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred * BA or BS is preferred though long-time experience in QA may be acceptable * Strong organizational skills and attention to detail * Strong interpersonal skills * Computer skills and previous experience with eQMS * Ability to provide subject matter expertise regarding QMS implementation and administration * Systems Administration experience Preferred Qualifications * MS or advanced degree * Experience with Gene Therapy / Cell Therapy products * Previous experience with Kivo QMS * Computer System validation experience * Entrepreneurial and results driven * Project Management experience * MS Office proficiency Competencies * Collaborative - Openness, One Team * Undaunted - Fearless, Can-do attitude * Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. * Entrepreneurial Spirit - Proactive. Ownership mindset CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Senior Manager: Base pay range of $130,000 to $150,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************