Tetraphase Pharmaceuticals jobs in Waltham, MA - 1528 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: The Senior Director of Financial Planning and Analysis (FP&A) is responsible for leading the financial strategy and analytics for Nortiva Bio, Inc. In this high-visibility, hands-on role, this individual will serve as a strategic thought partner to the executive team, shaping our financial roadmap, driving operational financial excellence, and delivering clear, data-driven insights to drive informed decisions across the organization. The Senior Director will be critical in driving financial planning, budgeting, forecasting, and analysis to support our corporate goals and objectives. Responsibilities: * Lead the FP&A function, providing strategic financial insights that drive decision-making across programs and overall business operations. * Drive all FP&A activities including budgeting/forecasting, long-range planning, scenario modeling and financial analysis for strategic initiatives * Conduct timely analysis of monthly budget-to-actuals including variance analyses, generation and reporting of results * Serve as a strategic partner to executives and cross-functional leaders, translating complex financial data into clear, actionable insights that inform high-impact decisions * Deliver dashboards, reports, and presentations that clearly communicate the story behind the numbers and support decision-making. * Prepare detailed reports and presentations for senior management and the board. * Identify financial risks and opportunities and develop strategies to mitigate risks while supporting business growth * Partner with Legal to manage the purchasing process. * Support ad-hoc strategic initiatives as capabilities are demonstrated and opportunities arise; potential initiatives include but are not limited to: business development analyses, partner support, portfolio prioritization, and financing strategies * Continuously improve of FP&A processes, with the goal of improving efficiency while maintaining flexibility to adapt to future business needs Experience & Education: * Bachelor's degree in Finance, Accounting, Business Administration, or related field; MBA or relevant advanced degree preferred. * 10 plus years of experience in financial planning and analysis, with significant experience in the biotechnology or pharmaceutical industry Skills and Abilities: * Proven track record of strategic financial leadership and a deep understanding of clinical-stage operations, R&D budgeting and resource allocation * Experience supporting R&D functions and/or programs in a cross-functional environment * Proficiency with Excel in order to conduct complex analysis that will support key decisions * Knowledge of fundamental accounting principles * Strong analytical and financial modeling skills, with the ability to translate complex data into actionable business insights. * Excellent communication and presentation skills, with a demonstrated ability to influence stakeholders and and convey financial information clearly across all levels of the organization * Proficiency in financial planning tools and ERP systems; experience with business intelligence software is a plus. 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. Please Note: Innoviva Specialty Therapeutics does not accept unsolicited resumes or candidate submissions from staffing agencies or recruiters. Any such submissions will be considered property of Innoviva Specialty Therapeutics, and we will not be obligated to pay any fees associated with them unless a prior written agreement is in place.

**Join a Legacy of Innovation 125 Years and Counting!**Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: ME, NH, VT, NY, CT, RI, MA **Responsibilities:**Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: * Presenting disease state and Daiichi Sankyo product specific data to HCPs* Responding to unsolicited requests for medical information* Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards* Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making* Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders* Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships* Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies* Completes administrative duties, including monthly expense reporting and field activity reporting* Represents the Medical Science Liaison function by participating in DSI meetings, functions, events**Additional duties and responsibilities are based on position level/title, and may include but are not limited to:*** Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives.* Ability to anticipate trends and capitalize on opportunities* Lead special projects/initiatives.* Assist in the development of team members* Represent FMA leadership at DSI meetings, functions and events**Qualifications:** Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.***Education Qualifications (from an accredited college or university):**** PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred***Experience Qualifications:*****MSL/Sr. MSL*** 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred* Previous experience in Oncology, clinical research and medical education preferred**Principal MSL/Associate Director MSL*** 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred* Previous experience in Oncology, clinical research and medical education preferred***Additional Qualifications:**** Must have a valid driver's license with a driving record that meets company requirements* Ability to travel up to 60%**Compensation and seniority level/title based on experience and qualifications.** *Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.***Salary Range:**$150,800.00 - $226,200.00**Job Summary:**At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc. #J-18808-Ljbffr

