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  • Principal Scientist (Residual Impurities)

    MacRogenics, Inc. 4.8company rating

    Drug safety scientist job in Rockville, MD

    Job Category: Development Apply now Posted : November 5, 2025 Full-Time On-site Headquarters 9704 Medical Center Dr Rockville, MD 20850, USA MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceuticaland biotechnologycompanies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization. Summary of Position The Principal Scientist is a technical and strategic leader responsible for method development, qualification, transfer, and lifecycle management of residual impurity assays for biopharmaceutical products including monoclonal antibodies (mAbs), bispecifics, and antibody-drug conjugates (ADCs). This individual thrives in a cross-functional, fast-paced, and collaborative environment, applying strong troubleshooting ability, scientific rigor, and a results-driven mindset to support programs from early development through commercialization. The role demands high accountability, proactive planning, and timely execution of deliverables. The Principal Scientist will supervise and mentor team members while serving as a subject matter expert in residual impurity testing across Biopharmaceutical Development (BPD) and CMC teams. Responsibilities and Job Duties: Lead the development of fit-for-purpose and robust residual impurity assays (e.g., HCP, DNA, Protein, Enzyme, Surfactant etc.) to support biologic product development and release. Provide technical leadership and hands‑on troubleshooting for analytical methods and instrumentation to resolve issues efficiently and maintain method robustness. Own and drive method lifecycle activities including development, qualification, transfer to QC, and support method validation aligned with ICH and regulatory expectations. Ensure on‑time delivery of analytical method development and testing support for process development, process characterization, analytical comparability, and CQA assessment efforts. Manage project timelines for impurity analysis and proactively communicate risks, progress, and mitigation strategies to stakeholders. Collaborate with CMC teams and Regulatory Affairs to develop residual impurity control strategies, specifications, and regulatory submissions. Manage vendor activities and oversee outsourced work including critical reagents, HCP coverage analysis, and CRO support. Lead implementation of new technologies and data‑driven approaches to improve throughput and sensitivity of impurity assays. Author and/or review SOPs, technical protocols and reports, and regulatory filings. Foster a high‑performance culture by coaching and mentoring scientists, promoting scientific excellence, accountability, and ownership. Present findings and strategies at internal cross‑functional meetings, technical forums, and external conferences. Participate in industry consortia on relevant topics and align internal strategies with industry practice. Qualifications Education & Experience Ph.D. in Biochemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences or related discipline with 6+ years of related industry experience, including 5+ years on residual impurity method development; or Master's degree with 12+ years of related industry experience; or Bachelor's degree with 14+ years of related industry experience 2+ years of people management experience with demonstrated ability to coach, develop and motivate high‑performing teams Prior experience in preparing analytical sections of IND, BLA and regulatory responses. Knowledge, Skills and Abilities Deep knowledge of residual impurity assay development (e.g. ELISA for residual protein, qPCR for DNA) Excellent troubleshooting and problem‑solving skills, with a systematic, data‑driven approach to resolving technical challenges Strong sense of accountability and ownership; consistently delivers to project goals and regulatory milestones Ability to manage multiple projects and priorities in a dynamic, cross‑functional environment Skilled in stakeholder management, with clear, proactive, and collaborative communication style Strong technical writing skills and attention to detail in documentation and data review Experience mentoring and developing scientific staff; promotes open communication and teamwork Solid understanding of CMC strategy, regulatory expectations, and phase appropriate analytical requirements Strong track record of independent troubleshooting, root cause investigation, and method remediation for impurity assays Proven success in delivering high‑quality results on time, even under changing priorities and compressed timelines. Demonstrated leadership and influence in cross‑functional matrix environments Preferred Qualifications Familiarity with potency assays, physiochemical assays and other characterization assays Knowledge in novel techniques on detecting and analyzing residual impurities Strong publication record and external scientific presence Experience in fostering partnership with clients through CDMO service Supervisory Responsibilities Yes. This role may supervise Associate Scientist and/or Scientist Additional Information The annual rate of pay for this position ranges from $129,500 - $197,500. For non‑exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits. The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email ******************** or call ************** and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. We do not accept non‑solicited resumes or candidate submittals from search/recruiting agencies. #J-18808-Ljbffr
    $129.5k-197.5k yearly 2d ago
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  • Senior ML & Quantum Chemistry Scientist - Remote

    Qubit Pharmaceuticals

    Remote drug safety scientist job

    A biopharmaceutical firm is seeking a Senior Machine Learning and Quantum Chemistry Scientist to advance quantum chemistry foundation models. The ideal candidate should hold a PhD and have extensive experience in quantum chemistry and machine learning. Responsibilities include model development and communication of research results. The position offers full-time work with health insurance and lunch vouchers, along with remote work options. #J-18808-Ljbffr
    $86k-119k yearly est. 4d ago
  • Senior Responsible AI Scientist - Healthcare Governance (Remote)

