Tetraphase Pharmaceuticals jobs in Waltham, MA - 1463 jobs

Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. The company's proprietary LYNX drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near-term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes. Summary of Position: Nortiva Bio, Inc. is seeking an experienced Test Engineer to drive characterization of novel long-acting oral drug products. Nortiva's ultra-long-acting oral drug delivery platform uniquely combines elements of controlled drug delivery, traditional and non-traditional formulation components and processes, and dynamic structural features required for gastric residence. In this role, you will be responsible for developing and executing laboratory methods to assess physical properties of Nortiva's long-acting oral products, ensuring phase-appropriate methods and specifications are in place to assess Critical Quality Attributes (CQAs) for clinical trial material. The ideal candidate brings experience in mechanical characterization of polymeric materials in biological environments as well as experience in mechanical test development, validation, and verification for medical devices. Strong skills in innovation, attention to detail, clear communication/documentation, and team collaboration are essential. This role is primarily onsite in Lexington, MA. Responsibilities: * Drive strategic development, validation, and execution of novel in vitro/mechanical test methods to predict in vivo performance for the drug delivery platform technology * Develop phase-appropriate methods and specifications for critical physical attributes of the product, validate methods, support batch release and stability * Ensure execution of all development and routine testing, analyze results, and correlate to in vivo data * Lead/support mechanical design of test method fixturing and equipment * Work collaboratively with formulation, engineering, and project management functions to meet timelines and prioritize efforts * Clearly align and communicate key outputs/learnings from test method development efforts and ensure knowledge is shared cross-functionally * Author and/or review CMC sections of regulatory documents and submissions Experience & Education: * BS Degree in Mechanical Engineering, Chemical Engineering, Bioengineering, Materials Science, or related field is required; an advanced degree (MS, PhD, PharmD) is preferred * 3+ years of experience in mechanical test method development and validation for drug delivery technologies, combination products, or medical implants * Experience with testing plastic materials that are implanted or ingested preferred * Knowledgeable of the fundamentals of polymer chemistry, material properties, and composites Skills and Abilities: * Strong data analysis skills, including design of experiments and/or statistical modeling using software such as JMP * Familiar with mechanical design of fixturing and/or tooling, computer-aided design (CAD) software programs, and 3D printing technology * Excellent analytical and problem-solving skills; fast learner with the ability to adapt to changing priorities and thrive in a fast-paced environment * Eagerness to support teammates across functions, providing hands-on support for testing and manufacturing as needed The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Nortiva Bio, Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

A global biopharmaceutical company is seeking a Global Head of Research and Biomarkers in Waltham, MA. This executive role involves leading R&D for mRNA and LNP, strategizing biomarker optimization, and managing teams of scientists. Ideal candidates will have a PhD and over 15 years of experience in the biotech industry, alongside skills in molecular biology and team leadership. This is an opportunity to advance next-gen scientific innovations in vaccines. #J-18808-Ljbffr

A leading biopharmaceutical company in Massachusetts seeks a Senior Director of Biostatistics to oversee statistical contributions for clinical development in Cardio and Renal therapeutic areas. This role involves leading a team of statisticians, providing statistical thought leadership, and ensuring excellence in clinical trial design and regulatory submissions. Candidates should have a PhD in statistics and over 10 years of industry experience. This position offers the chance to contribute to innovative therapies and make a meaningful difference in patients' lives. #J-18808-Ljbffr

A leading biotechnology company is seeking an Associate Director, Global Pain Market Research to join its Boston team. In this role, you will oversee commercial insights supporting the Global Commercial Strategy for pain management. Key responsibilities include designing primary market research and developing the annual situation analysis. Candidates should have a Bachelor's degree and 8+ years of relevant experience in market research and bio-pharma marketing. Flexible work options are available. #J-18808-Ljbffr

A leading pharmaceutical company is seeking a Director, Safety Scientist in Boston. This role involves leading risk management for key projects, mentoring safety scientists, and ensuring compliance with regulatory standards. The ideal candidate has advanced degrees and extensive experience in drug safety. This position offers a competitive salary range of $175,000 to $263,000 along with various benefits and incentives. #J-18808-Ljbffr

A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits. #J-18808-Ljbffr

A pioneering neuroscience company based in Boston, MA is seeking a firmware developer to create embedded solutions for advanced brain stimulation devices. The ideal candidate will have a strong background in C programming, experience with BLE protocols, and a passion for building innovative healthcare technologies. The role offers comprehensive benefits, including health insurance and stock options. #J-18808-Ljbffr

