CRISPR Therapeutics jobs in Boston, MA - 21 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 Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment. Responsibilities Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting. Transfer raw material inside cleanroom suite using sanitizing reagents or equipment. Participates in technology transfer from Process Development to the Manufacturing group. Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups. Ensures all materials and equipment are identified and available in time for manufacturing operations. Execute standard work per manufacturing schedule Participate in Quality investigations and resolutions. Ensure cGMP compliance through consistent execution. Other duties and projects as assigned to meet departmental requirements. Minimum Qualifications Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields Available to work a flexible schedule as needed. Ability to don cleanroom garments and work within a classified environment (Grade B and C) Knowledge of GMP and industry standards T-Mix and TFF experience preferred Fluency in Windows and Microsoft Office applications Attentive to detail and accuracy Ability to effectively communicate and collaborate with internal stakeholders is essential 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 Ability to lift 40 pounds Ability to stand for 6 hours in a clean room environment Self-driven, independently motivated, data driven and excellent problem-solving ability 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. Manufacturing Associate: Base pay range of $35.00 per hour to $42.00 per hour + 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: ***********************************************

A leading biopharmaceutical company in Massachusetts is seeking a Director of Alliance Management to oversee strategic collaborations with global partners. You will lead crucial initiatives in alliance governance, manage complex relationships, and drive decision-making processes across multifunctional teams. The right candidate will have extensive experience in business development and a proven ability to navigate challenging situations, ensuring strong partnerships while advocating for organizational interests. This role offers a competitive salary and comprehensive benefits package. #J-18808-Ljbffr

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. 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 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: ***********************************************

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.

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 our growing Biometrics team as a Senior Manager, Statistical Programming, reporting to the Senior Director of Statistical Programming. In this role, you will be responsible for study-specific statistical programming activities, maintaining programming infrastructure, and ensuring compliance with SOPs to deliver high-quality, timely outputs. Your Role: * Lead the statistical programming activities for clinical trials and studies, ensuring high-quality and timely deliverables for CSR, publications, presentations, various reports for health authority submissions, clinical data review, and ad hoc analysis * Develop, validate, and maintain analysis datasets (SDTM, ADaM), tables, listings, and figures (TLFs), in accordance with regulatory guidelines and internal standards * Review key clinical study or program documents * Perform complex statistical analyses and simulations using SAS or R to support clinical trial design and data interpretation; manage macro library and templates for efficiently preparing, processing, analyzing clinical data and validating analysis results * Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD) * Collaborate with biostatisticians, data managers, and cross-functional team members to define programming strategies and requirements, establish project timelines, and perform statistical analyses * Author or review SDTM and ADaM specifications to ensure compliant to CDISC standards * Develop SAS or R code, manage macro or utilities library and templates for efficiently preparing, processing, analyzing clinical data, and validating analysis results * Author and review statistical analysis related SOPs * Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis * Additional duties and responsibilities as required What You Bring: * Bachelor's or master's degree in statistics, life sciences, computer science, or related field with at least 8 years' statistical programming experience * Experience in oncology preferred * Solid understanding of industry standards applicable to clinical study data and regulatory reporting requirements including eCTD and CDISC implementation * Expert level in SAS programming (Base, Macro, STAT, GRAPH, SQL) is essential; with experience delivering complex programming assignments, macros, and analyses * Experience with R is desirable * Extensive experience in clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures * Expertise in the requirements and technology to support electronic submissions * Experience with BLA, NDA/sNDA submissions to FDA/EMA preferred * Strong analytical and communication skills #LI-ONSITE 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 $157,600-$236,400 USD

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: 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.

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.

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: ***********************************************

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.