    Humana Inc. 4.8company rating

    Remote drug safety scientist job

    A leading health services provider is seeking a Senior Responsible AI Data Scientist. This remote role focuses on ethical AI development across various teams, requiring strong Python skills and experience in the healthcare industry. You'll ensure that AI systems align with organizational values and regulatory standards. Candidates must have a background in quantitative fields with significant experience in machine learning applications. #J-18808-Ljbffr
    $106k-129k yearly est. 2d ago
  • Senior Scientific Director

    Inotiv, Inc.

    Drug safety scientist job in Rockville, MD

    Senior Scientific Director page is loaded## Senior Scientific Directorremote type: Remotelocations: Rockville, MDtime type: Full timeposted on: Posted Todayjob requisition id: JR100920The Senior Scientific Director, Genetic Toxicology is responsible for shaping the scientific strategy for preclinical and regulatory genetic toxicology services that support drug development, chemical and consumer products safety, and regulatory submissions worldwide. The Senior Scientific Director, Genetic Toxicology leads the Genetic Toxicology program, ensuring scientific excellence and full regulatory compliance.**Key Accountabilities*** Serve as the primary scientific advisor for clients in the pharmaceutical, chemical, and consumer product sectors, providing insights on genetic toxicology study design and compliance with international regulations.* Identify and establish partnerships with pharmaceutical, chemical, and consumer product companies to expand service offerings and enhance market presence.* Partner with Business Development to support client relationships and create compelling technical proposals that highlight the scientific and regulatory strengths of our genetic toxicology capabilities.* Represent Inotiv at global scientific and regulatory meetings, conferences, and working groups focusing on Genetic Toxicology.* Drive internal R&D initiatives to expand Inotiv's genetic toxicology service portfolio by leading innovative technologies validations.* Collaborate with Quality Assurance Unit to maintain the highest GLP and OECD compliance standards.* Mentor and develop scientific staff, cultivating a high-performance culture focused on scientific excellence.* Other special projects and duties as assigned**Minimum **Requirements***** Ph.D. in Toxicology, Genetic Toxicology, or related field.* Minimum 10+ years of progressive experience in genetic toxicology, preferably within a CRO and/or regulated industry.* At least 5 years in senior scientific leadership managing GLP-compliant genetic toxicology programs.* Track record of successful client collaboration and program delivery.* Peer-reviewed publications or industry recognition in genetic toxicology.**Skill & Competencies*** Strong understanding of global regulatory frameworks governing genetic toxicology and study design; familiarity with business development processes in the CRO testing industry* Strategic scientific vision combined with business acumen.* Excellent communication, analytical, and problem-solving skills, with the ability to effectively convey complex scientific information to diverse stakeholders.* Strong leadership, mentorship, and communication skills.* Demonstrated ability to build trusted client relationships.* Experience driving innovation and process improvement in a dynamic, fast-paced environment.* The anticipated base salary for this position could range from $180,00.00 to $225,000.00 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience.**Working Conditions & Physical Requirements*** Extended computer and display screen equipment usage* Ability to push, pull, lift 5 pounds unassisted.* Stand / walk for extended period of time.* Fine manipulation including handle touch object or tools and ability to handled controls to perform work.* Ability to read and interpret materials, verbally communicate, and hear required.**Critical Success Factors*** **Customer Focus.** Identifies, prioritizes and anticipates customer needs and delivers relevant, value-add, solutions to meet and exceed them.* **Results Driven.** Internal drive toward action to efficiently, timely, and accurately achieve results. Sets high but achievable standards for self and others. Seeks opportunities to improve process and outcomes. Constantly reviews performance to identify areas to develop.* **Efficient.** Takes responsibility for own time and effectiveness. Identifies what needs to be done and does it before being asked or before the situation requires it. Able to work things out without having to be shown too often. Seeks opportunities to contribute appropriately without direction.* **Communication.** Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication. Able to convey complex information clearly. Anticipates the information that others will need. Expresses ideas effectively. Practices attentive and active listening.* **Collaboration.** Actively supports and contributes to the success of the team. Actively encourages and practices collaboration and cooperation on the team. Shares information and supports other team members. Can get things done with and through others and set realistic objectives. Seeks opportunities to develop others.* ****Relationship Builder.**** Develops, maintains, and strengthens strong partnerships with others internally and externally, cross functionally, in person and remotely.* **Critical Thinking and Problem Solving**. Able to identify and separate out the key components of problems and situations. Able to manipulate and interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this. Can generate a range of creative solutions, evaluate, and choose the most appropriate option* **Improvement Driven.** Inspires and generates new solutions and approaches to issues and challenges to maximize efficiency and effectiveness through everyday practice of root cause analysis and critical thinking problem solving; Continually works to refine skills and abilities; Builds on ideas of others to come up with new ways to address issues or problems; Generates creative new solutions and approaches to issues and processes.* **Organization and time Management.** Plans and prioritizes work, manages time appropriately to meet deadlines, follows up with others to ensure one's own work and commitments are completed on time, deals with pressure and deadlines through good planning.*\*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.**Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.**Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!**Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.*### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.We're #J-18808-Ljbffr
    $225k yearly 5d ago
  • Senior Medical Science Liaison Stroke/Thrombosis (Washington DC)