The role will be responsible for all operations involved with routine manufacturing and quality control testing of radiopharmaceuticals produced in Aktis' GMP laboratory (Boston, MA), including but not limited to the list below. This role will report to the Director of Clinical Trial Manufacturing. Salary Range: $136,800.00 To $189,200.00 Annually Responsibilities Manual and automated production of radiopharmaceuticals in a GMP facility QC testing of radiopharmaceuticals Execution and upkeep of the facilities' environmental monitoring program Accurate and timely preparation and completion of manufacturing and Quality control records (Batch Records, Forms, Logbooks, etc.) Process/analytical method validation for clinical manufacturing Operation and maintenance of equipment in the GMP facility Preparation of products for shipment to other sites Drafting, reviewing and updating GMP documentation including SOPs Upkeep and maintenance of inventory in the GMP Facility Maintenance of the GMP facility including assisting with radioactive waste stream management Perform contamination wipe tests and surveys Performing and maintenance of the facilities' environmental monitoring program Leading manufacturing process and analytical method qualification activities Contribute to writing CMC sections for submission to regulatory agencies Maintain KPI and internal reports Supporting external tech transfer activities Required Skills Proficient with aseptic operations and environmental monitoring Proficient with QC methodologies (HPLC, GC, MS, Gamma Spec, etc.) Proficient with assembly and interpretation of analytical data Expertise with troubleshooting analytical and production equipment High attention to detail and organizational skills to enable working in a fast-paced environment Ability to work in an ISO7 environment with full gowning Adhere to stringent cleanroom protocols and maintain a high level of hygiene Perform precise aseptic manipulations in a restrictive environment Awareness of FDA and EU GMP requirements Ability to lift 60lbs Expertise with GMP radiopharmaceutical manufacturing and quality control Minimum, B.Sc. with 10+ years or M.Sc. with 7+ years of experience in the pharma industry or equivalent research experience Comprehensive knowledge of GMP manufacturing and quality control workflows Excellent verbal, written, and organizational skills Strong desire to be part of a mission‐oriented company leading transformative change for patients Proven demonstration of transparent communication and fostering open and diverse debate Ability to work with agility and manage ambiguity Personifies positive energy and exemplifies respect #J-18808-Ljbffr

A global biotechnology company is seeking a Policy & Alliance Development Director to build policy initiatives and strategic alliances focusing on kidney disease. The role involves developing reimbursement strategies and managing partnerships with patient organizations. Ideal candidates will have extensive experience in public policy, government affairs, and a Bachelor's degree. A hybrid work model is available, with competitive compensation between $204,600 and $307,000 annually. #J-18808-Ljbffr

The organization is seeking a mid-to-senior level Automation Engineer to support Opex and Capex projects in a pharmaceutical manufacturing facility. This role focuses on the commissioning, qualification, and optimization of automated process equipment and control systems. The position requires experience with plant automation systems (Rockwell PlantPAx preferred) and involves designing validation protocols, troubleshooting controls, and implementing reliable, efficient automation solutions. Responsibilities: Automation Execution & Documentation: Independently develop, configure, and test automated systems and control equipment, including PLCs, HMIs, and plant-wide automation networks. Analyze system performance, generate technical reports, and ensure all documentation meets cGMP, GDP, and regulatory standards. Project Planning & Scheduling: Proactively plan and manage automation commissioning and integration activities. Provide input on project timelines and ensure alignment with overall facility schedules for both CapEx and OpEx initiatives. Cross-Functional Collaboration: Serve as the automation representative on project teams, coordinating with Engineering, QA, Operations, and Validation teams to deliver robust, compliant, and reliable automation solutions on schedule. Technical Interpretation & Testing Strategy: Review and interpret technical documentation (e.g., URS, FS, P&IDs, SOPs) to develop system architecture and testing strategies. Translate specifications into functional test cases and ensure all automation requirements are fully verified and documented. Communication & Troubleshooting: Provide clear and timely updates on automation status, risks, and corrective actions. Independently troubleshoot system issues during commissioning and operational phases, implement solutions, and maintain optimized and compliant automated systems. Preferred Experience Hands-on experience with automation commissioning and qualification, including operation of automated manufacturing equipment (Rockwell PlantPAx preferred). Experience performing chamber temperature mapping, worst-case load justification, and periodic requalification reviews to confirm the validated state. Experience with cleaning cycle development, rinse sampling, surface swabbing, and visual inspections to support cleaning validation or verification. Prior qualification/testing experience with process equipment (e.g., synthesizers, UF, HPLC, lyophilizers, CIP, WFI, clean utilities, cleanrooms) and systems using Unicorn software. Experience with electronic validation management systems (e.g., Veeva, Kneat, ValGenesis) and familiarity with PLC code/ladder logic to support testing and regression analysis. Requirements Must be able to meet on-site work requirements in Norton, MA. Bachelor's degree in a STEM field (Biomedical, Chemical, Electrical, or Mechanical Engineering preferred) or equivalent experience. 5+ years of hands-on experience in automation commissioning, control system implementation, and process equipment integration in a GMP biotech or pharmaceutical manufacturing environment. Proven ability to manage, prioritize, and execute multiple automation projects simultaneously, ensuring on-time delivery and compliance. Strong proficiency in Good Documentation Practices and regulatory compliance within automated system development and operation. Willingness to work on-site outside standard business hours as needed to support system commissioning, troubleshooting, and optimization activities.