The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework. You will be responsible for: Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following: Proven skill set for strategic leadership in a cross functional matrix Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications Co-lead activities related to new drug applications and other regulatory filings Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation Leading activities to identify and address process gaps Responsible for vendor management and training including budgets Responsible for overall project distribution across therapeutic area As needed represent GPS in global program teams and associated cross functional teams and/or projects Proactively provide guidance and educational training to GPS therapeutic teams Participate in ongoing safety data review and analysis for products in designated therapeutic areas. Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors. Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products. You will have: Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry Knowledge and understanding of US and EU safety regulations pre- and post- marketing Experience with Risk Management and Minimization programs Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans Experience with clinical development including risk/benefit analysis and safety assessment Strong clinical, analytical, problem solving and scientific writing and communication skills We would prefer you have: Expertise with clinical and safety databases Experience in MedDRA coding and search strategies Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Mastery of Microsoft Word, PowerPoint and Excel The annual base pay for this position ranges from $175,000 to $263,000. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 02-Dec-2025 Closing Date 16-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr

A global pharmaceutical company is seeking a Medical Science Liaison to build relationships with healthcare professionals and provide scientific support in Massachusetts. This role requires a PharmD, MD, or equivalent, along with 1+ years of relevant experience, preferably in oncology. Candidates must possess strong communication and relationship-building skills. Compensation ranges from $150,800 to $226,200, and a valid driver's license is required for travel. #J-18808-Ljbffr

A leading biotechnology company is seeking a Senior Director for Global Medical Affairs in Nephrology. This role involves providing medical and scientific leadership, developing medical affairs plans, and ensuring compliance with regulatory standards. A terminal scientific degree and 11 years of relevant experience are required. The position offers a salary range of $240,000 to $360,000, hybrid work arrangements, and various employee benefits including paid time off and educational assistance. #J-18808-Ljbffr