    Bayer Cropscience Limited

    Drug safety scientist job in Washington, DC

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Senior Medical Science Liaison Stroke/Thrombosis (Washington DC) The Senior Medical Science Liaison (MSL) serves as a trusted scientific expert and partner representing Bayer in the medical community through the dissemination of and education on scientific data related to Bayer products across the product lifecycle. The MSL establishes proactive long‑term scientific/strategic relationships with key, influential healthcare providers, and stakeholders, and with major medical associations and academic centers of excellence. These relationships will ensure that healthcare providers and organizations have access to relevant scientific information and that pertinent information is shared with the medical community. The MSL serves as technical and scientific support in the field for healthcare providers ensuring safe and effective use of Bayer products including timely adverse event reporting and responses to unsolicited requests for detailed product and disease state information. The MSL also develops a complete understanding of national, regional, and local experts and stakeholders in specific therapeutic categories and the healthcare environment in which they work. The MSL is an expert in specific therapeutic areas covering a specific region and Area Business Unit, collaborating with internal business partners and external contacts addressing specific scientific and educational needs. The Territory will cover: Washington DC and surrounding area. YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Senior Medical Science Liaison, Stroke/Thrombosis are to: Scientific Expertise Complete core training curriculum and basic MSL and Therapeutic Area (TA) Certification; Demonstrated accountability to continuous learning and growth (Franchise data, MSL role, Soft Skills, Personal Development). Completes recertification where applicable; Professional licensure with CEU documentation where applicable; Depth of knowledge within the therapeutic area exceeds that of peers and/or Medical Affairs experience in multiple therapeutic areas; Coordinates and lead TA updates, team discussions, training initiatives (i.e. journal clubs); Attend and report on local, regional and national medical conferences and other meetings of value; Coordinate team coverage of major regional or national meetings including program evaluation, required attendance and coordination of high quality meeting reports; Identifies educational gaps and provides subsequent recommendations for educational resource, content, or initiative development. External HCP and Stakeholder Engagement Establishes robust long‑term relationships with Thought Leaders and other key stakeholders through education on up to date scientific information in alignment with US, Global, and Area Business Unit definitions and strategies; Impactful proactive engagement with TLs, HCPs, research sites, associations, societies, & other stakeholders according to defined scope and engagement plans. Actively seeks future stakeholders and emerging Thought Leader groups in alignment with local health care system and medical strategy; Leverage knowledge of US and Global definitions and strategies to develop and pull through local Area Business Unit strategy; Responsible and Accountable for driving medical strategy by translating the local medical plan into implementable TL and stakeholder engagement strategies with cross‑functional teams and identify synergies with the interests of Bayer and the general medical community; Approach accounts, customers, and Area Business Unit strategically, utilizing key metrics to ensure alignment to territory plan and medical objectives; Compliantly supports speaker training and evaluation and medical evaluation of scientific merit; Advisory Board or other Bayer Program coordination or support during meeting; Coordinates TL engagement with Franchise Medical Affairs team and relevant internal stakeholders. Education Delivers educational presentations to external audiences, stakeholders, and customers groups. Proactive identification of educational opportunities within assigned Area Business Unit to stakeholders or customers groups; Responsible for timely, accurate, specific and balanced responses to Medical Inquiries in collaboration with Medical Communications; Adherence to SOP and FDA guidance for distribution of scientific information; Adherence to SOP and compliance guidelines for all external contacts; Prepares and presents data to internal audiences including MA and Commercial partners. Research Responsible for supporting