Title: Associate Director of Regulatory Strategy A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development. Key Responsibilities Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning. Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters. Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor. Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements. Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities. Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation. Qualifications Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development. Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies). Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA). Familiarity with 505(b)(2) development strategies or innovative delivery platforms. Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas. Proven track record of successful interactions with the FDA and/or global regulatory agencies. Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies. Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.

Senior Medical Science Liaison - Nephrology (Michigan: East) page is loaded## Senior Medical Science Liaison - Nephrology (Michigan: East)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-26679**Job Description****General Summary:**The Senior Medical Science Liaison (Sr MSL) (Nephrology) for Povetacicept programs. Povetacicept (pove) is an enhanced, dual BAFF/APRIL inhibitor in pivotal development for the treatment of IgA Nephropathy (IgAN).The Sr MSL will serve as a scientific liaison to the medical/academic community and is responsible for establishing and maintaining relationships with Health Care Providers/Professionals (HCPs) to ensure the appropriate dissemination of clinical and scientific information regarding Vertex' compounds in a timely, ethical and stakeholder-focused manner. The Sr MSL will contribute to shaping the medical plan by providing external stakeholders' insights and contribute to the designing and execution of the Medical Affairs strategy and plan. The Sr MSL will engage HCPs in response to scientific educational and research needs with available Vertex resources and provide the latest emerging data in response to specific inquiries, as appropriate.**Key Duties and Responsibilities:*** Develops and fosters effective and trusting relationships with Thought Leaders (TL) and identifies and engages other appropriate HCPs resulting in scientific engagement with a large network of T1D and transplant-team care providers and opinion leaders. Additionally, understands the inter-relationships both within and between academic centers and utilizes this expertise to enhance Thought Leader and HCP engagements* Consistently incorporates all aspects of the SEM (Scientific Engagement Model) into all interactions, enhancing the quality of interactions and overall relationships as assessed by field coaching observations* Independently incorporates the medical plan into interactions and territory planning (i.e. listening priorities) and captures valuable feedback in the CRM system to inform internal stakeholders and assist in shaping the medical strategy* Possesses an in-depth understanding of the utility and functionality of the CRM system/data analytics tools, allowing for the time sensitive capture of interaction details. Uses CRM/Analytics to enhance future TL engagements and manage workload* Discusses scientific information effectively and compliantly with external stakeholders at an advanced level of communication for both disease state and product to external stakeholders as assessed by management coaching and field observations* In-depth conceptual and practical knowledge of payers in the region and possesses an in-depth understanding of the impact of payers on patient care delivery* Assists clinical development/clinical operations by fully understanding IB content and presenting IB material, providing nominations for trial sites as requested, providing end of study data reviews with investigators (as needed)* Represents Vertex at medical congresses by providing scientific session/abstract coverage, booth staffing coverage, routine TL interactions, contributing to the daily and end of congress summaries and may provide logistical guidance through organizing and scheduling abstract/session coverage and preparing and delivering the conference debrief (as needed)* May serve as a mentor or trainer for colleagues with less experience; for example, assisting with new hire MSL onboarding* Conducts all activities in compliance with Vertex policy and procedures and performs all administrative tasks in a timely manner such as CRM entry, vehicle mileage reporting, expense reporting, calendar entries, training assignments, etc.**Knowledge and Skills:*** Ability to complete goals within allotted timeframes, and deliver high quality results* Ability to help plan and complete projects in a constantly changing field-based environment* Ability to appraise and comprehend medical and scientific literature* Ability to effectively present clinical/scientific information in a credible manner in varied settings* Good knowledge of assigned geographic territory* In-depth understanding of healthcare regulatory environment* Apply proficient knowledge of relevant T1D and T1D management protocols, healthcare environment and landscape to articulate the medical and scientific value of our products* Demonstrated working understanding around the compliance and regulatory frameworks that govern the pharmaceutical industry and conducts compliant interactions with internal and external stakeholders.* In-depth knowledge of payers and unique medical information needs to support access and appropriate use of Vertex medicines* Good knowledge of Health Economics and Outcomes Research* Fluent in English (oral and written)**Education and Experience:*** Minimum requirement for advanced biomedical or life sciences degree (ex. Masters, NP, PA)* Requires minimum of 3-4 years of experience as an MSL supporting Nephrology programs or in other medical affairs roles in the pharma/biotech industry or the equivalent combination of education and experience.* Previous training or experience in designated therapeutic area is helpful Pay Range:$171,300 - $245,000Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. #J-18808-Ljbffr