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Summary: The Associate Vice President (AVP), Women's Health & Early Clinical Development, serves as a pivotal leader responsible for establishing and advancing Lilly's Women's Health portfolio. We are looking for a dynamic and strategic leader with deep understanding of women's health physiology, pathophysiology and clinical care, and a passion for developing new medicines to advance women's health. The ideal candidate will have a track record of impactful translational and/or clinical research related to women's health, and a demonstrated ability to progress new medicines as part of a drug development team. Responsibilities of the role include directing research and clinical development programs through Phase 2, liaising with drug discovery scientists, external innovation, late phase development and commercial colleagues to evaluate and progress new therapeutic opportunities, and advancing external collaborations and strategic partnerships to drive impactful outcomes for women's health. The AVP will shape and execute strategies for both internal and external portfolio growth, and will collaborate closely with enterprise leaders to align scientific research and development with overarching company objectives. We are seeking a candidate with an MD or MD/PhD in gynecology or reproductive endocrinology, who specializes in the health of the female reproductive system and has provided comprehensive care for conditions including menstrual disorders, preeclampsia, infertility, menopause, and osteoporosis. Experience as a clinical researcher in academia or expertise in pharmaceutical drug development is essential. Position Responsibilities: Portfolio Strategy and Clinical Planning Shape Lilly's strategy in Women's Health by combining a deep understanding of current therapeutic landscape and competitive environment with evaluation of internal and external opportunities to build an industry-leading portfolio. Develop project concepts, investment strategies and clinical development plans that allow for efficient assessment of new therapeutic approaches and targets Collaborate with new product planning to develop and maintain Draft Launch Labels and Value Propositions that address key customer needs Contribute to and lead innovative drug discovery and development projects Serve as medical expert in interactions with external partners and during assessment of business development opportunities Clinical Research, Trial Execution and Support Collaborate with clinical research staff in design, conduct and reporting of clinical trials Review and approve risk profiles to ensure appropriate communication to study subjects Assist in planning and participate in study start‑up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Participate in investigator identification and selection Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct consistent with Good Clinical Practices and local laws and requirements. Serve as resource to clinical operations personnel / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow‑up of adverse events Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards. Regulatory Support Activities Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory response, from a global perspective. Provide medical expertise to regulatory scientists. Participate in face‑to‑face meetings with FDA, EMEA and other regulatory bodies Participate in risk management planning along with affiliates and Global Patient Safety. Data Dissemination and Scientific Exchange Participate in data analysis and preparation of final reports and publications. Prepare or review scientific information in response to internal or external questions. Participate in and lead scientific disclosures and publications. Support and lead the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and international basis. Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical practice guidelines relevant to women's health are discussed Develop and maintain appropriate collaborations and relationships with relevant professional societies. Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Scientific / Technical Expertise and People Development Maintain and disseminate within Lilly information on latest developments in the pathophysiology, diagnosis, etiology, treatment and management of women's health. Critically read and evaluate the relevant medical literature. Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the priority areas Actively set and meet individual professional development goals Contribute to the development of others by acting as mentor and coach to co-workers Basic Qualifications: MD or MD/PhD. Must be board eligible or certified as gynecologist or reproductive endocrinologist or have completed the comparable level of post‑medical school clinical training relevant to the country of hiring. Clinical trialist with a track record of developing clinical plans and execution of studies in the pharmaceutical industry Minimum of five years experience in clinical research/drug development in academia or industry including the design and implementation of large global clinical trials. Minimum of five years experience in clinical practice with at least 2 years in Women's health. Qualified candidates must be legally authorized to be employed in the United States. Additional Skills/Preferences: Team‑player with proven ability to shape project direction and influence stakeholders Demonstrated ability to drive for results in a fast‑paced matrixed environment Innovation mindset with a passion for novel therapies Strong business acumen and strategic planning and execution skills Excellent written and verbal communication skills Physical Demands/ Travel: The physical demands of this job are consistent with light office duties. Up to 20% US/Global travel. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ******************************************************* for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. $291,000 - $453,200 Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day‑care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly #J-18808-Ljbffr

A leading biotechnology company in Boston is seeking an Associate Director, GMP Operational Quality to ensure compliance and quality oversight for commercial drug manufacturing. The role includes managing relationships with vendors, mentoring team members, and leading quality improvement initiatives. Candidates should possess strong knowledge of cGMPs, a scientific degree, and extensive experience in quality assurance and project management. This position offers a hybrid work model and competitive compensation package. #J-18808-Ljbffr

A global healthcare leader seeks a scientific leader to manage a team in gene therapy research. The role includes leading AAV vector production projects, driving innovation, and developing talent within the team. Ideal candidates should have a PhD in a relevant field and 7 to 10 years of industry experience. This position is based in Boston, Massachusetts, with a compensation range of $158,250 to $275,000 and a comprehensive benefits package. #J-18808-Ljbffr

