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· Licensed to practice professional nursing as a registered nurse (RN) in the Commonwealth of Massachusetts. Previous experience with grant writing, IRB submissions, data management, study coordination and database development, preferred.. The Clinical Research Nurse II (CRN II) will report directly to the Medical Director (MD) of the Cancer Clinical Trials Program and the Administrative Director in Hematology and Medical Oncology.. Will see patients during required study visits and, partnering with the clinical research coordinator, ensure compliance with study requirements.. The Clinical Research Nurse will also provide clinical perspective and information to regulatory coordinators as needed to facilitate trial activation.
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts.. The Associate Director, Clinical Quality Assurance (CQA), will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Centessa sponsored clinical trials (Early-Late Phase) with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Centessa Standard Operating Procedures (SOPs), and current industry standards and practices.. Support GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.. Provide Clinical QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested.. Proficiency in using Veeva and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint).
GSK is seeking a dynamic and experienced Executive Medical Director, Clinical Research for Hepatology Clinical Trials to lead our clinical development programs within the hepatology therapeutic area.. This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK's UK (London - New Oxford Street or Stevenage) or US(PA or MA) sites.. Oversee the development and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and GSK's scientific standards.. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. The Executive Director will build the clinical pharmacology function to enable the design and efficient execution of all Phase 1 programs across multiple therapeutic areas including epilepsy, psychiatry, and pain.. In addition, the role will require the development of strong working relationships within Clinical Development Department and with other key functions including, for example, Pharmacovigilance and Drug Safety, Regulatory, Discovery, CMC, Translational, Trial Operations, Biostatistics and Program Management.. Provide strategic and clinical pharmacology leadership to all development programs across epilepsy, psychiatry, and pain programs. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Who We Are:Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders.. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. A Bachelor's, or Master's, PharmD or PhD in a scientific, medical or regulatory discipline with a minimum of 4 years Regulatory Affairs management experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment required.. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases.. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability.. By joining our growing and dynamic regulatory affairs team, you’ll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments.. Key accountabilities include providing technical and procedural regulatory guidance and strategy to key internal stakeholders to advance the development, commercialization and life cycle of Rhythm products.. This role reports into the Director, Global Regulatory Affairs.
Key areas of focus include vendor management, cross-functional collaboration, and driving the in vivo and in vitro strategy across the pipeline.. Identify and implement preclinical models that reflect patient pathology; develop assays to support in vitro and in vivo assessments of efficacy or relevant biomarker activity.. Lead and oversee in vivo preclinical safety, PK/PD, and potential efficacy studies.. Define preliminary dosage and dosing regimens based on in vitro and in vivo data; partner with CMC and device teams to ensure feasible delivery approaches.. Ph. D. in Pharmacology, Pharmacokinetics, Biology, or related scientific fields.
This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Marlborough, MA, or Arden Hills, Maple Grove or Minnetonka, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.. Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and MDR CE mark submissions. Prior experience with a variety of submission types (DeNovo, 510(k), PMA, EU MDR). Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).. Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Clinical Research Nurse Thoracic Oncology New The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area.. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care.. Collaborates with the Dana-Farber Harvard Cancer Center DFHCC quality assurance of clinical trials office in developing protocol specific materials.. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.. Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).. Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions.. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs.. Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy.
Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases.. To accelerate and expand its efforts,CRISPR Therapeuticshas established strategic partnerships with leading companies including Vertex Pharmaceuticals.. Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable.. Solid understanding of the basic principles of biochemistry and molecular biology. Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
Sr. Manager/Associate Director, Regulatory Affairs Strategy and Labeling. Building on the company's leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. Agios Pharmaceuticals is searching for a Senior Manager/Associate Director of Regulatory Affairs Strategy and Labeling to join our growing Regulatory team.. The Senior Manager/ Associate Director of Regulatory Affairs Strategy will be responsible for working cross-functionally across the organization to develop or contribute to, and execute upon regulatory strategies to support clinical development plans and to prepare and coordinate compliant, high quality, nonclinical and clinical global regulatory submissions across early development, registration, and life cycle management.. Associate Director: Must have a minimum of 6 years in Regulatory Affairs strategy and labeling combined
Title: Regulatory Affairs Associate. Reporting to: Regulatory Affairs Manager. We are seeking a highly motivated and results-driven Regulatory Affairs Associate to join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ensuring that medical devices produced by Venus Concept meet all regulatory requirements for countries where the devices are marketed.. Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 10 direct markets.. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, Venus Epileve, Venus Viva MD and AI.ME. Venus Concept's hair restoration systems include NeoGraft and the ARTAS iX Robotic Hair Restoration system.
Xenon Pharmaceuticals ( NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders.. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. Build effective partnerships with cross-functional teams (e.g., regulatory affairs, clinical development, biometrics).. Extensive experience writing regulatory submission documents across all phases of drug development (e.g., clinical protocols, Investigator’s Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs).. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
At Vertex, O ur Medical Writing Scientists are strategic partners in the drug development process, collaborating with cross functional teams to bring new, innovative, life-changing products to patients.. The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development.. This is a hybrid position which allows for 2 days per week remote work, and 3 days per week in the Boston Fan Pier office.. Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas. Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients.. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office.. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology. 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.. Vertex is a global biotechnology company that invests in scientific innovation.
PathAI is seeking a Senior Clinical Scientist to play a key role in driving our in vitro diagnostic (IVD) device projects, strategy and roadmaps.. Study Design & Documentation Develop and author clinical protocols, study reports, and regulatory submission documents in compliance with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) guidelines.. Support data review and interpretation to ensure clinical relevance and regulatory compliance.. Advanced degree (PhD, MD, PharmD, or equivalent) in a relevant scientific discipline such as biomedical sciences, pathology, or clinical research.. 3+ years of experience in clinical development, clinical trials, or regulatory affairs within diagnostics, medical devices, or biotech/pharmaceutical industries.
Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.. The Nuvalent pipeline is currently focused on development of precision medicines for oncology targets; therefore, the physician will work closely with a multi-disciplinary team consisting of non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, data management, pharmacovigilance, and regulatory affairs.. Be the clinical lead for clinical trials, including performing detailed review and evaluation of molecular pathology reports for eligibility, and ongoing monitoring of clinical and laboratory data, assessing safety, and responsibility for analysis of emerging safety and clinical signals.. Provide Pharmacovigilance support for the clinical trials in conjunction with our PV team. Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance
In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. The Vice President, Regulatory Affairs (Clinical) will establish and manage global regulatory strategy and operations for the Company's product pipeline from early and late-stage development through registration and post-approval activities.. Develop, propose and implement global regulatory strategies for development of the Company's portfolio of products and product candidates from discovery through development and commercialization in alignment with corporate strategy.. Minimum of 15 years of Regulatory leadership roles of increasing responsibility with small and large multi-national biopharma companies; neurology experience, specifically epilepsy, highly desirable.. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. Collaborates with the Dana-Farber Harvard Cancer Center DFHCC quality assurance of clinical trials office in developing protocol specific materials. Minimum of 1-year recent experience as an RN Ambulatory and/or oncology experience preferred Professional nursing certification preferred (OCN, BMTCN, CPHON, AOCNP, CRNI, RN-BC) AHA BLS required (AHA ACLS accepted as minimum requirement) At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.