research projects aligned with medical and brand strategy; including facilitating investigator‑initiated research (IIR) and research site identification; Responsible for supporting clinical trial team and engaging with appropriate stakeholders for Bayer sponsored clinical trials. Support with data collection, feasibility & initiation visits, and study support as appropriate. Insights Responsible and Accountable for generating relevant HCP and stakeholder insights that deepen understanding of patients, HCPs, consumers, or treatment landscape. Document and communicate them accordingly within system or to stakeholders to inform, refine, and enhance tactics and strategy; Report new compound development information and potential collaborations when appropriate or requested in line with corporate strategy. Collaboration Compliant active strategic partnership and collaboration with territory cross‑functional stakeholders (i.e. Area General Manager, Area Business Unit team, Field DGOS, etc.) as part of Area Business Unit team; Presentations to internal audiences including Therapeutic Area Medical Affairs (MA) or commercial partners; Lead project teams or task forces as appropriate within Franchise Medical Team; Initiates best practice discussions for MSL team and internal partners; Responsible and accountable as MSL mentor as appropriate. New Ways of Working (Data Collection / Analysis / Interpretation) Internal champion of new ways of working including platforms, systems, capabilities. Train, mentor, and empower Field Medical team to leverage new ways of working; Complete all required customer activity documentation, training, expense reporting, and other administrative responsibilities in a timely, accurate, and compliant manner; Responsible for reviewing and interpreting interaction analytics related to TL engagement and take appropriate actions to execute stakeholder plans; Use data and analytics to seek out and maximize customer engagement opportunities within the territory; Leverage evolving country and Global platforms and systems to ensure data driven tailored approach to customer engagement; Leverage omnichannel methods of engagement with stakeholders to ensure customer‑centric approach to data dissemination and education. WHO YOU ARE Bayer seeks an incumbent who possesses the following: Required Qualifications BA/ BS Degree is required; Experience in a scientific or healthcare clinical setting; or pharmaceutical industry experience in Medical Affairs, Sales, Marketing or Clinical Development; or post‑graduate fellowship experience in a hospital or industry setting; Rotations or fellowships do not contribute to above requirements; MSL experience is required; Demonstrated project management ability; Demonstrated expertise in communicating scientific information; Excellent oral and written communication skills; Excellent interpersonal skills; Demonstrates understanding of clinical trial design; Ability to critically evaluate the medical literature; Ability to work in a team environment; Established ability to build productive work relationships both internally and externally; Travel 50+% and manage a demanding schedule; Valid Driver's License and eligibility to drive a company car or pooled vehicle (driving record must meet guidelines base on the company's Risk Screening for Hiring Drivers and MVR will be reviewed as part of pre‑employment screening). Preferred Qualifications Advanced terminal Doctorate degree in medical or health sciences (e.g M.D., PhD, PharmD, DPH, EdD) or an advanced degree in Pharmacology, Pharmacy, Medicine, Nursing or equivalent experience is preferred; Working knowledge of FDA, OIG requirements; A minimum of 1 year MSL experience or 2 years experience working within the pharmaceutical/biotech industry or post‑graduate fellowship experience in a hospital or industry setting. Area of expertise in neurology, stroke, thrombosis, or anticoagulation, preferred. Employees can expect to be paid a salary of between $156,000 to $234,000. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least: 1/20/2026. Your Application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third‑party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans. Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer is an E‑Verify Employer. Contact Us Email: hrop_************* Job Details Location: United States : District of Columbia : Residence Based || United States : District of Columbia : Washington || United States : Virginia : Residence Based Division: Pharmaceuticals Reference Code: 859989 #J-18808-Ljbffr
    $156k-234k yearly 3d ago
  • Neuroimmunology Medical Science Liaison - Mid-Atlantic