At Nia Therapeutics, we are engineering solutions at the frontier of neuroscience to make memory loss reversible. We are a team of scientists and engineers developing advanced implantable brain stimulation devices to reverse memory loss from brain injury and degenerative disease. Our core technology, developed at the University of Pennsylvania and funded by DARPA, is built on a foundation of human clinical studies that demonstrate its efficacy. This is a rare opportunity to help develop a product that will not only improve patient lives but also redefine what's possible in neural engineering. WHAT YOU WILL DO Develop embedded firmware in C to support BLE communication between an implantable device and mobile apps Design and implement custom GATT services and characteristics to enable secure, low-latency data exchange Support real-time signal processing, sensor interfaces, and closed-loop control logic Contribute to the design of system-level communication protocols across implant, wearable, and cloud platforms Help build automated test systems for wireless and embedded functionality REQUIRED QUALIFICATIONS BS in Electrical Engineering / Computer Science plus 5+ / 8+ / 11+ years experience OR an advanced degree plus 3+ / 6+ / 9+ years of experience Strong programming skills in C for embedded systems Hands‑on experience developing and debugging BLE firmware, including custom profiles and characteristics Understanding of BLE stack behavior (advertising, connection parameters, bonding, encryption) Comfortable working with microcontroller toolchains, oscilloscopes, and logic analyzers Ability to read datasheets and electrical schematics and develop device drivers Strong troubleshooting, communication, and cross‑functional collaboration skills PREFERRED SKILLS Experience with ST or Nordic microcontrollers RTOS based firmware development (e.g. FreeRTOS, Zephyr) Hands‑on experience developing and debugging Bluetooth Low Energy (BLE) communication protocols, including creating custom GATT services and characteristics Experience integrating mobile applications with embedded firmware, ensuring robust and reliable data exchange Experience developing active implantable medical devices, medical device quality systems, standards (e.g. ISO-14708) and risk management activities (e.g. FMEA) Proficiency in cross‑platform (Android, iOS) mobile application development Broad circuit design experience including analog, digital, power supply and comms functions Setting up and maintaining testing environments for hardware and software systems OUR CULTURE This position is 5 days per week in person based in Boston, MA. We're a small team tackling big challenges. We move quickly, think rigorously, and care deeply about the impact of our work. If you're excited by the idea of helping build a product that integrates neuroscience, embedded systems, and mobile UX, and you're eager to grow in a fast‑paced startup, we'd love to meet you. BENEFITS Nia Therapeutics provides comprehensive health benefits to support our employees' well‑being, including medical, dental, and vision insurance. We also offer stock options, giving team members a direct stake in the company's success and long‑term mission. #J-18808-Ljbffr