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

A global biotechnology company is seeking a Senior Manager for their Order to Cash function to drive cash flow optimization and manage credit control. This role requires excellent stakeholder management and financial analysis skills. The successful candidate will work closely with various teams, present updates to senior leadership, and have opportunities for personal development in a hybrid-eligible environment. Experience in pharmaceutical or large organizations is preferred. #J-18808-Ljbffr

A leading biotechnology company is seeking a Director, Global Process Excellence to enhance finance systems and processes integral to scaling operations. This role requires extensive finance experience, capability in project management, and leading cross-functional improvements. The position offers a hybrid work model and competitive salary range of $180,800 - $271,100, along with generous benefits and annual bonus eligibility. #J-18808-Ljbffr

A leading biotechnology company in Boston seeks a Senior Director of Global Development FP&A to spearhead financial planning and analysis for clinical trials. The ideal candidate has deep expertise in clinical trial finance, project management, and cross-functional collaboration. Responsibilities include managing complex budgets and providing strategic insights to senior leadership. This hybrid-eligible role offers a competitive salary and benefits package. #J-18808-Ljbffr

Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. The company's proprietary LYNX drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near-term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes. Summary of Position: Nortiva Bio, Inc. is seeking an experienced Test Engineer to drive characterization of novel long-acting oral drug products. Nortiva's ultra-long-acting oral drug delivery platform uniquely combines elements of controlled drug delivery, traditional and non-traditional formulation components and processes, and dynamic structural features required for gastric residence. In this role, you will be responsible for developing and executing laboratory methods to assess physical properties of Nortiva's long-acting oral products, ensuring phase-appropriate methods and specifications are in place to assess Critical Quality Attributes (CQAs) for clinical trial material. The ideal candidate brings experience in mechanical characterization of polymeric materials in biological environments as well as experience in mechanical test development, validation, and verification for medical devices. Strong skills in innovation, attention to detail, clear communication/documentation, and team collaboration are essential. This role is primarily onsite in Lexington, MA. Responsibilities: Drive strategic development, validation, and execution of novel in vitro/mechanical test methods to predict in vivo performance for the drug delivery platform technology * Develop phase-appropriate methods and specifications for critical physical attributes of the product, validate methods, support batch release and stability * Ensure execution of all development and routine testing, analyze results, and correlate to in vivo data * Lead/support mechanical design of test method fixturing and equipment * Work collaboratively with formulation, engineering, and project management functions to meet timelines and prioritize efforts * Clearly align and communicate key outputs/learnings from test method development efforts and ensure knowledge is shared cross-functionally * Author and/or review CMC sections of regulatory documents and submissions Experience & Education: * BS Degree in Mechanical Engineering, Chemical Engineering, Bioengineering, Materials Science, or related field is required; an advanced degree (MS, PhD, PharmD) is preferred * 3+ years of experience in mechanical test method development and validation for drug delivery technologies, combination products, or medical implants * Experience with testing plastic materials that are implanted or ingested preferred * Knowledgeable of the fundamentals of polymer chemistry, material properties, and composites Skills and Abilities: * Strong data analysis skills, including design of experiments and/or statistical modeling using software such as JMP * Familiar with mechanical design of fixturing and/or tooling, computer-aided design (CAD) software programs, and 3D printing technology * Excellent analytical and problem-solving skills; fast learner with the ability to adapt to changing priorities and thrive in a fast-paced environment * Eagerness to support teammates across functions, providing hands-on support for testing and manufacturing as needed The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Nortiva Bio, Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness Ensure the TMF complies with all applicable regulatory requirements and guidelines. Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications Bachelor's Degree Required. 3+ years of hands-on Veeva Vault eTMF experience required. 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). Experience in managing TMF documents during audits or regulatory inspections. Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. Basic understanding of study and site management and overall trial planning and execution. Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. Strong work ethic, organizational skills, oral and written communication skills, a ‘can do' approach, problem-solving skills, and team player skills. Ability to multi-task and manage several projects in parallel while paying attention to detail. Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

A leading biotechnology company is seeking a Director of Digital Marketing to drive engagement for their kidney portfolio. You will develop omnichannel strategies, collaborate across teams, and leverage data insights to enhance brand impact. Ideal candidates will have over 10 years in pharmaceutical marketing and proven success in digital campaigns. This position offers a hybrid work option and competitive compensation according to skills and experience, along with extensive benefits. #J-18808-Ljbffr