    Johnson & Johnson 4.7company rating

    Drug safety scientist job in Washington, DC

    A leading healthcare company is seeking a Medical Science Liaison focused on neuroimmunology in the Mid-Atlantic territory, including Washington D.C. The role involves building relationships with healthcare providers, developing strategic plans, and providing scientific information. Candidates must possess a PharmD/PhD/MD and have relevant experience in neurology, immunology, or similar fields. The role offers a competitive salary range of $115,000 - $197,800, annual bonuses, and comprehensive employee benefits. #J-18808-Ljbffr
    $115k-197.8k yearly 6d ago
  • Medical/Senior Medical Science Liaison, Northeast

    Zevra Therapeutics, Inc.

    Drug safety scientist job in Washington, DC

    Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies. With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and common-sense perspective have successfully overcome complex development challenges to make much-needed therapies available to patients. Nimble and dauntless, we push boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients' lives. About the role The Medical Science Liaison (MSL) serves as a scientific and clinical expert, engaging with healthcare professionals (HCPs), key opinion leaders (KOLs), researchers, and decision-makers to advance understanding of rare diseases and Zevra's therapeutic portfolio. This field-based role supports evidence generation, clinical initiatives, and scientific exchange to improve patient outcomes. The ideal candidate will maintain deep knowledge of disease states, products, competitors, marketplace, and regulatory guidance, and will provide medical information in a fair and balanced manner. Candidates should have strong scientific expertise and business acumen, with an optional interest or background in data science. Territory Northeast U.S. (NY, NJ, MA, PA, VA, DC, MD, DE, RI, MA, VT, NH, CT, WV) What you'll do Serve as a credible medical/scientific expert engaging with KOLs and HCPs to increase confidence in clinical decision-making for rare diseases and Zevra's products. Build deep, strategic, long-term relationships with internal and external stakeholders to be viewed as a trusted partner. Maintain comprehensive knowledge of disease states and competitive landscapes. Stay current on scientific and clinical developments in Zevra's Areas of Interest (AOI). Conduct peer-to-peer scientific discussions and provide accurate, balanced medical information. Engage in projects and initiatives aligned with US Medical strategy, objectives, and tactics. Facilitate discussions with HCPs and potential investigators regarding research strategies and trial participation. Represent Zevra at scientific congresses and medical meetings. Educate internal teams on disease states, product science, and therapeutic guidelines. Contribute to publication planning and medical information resources. Capture and report HCP medical insights using Veeva with consistency and accuracy to inform medical and clinical strategies. Qualifications Advanced scientific or clinical degree (MD, PhD, PharmD, DNP preferred). Experience: Minimum 2 years as an MSL or similar role in pharma/biotech for MSL level. Minimum 5 years for Senior MSL level. Must reside within the territory. Clinical expertise in Rare Diseases (experience in lysosomal, metabolic, or rare neurological disorders preferred). Strong communication skills and ability to engage diverse audiences. Business acumen and compliance awareness. Ability to travel 60-75%, including overnight and occasional weekends. Valid driver's license. Equal Employment Opportunity Statement Zevra 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. Notice to External Recruiters Zevra does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation. Medical Affairs and Advocacy Remote (Washington, District of Columbia, US) #J-18808-Ljbffr
    $108k-218k yearly est. 3d ago
  • (Senior) Medical Science Liaison - Mid-Atlantic

    Tempus, Inc. 4.8company rating

    Drug safety scientist job in Washington, DC

    (Senior) Medical Science Liaison - Mid-Atlantic page is loaded## (Senior) Medical Science Liaison - Mid-Atlanticlocations: Remote - District of Columbia: Remotetime type: Full timeposted on: Posted Yesterdayjob requisition id: JR202500823Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. We are looking for a high-performing and experienced field Medical Science Liaison (MSL/Sr. MSL) to support Tempus's innovative objectives, including physician support, education on medical advancements, and gathering insights for future developments. A successful candidate will possess strong clinical and scientific background in oncology and comprehensive genomic profiling. This role requires excellent communication and presentation skills to educate oncologists, pathologists, and advanced practice providers about Tempus assays and technologies. We are considering candidates residing in MD/DC/VA(Northern), and be able to travel 50%. ****Responsibilities***** Serve as a subject matter expert supporting commercial team efforts with deep and current understanding of the oncology landscape, including diagnostic tests, disease states, treatment paradigms, and emerging biomarkers and technologies.* Build relationships with Key Opinion Leaders (KOLs) and other HCPexperts, including oncologists, pathologists, lab directors, and researchers.* Deliver scientific presentations and promote exchange of clinical/scientific/technical information with regional KOLs, community physicians, medical directors, and other HCPs in the field of oncology regarding Tempus oncology products. This will include proactive and reactive communication of scientific data.* Facilitate discussions for insights in clinical research, unmet needs, and emerging trends in testing practices.* Provide scientific education for internal stakeholders in collaboration with Learning & Development team* Continuously update internal stakeholders on relevant medical and scientific insights as well as proactively sharing market intelligence.****Required Skills***** Fundamental understanding of the field of molecular oncology, comprehensive genomic profiling, tumor evolution, and relevant targeted therapy options in early and advanced stage cancer, with ability to interpret clinical trial data.* Existing KOL relationships in the field of oncology.* Working knowledge of genomic laboratory-developed testing (LDT) with tissue and liquid biopsy; familiarity with CLIA-88', CAP, Sunshine Act (2013).* Proficient public speaking skills with an ability to effectively communicate clinical data and complex scientific concepts.* Exceptional interpersonal communication skills, strong inter-, and intradepartmental management skills, ability to educate and train.* Self-starter, who can work autonomously to deliver on tight timelines.* Ability to travel (50%).****Education and Experience***** Advanced scientific or medical degree (PhD, PharmD, MD, MSN, BSN)* Basic understanding of oncology required; basic understanding of molecular testing strongly preferred.****Preferred Qualifications***** 1+ years of MSL experience in diagnostics, biotech or pharmaceutical industries.****#LI-GL1********#LI-Remote****Salary Range: $120,000 - $190,000 USDWe are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.We're looking for people who can change the world.Who question the status quo and don't shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We're looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on. #J-18808-Ljbffr
    $120k-190k yearly 6d ago
  • Respiratory Medical Science Liaison - Northwest (Remote)