Project Management & Strategic Operations Director page is loaded## Project Management & Strategic Operations Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27588**Job Description****General Summary:**The Project Management & Strategic Operations Director - Clinical Development serves as the end-to-end program lead for large-scale strategic programs of high business value. Drives benefit achievement by leading program initiation, planning, solution design and build, and by measuring key performance indicators and solution adoption. Engages other colleagues/resources and assigns appropriate responsibilities to support achievement of program roadmap and project plan(s). Independently applies expert knowledge of advanced methodologies, selecting and applying high-level project management tools to conduct analyses, reporting and related activities for assigned projects. Contributes to the development of internal protocols and processes used to carry out program management work. Responsible for program management activities including contingency/dependency tracking, status reporting, issue/risk identification and tracking, scope management, estimation, and internal/external stakeholder management. Provides oversight to workstream/task leads within the program; resolves any escalated project risks, issues and dependencies. Manages the overall scope and timing of the program, ensuring on-time and within budget delivery.This role will serve an important role in the Global Clinical Development organization to improve focus and alignment across programs and ensure greater organizational effectiveness. Responsibilities will include working with other functions within Vertex to obtain accurate, up-to-date plans and metrics across all clinical development programs to ensure visibility and alignment, including study milestones, enrollment metrics and budgets.**Key Duties and Responsibilities:*** Organizing, driving and managing the Clinical Development deliverables in terms of timelines, budget and communication.* Serve as a strategic partner to the SVP, Clinical Development; create and run reports, create presentations, draft communications documents, serve on cross-functional strategic initiatives representing Clinical Development.* Support the SVP, Clinical Development in creating, communicating and tracking annual goals* Partner with Clinical Development Execution group to use the clinical operations systems to track study enrollment across programs vs target and translate the information to make it relevant and user friendly for Clinical Development.* Work with finance, clinical development execution team and medical directors to track study budgets across programs vs target* Collaborate with regulatory team to use the regulatory systems to track upcoming regulatory meetings and briefing documents (drafts/review schedule etc) and translate to make this information to make it relevant and user friendly for Clinical Development* Run the TA review meetings including meeting minutes, tracking and archiving submissions and decisions* Drive executional excellence in terms of timelines, sign-offs, submissions to internal governance (eg protocols, CSRs, etc) and external postings like clinical trials.org* Support onboarding, compliance/SOP training and tracking, team effectiveness* Lead communications within the Clinical Development team including updates within the team, to cross-functional partners including those ex-US, and bring relevant communications from the broader organization in to ensure the Development area are aware and prepared* Oversees end-to-end program management activities for large-scale, strategic programs of high business value, with oversight for the full project lifecycle* Manages the progress and contributions of workstream leads or subordinate project managers to ensure all activities deliver expected value within committed timeframes and budget* Manages contingencies between multiples projects and monitors interdependencies and synergies where required* Builds and synthesizes highly-detailed project plans, budgeting & forecasting models or resource plans, requiring significant stakeholder management skills and interpretation of diverse and varied information* Develops statements of work, stakeholder management plans, guiding principles, project goals, risks, resource allocation, and roles and responsibilities for assigned projects* Secures, leads, motivates and inspires the internal and external resources required to effectively deliver the program. Establishes the program's governance (e.g., sponsors, approvers, stakeholders)* Participates in the evaluation, selection and management of external resources or vendors* Provides transparency in project progress and effectively anticipates and mitigates major risks across the project lifecycle* Proactively crafts feasible solutions to combat risks and issues. Exercises sound judgement balancing risks and making prompt decisions in ambiguous or difficult situations* Manages communication with management at a detailed functional level and discusses/resolves issues* Works with all required functions and groups to effectively plan and execute the program/project(s). May coordinate resources across organizational boundaries* Trains and coaches project teams in execution methodologies and promotes adoption of best practices* Develops tools and training methods to enable successful project management throughout the enterprise. Ensures project delivery is in conformance with company methodologies and standards; recommends improvements and changes as necessary* Evaluates program costs and benefits including actual results and forecasts with comparisons to original or baseline plan and updates plans with accurate, up-to-date information in a timely manner. Reports financial information and status to leadership. Ensures program solution(s) meets quality and reliability requirements and that the launch approach meets or exceeds adoption targets. Monitors program results/performance for significant deviations, evaluates options and makes recommendations for corrective actions, and then implements selected actions**Knowledge and Skills:*** Some education, training or experience in biology/chemistry/engineering desirable* Drug Development knowledge and/or project management experience preferred* Proven experience in cross-functional execution including medium to large-scale projects* Critical thought partner and proven ability to connect people and ideas to drive outcomes* Demonstrated ability to connect with over divisions and functions throughout Vertex* Ability to manage multiple priorities/projects at a given time, ensuring deadlines, budgets and status updates* Highly developed communication skills and the ability to synthesize data and information into meaningful insights* Very detail oriented and strong project/operation management skills* Ability to handle ambiguity**Education and Experience:*** Bachelor's degree* Typically requires 10 years of experience or the equivalent combination of education and experience**Pay Range:**$183,800 - $275,700**Disclosure 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. #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

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, 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

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 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

A global biotechnology company is seeking a Director of Downstream Process Development in Boston. This role requires advanced leadership skills and expertise in biologics, overseeing the development and optimization of therapeutic biologics with responsibilities in both technical and regulatory aspects. Candidates should have extensive experience with chromatography systems and drug substance development, ensuring compliance with quality standards. Competitive salary range is $195,500 - $293,200, and this is an on-site position. #J-18808-Ljbffr

A global healthcare leader is seeking an experienced Associate Director in External Partnering to drive portfolio growth in molecule discovery and technology licensing. This strategic role involves expanding client relationships within the U.S. biotechnology sector. The ideal candidate will have a strong background in drug discovery and sales expertise. Key responsibilities include identifying new business opportunities and collaborating with scientific teams to develop optimized solutions. The position may allow for remote options and requires up to 30% travel. #J-18808-Ljbffr

Senior Medical Science Liaison - Nephrology (Missouri/Iowa/Nebraska/ Illinois: South/Central) page is loaded## Senior Medical Science Liaison - Nephrology (Missouri/Iowa/Nebraska/ Illinois: South/Central)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-26673**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

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.