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

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 Reporting to the Vice President, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management processes across Tango's clinical trials. This will include clinical trial planning through data generation and database lock. This position will initiate best practices and lead clinical data management process flow as well as support the oversight of data management vendors, data transfers and data handling. This role is ideal for someone who thrives in a dynamic environment, excels at collaboration, and is passionate about ensuring high-quality clinical data to drive impactful decision-making. Your Role: * Lead the clinical data management partnership with CROs, ensuring seamless execution of Tango's clinical trials * Provide oversight for fully outsourced data management activities from RFP to final database lock, working closely with CROs to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools * Develop and/or author key data management documents, including database design specifications, edit checks, CRF completion guidelines, and Data Management Plans, ensuring compliance with CDASH and SDTM standards * Partner with cross-functional teams to standardize data collection and reporting processes, enhancing efficiency and data quality * Guide and monitor data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders * Provide leadership and oversight for user acceptance testing (UAT) of eCRFs and associated edit checks * Establish, review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets * Collaborate with internal and external stakeholders (CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure projects are delivered on time and within budget * Participate in study team meetings, providing updates, addressing issues, and ensuring data is effectively collected, reviewed, and analyzed What you bring: * Bachelor's degree in computer science, or a science-based subject with at least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms like Metadata Rave * 5-8 years of experience leading the data management of clinical trials, from study start up through database lock, within an industry sponsor, ideally focusing on oncology or rare diseases * Strong vendor management and oversight experience * Solid technical skills across data platforms; programming experience preferred * Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology * Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance * Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data * Experience in regulatory GCP inspections/audits preferred * Experience with Spotfire, elluminate or other data visualization software * Ability to manage multiple projects in a fast-paced environment 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 $152,000-$228,000 USD

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: ***********************************************

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: 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.

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.

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 Senior Director, Brand Lead, Nephrology will be responsible for the overall brand strategy and execution for XPHOZAH - a key product in the company's Nephrology therapeutic area. This leader will evolve the brand's vision and strategic focus, drive integrated marketing efforts, and oversee the thought leader engagement strategy, ensuring cohesive communication across healthcare professionals (HCP), patients and the broader medical community. The ideal candidate is a dynamic, strategic marketer with deep experience in biotech or specialty pharmaceuticals, a proven record of successful product leadership, and the ability to inspire and guide a cross-functional team. Responsibilities: Brand Strategy & Leadership Lead the evolution and execution of the brand vision, positioning, and market strategy for XPHOZAH Partner cross-functionally with Medical Affairs, Market Access, Sales, Commercial Operations, and Corporate Communications to align messaging, data generation, and commercialization efforts Serve as the primary brand champion, ensuring consistency across all internal and external touchpoints Oversee brand performance metrics and market insights to drive data-driven decisions and optimize ROI Oversee marketing budget, and ensure all marketing programs and campaigns support overall strategy, are executed effectively with a strong ROI, and are within budget Team Management Lead and mentor a high-performing team by setting clear goals and aligning team efforts with business objectives for the HCP Marketing, Patient Marketing, and Thought Leader Engagement functions Foster collaboration, accountability, and professional development across the team Marketing Strategy & Execution Lead development of cross-functionally aligned brand plan, and foster strategically aligned functional execution of innovative HCP and DTP tactics Partner with multi-channel marketing team to develop media / NPP strategy and initiatives, ensuring alignment between patient and HCP initiatives Drive content creation and promotional materials in compliance with regulatory and medical review processes Collaborate with analytics and insights teams to continuously evaluate campaign effectiveness and refine strategies Thought Leader & Stakeholder Engagement Build and maintain strategic relationships with key opinion leaders (KOLs), professional societies, and advocacy groups Oversee advisory boards, speaker programs and congress activities to position XPHOZAH as the therapy of choice within its category Partner with Medical Affairs to ensure a scientifically grounded and compliant approach to external engagement Cross-Functional Collaboration Serve as the bridge between commercial, clinical and medical teams, ensuring alignment on messaging, evidence generation, and product lifecycle strategy Qualifications: Bachelor's degree, advanced degree (MBA) strongly preferred, with 10+ years of progressive marketing or brand leadership experience in biotech, pharmaceutical or specialty healthcare or equivalent experience Demonstrated success leading commercial strategy for a launched or early-stage marketed product in a competitive therapeutic area Proven ability to manage and develop teams Strong understanding of regulatory and compliance frameworks governing biopharma marketing Strategic and analytical mindset with operational discipline Collaborative and influential leader who thrives in a matrix environment Entrepreneurial spirit with a bias for action and innovation High emotional intelligence and executive presence Nephrology experience, inclusive of dialysis / ESRD, strongly preferred. Digital marketing experience a plus Travel Requirements: Up to ~40% travel as required to meet business needs. The anticipated annualized base pay range for this full-time position is $257,000 - $314,000. 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.

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.