    Chiesi Farmaceutici S.P.A

    Remote drug safety scientist job

    A global biopharmaceutical company is seeking an Executive Medical Science Liaison in Seattle, WA to advance KOL partnerships in Respiratory therapeutic areas. The role involves engaging with healthcare professionals, delivering medical education, and supporting research initiatives. Candidates should have a graduate degree and extensive MSL experience, particularly in Asthma/COPD. The position offers a competitive salary and comprehensive benefits, emphasizing diversity, development, and sustainability. #J-18808-Ljbffr
    $100k-228k yearly est. 2d ago
  • Chief Scientist - Earth Science Modeling

    National Science Teachers Association 4.0company rating

    Drug safety scientist job in Silver Spring, MD

    ERT is seeking a Chief Scientist with experience in meteorology or atmospheric sciences, or other earth sciences to support tasks at National Oceanic and Atmospheric Administration's (NOAA) Earth Prediction Innovation Center (EPIC). The primary objective will be to enhance the research-to-operations-to-research pipeline for the weather forecasting community with the goal of improving the overall accuracy and reliability of US National Weather Service weather models. All research and development will be guided by the NOAA open‑source science principles. Required Skills 15+ years of experience in position of increasing responsibility and leadership in the field of climate or earth systems science, weather modeling and forecasting, or a closely related discipline. Facility with the computational and technical operational components of handling and using earth systems data for large-scale forecasting. Must be able to pass a background investigation to obtain a security badge to enter the applicable government facility. Education MS degree in atmospheric science, earth science or closely related discipline. PhD preferred. Location This position supports work at NOAA's Silver Spring, MD facility with some telework permitted. Compensation The salary range for this role is $46,000 - 221,000/year. This range is a good faith estimate based on similar roles across the organization. ERT considers several factors when extending an offer of employment, including the location, scope, and associated responsibilities of the specific position, as well as a candidate's work experience, education/training, and key skills. Benefits All full‑time employees are eligible to participate in our flexible benefits package, which includes: Medical, Rx, Dental, and Vision Insurance 401(k) retirement plan with company‑matching 11 Paid Federal Government Holidays Paid Time Off (PTO) Basic Life & Supplemental Life Health Savings Account, Flexible Spending and Dependent Care Flexible Spending Accounts Short‑Term & Long‑Term Disability Employee assistance program (EAP) Tuition Reimbursement, Personal Development & Learning Opportunities Skills Development & Certifications Professional Membership Reimbursement Employee Referral Program Competitive compensation plan Discretionary variable incentive bonuses based on factors such as individual performance, business unit performance, and/or the company's performance Publication and Conference Presentation Awards with bonuses ERT is a VEVRAA Federal Contractor and Equal Opportunity Employer - All qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status. #J-18808-Ljbffr
    $46k-221k yearly 4d ago
  • Medical Science Liaison (57364)

    Praxis Precision Medicines Inc.

    Remote drug safety scientist job

    Job Details Position Type: Full Time Travel Percentage: Minimum of 2x/year to Boston area Job Category: Biotech The Opportunity: We are seeking highly engaged individuals to represent Praxis Precision Medicines in the role of Medical Science Liaison. In this field‑facing role you will provide a critical link to Health Care Providers, clinical trial sites and personnel, and both professional and patient organizations. You'll be responsible for building long‑term relationships with key stakeholders through targeted scientific exchanges and respond to unsolicited requests for information about the company's development programs and products. We are seeking to fill multiple positions for this role, which involves 50% to 75% travel. We offer flexibility on candidate location, including temporary out of region residency options for exceptional candidates who are a strong match for both the role and company. Primary Responsibilities Develops and/or delivers presentations to Healthcare Professionals (HCPs), Academic Institutions, payors, patient advocacy groups, and professional organizations. Represents the company in medical scientific congresses and conferences. Develops, organizes, and carries out Advisory Boards, Round Tables, Regional Medical Meetings, Symposia, as needed. Educate investigators and site staff on trial protocols, eligibility criteria and ensure that there is a thorough understanding of the investigational product being used in the study. Identify new trial sites and work with established sites to accelerate enrollment of subjects. Stays current on therapeutic areas of interest for the company and competing development programs. Supports adherence to relevant regulatory requirements and Company Policies and Standard Operation procedures (SOPs). Qualifications and Key Success Factors Experience managing the support of clinical development programs and/or commercialized products in Neurology, in particular Movement Disorders or Epilepsies. Advanced degree (e.g., PharmD, M.D. or Ph.D.) in a scientific discipline and 3 to 5+ years' experience in an MSL role. Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment. Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms. Highly organized and detail‑oriented with a passion to deliver quality results. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices. Compensation & Benefits At Praxis, we're proud to offer an exceptional benefits package that includes: 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans Bonus program structured to pay on a quarterly basis 401k plan with 100% match up to 6% of employee's contribution (Traditional & Roth) Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit Eligibility for equity awards and Employee Stock Purchase Plan (15% discount) To round out this world‑class total rewards package, we provide base salary compensation in the range of $155k to $170k annualized. Final salary range may be modified commensurate with job level, education, and experience. Company Overview Praxis Precision Medicines is a clinical‑stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. #J-18808-Ljbffr
    $155k-170k yearly 3d ago
  • Dermatology Medical Science Liaison Lead

    Eli Lilly and Company 4.6company rating

    Drug safety scientist job in Washington, DC

    A leading global healthcare firm is seeking a Medical Science Liaison to engage with scientific experts and facilitate communication of medical information. You will establish yourself as a reliable resource, involved in customer engagement and strategic analysis while working closely with cross-functional teams. The role requires an advanced health sciences degree and relevant experience, alongside strong communication and analytical skills. Travel up to 80% may be required in this full-time position. #J-18808-Ljbffr
    $125k-174k yearly est. 5d ago
  • Principal Research Scientist - AI & Machine Learning

    Novateur Research Solutions

    Drug safety scientist job in Ashburn, VA

    Novateur stands for Innovation. We value creativity, vision, collaboration, and above all, ambition to innovate. Novateur Research Solutions is an R&D firm located in Northern Virginia, developing intelligent systems that push the boundaries of computer vision, AI, and large-scale learning. We are hiring a Principal Research Scientist to lead cutting-edge programs in AI, computer vision, and intelligent systems. This role offers leadership opportunities to define new research directions and shape next-generation technologies. Responsibilities: • Serve as PI or co-PI on government-funded R&D programs. • Conceive, design, and oversee research in learning systems, spatiotemporal modeling, and geo-localization. • Publish, present, and contribute thought leadership to the AI community. • Mentor research staff and guide proposal development. Requirements: • PhD with 7+ years of research experience. • Demonstrated leadership in ML, vision, or scientific computing. • Record of funding, publications, and technical impact. • U.S. Citizen or Permanent Resident. Preferred: • Experience with multimodal learning, uncertainty quantification, or causal inference. Why Novateur? Join a team that values creativity and initiative. At Novateur, you'll lead transformative projects that redefine what's possible in intelligent systems. Company Benefits: Novateur offers competitive pay and benefits comparable to Fortune 500 companies that include a wide choice of healthcare options with generous company subsidy, 401(k) with generous employer match, paid holidays and paid time off increasing with tenure, and company paid short-term disability, long-term disability, and life insurance. We offer a work environment which fosters individual thinking along with collaboration opportunities within and beyond Novateur. In return, we expect a high level of performance and passion to deliver enduring results for our clients.
    $86k-125k yearly est. 18h ago
  • Principal Associate, Data Scientist - LLM Customization Team

    Capital One 4.7company rating

    Drug safety scientist job in McLean, VA

    * Partner with a cross-functional team of data scientists, software engineers, machine learning engineers and product managers to deliver AI powered products that change how customers interact with their money.* Leverage a broad stack of technologies - Pytorch, AWS Ultraclusters, Hugging Face, LangChain, Lightning, VectorDBs, and more - to reveal the insights hidden within huge volumes of numeric and textual data.* Be the expert in Natural Language Processing (NLP) to harness the power of Large Language Models (LLMs), adapt and finetune them for customer facing applications and features.* Build machine learning and NLP models through all phases of development, from design through training, evaluation, and validation; partnering with engineering teams to operationalize them in scalable and resilient production systems that serve 80+ million customers.* Flex your interpersonal skills to translate the complexity of your work into tangible business goals.* Customer first. You love the process of analyzing and creating, but also share our passion to do the right thing. You know at the end of the day it's about making the right decision for our customers.* Innovative. You continually research and evaluate emerging technologies. You stay current on published state-of-the-art methods, technologies, and applications and seek out opportunities to apply them.* Creative. You thrive on bringing definition to big, undefined problems. You love asking questions and pushing hard to find answers. You're not afraid to share a new idea.* A leader. You challenge conventional thinking and work with stakeholders to identify and improve the status quo. You're passionate about talent development for your own team and beyond.* Technical. You're comfortable with advanced ML and DL technologies including language models and are passionate about developing further. You have hands-on experience working with LLMs and solutions using open-source tools and cloud computing platforms.* Influential. You are passionate about AI/ML and can bring along a cross functional team in breakthrough innovations. You communicate clearly and effectively to share your findings with non-technical audiences.* You are experienced in training language models or large computer vision models as well as have expertise in one or more key subdomains such as: training optimization, self-supervised learning, explainability, RLHF.* You have an engineering mindset as shown by a track record of delivering models at scale both in training data and inference volumes. You have experience in delivering libraries, platforms, or solution level code to existing products.* A Bachelor's Degree in a quantitative field (Statistics, Economics, Operations Research, Analytics, Mathematics, Computer Science, or a related quantitative field) plus 5 years of experience performing data analytics* A Master's Degree in a quantitative field (Statistics, Economics, Operations Research, Analytics, Mathematics, Computer Science, or a related quantitative field) or an MBA with a quantitative concentration plus 3 years of experience performing data analytics* A PhD in a quantitative field (Statistics, Economics, Operations Research, Analytics, Mathematics, Computer Science, or a related quantitative field)* Master's Degree in “STEM” field (Science, Technology, Engineering, or Mathematics) plus 3 years of experience in data analytics, or PhD in “STEM” field (Science, Technology, Engineering, or Mathematics)* At least 1 year of experience working with AWS* At least 3 years' experience in Python, Scala, or R* At least 3 years' experience with machine learning* At least 3 years' experience with SQLCapital One offers a comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being. Learn more at the . Eligibility varies based on full or part-time status, exempt or non-exempt status, and management level. #J-18808-Ljbffr
    $71k-90k yearly est. 5d ago
  • Research Scientist

    CNA Corporation 4.6company rating

    Drug safety scientist job in Arlington, VA

    PRIMARY PURPOSE CNA is hiring for Research Scientists to join their Advanced Technology Assessments (ATA) division. Staff at this level will typically be leading smaller and/or less complex projects, playing a critical role as a team member on projects with specific technical/scientific expertise. As part of the Department of the Navy's Federally Funded Research and Development Center (FFRDC), CNA's Advanced Technology Assessments (ATA) division provides analysis that evaluates the military utility and efficacy of emerging defense technologies and prototypes, operational test and evaluation of DoD programs of record, and tactics development and resourcing decisions for existing naval aircraft. Analyses from ATA help the Navy make data-informed resourcing, training, and modernization decisions for new and existing defense technologies, with a focus on naval aircraft. Our research supports defense innovation programs to ensure operational effectiveness and lethality and to maintain the technological superiority of US military forces. ATA also contributes independent analyses to the testing of new aviation systems and the development of tactics to optimize the effectiveness of existing aircraft. ATA Scientists typically work collaboratively and independently with research staff from other research areas across the FFRDC, as well as with some sponsors and staffs. They have demonstrated research and analysis experience, and they require less direction and supervision than entry-level research staff. CNA fosters an inclusive culture that values diverse backgrounds and perspectives. Our flexible and engaging work environment encourages iterative and creative collaboration at every stage of the problem solving process. Our employees are committed to helping clients develop effective solutions to better manage their programs through scientific, data-driven approaches. We are looking for creative and innovative individuals to help carry out our mission. JOB DESCRIPTION AND/OR DUTIES 1. Routinely produces analysis on structured and unstructured problems that meets CNA's quality standards with limited direction and general supervision. Demonstrates ability to develop and apply creative and innovative analytic solutions to complex problems with assistance/support from more senior staff. Shows the ability to synthesize analytic results into a broader context. Can lead complex analytic projects with supervision. Begins to make connections and synthesize ideas across multiple, related studies. 2. Develops and maintains deep, specific institutional knowledge and expertise of primary clients/sponsors; their culture, organization, and issues. Uses that knowledge to support training & mentoring of new staff, to support on-going work, and to support development and shaping of new work for existing clients/ sponsors. 3. Balances responsiveness to guidance with independent action. Contributes productively and harmoniously to the work of others; treats everyone respectfully, professionally and fairly. Independently identifies opportunities for collaboration within team, division, and operating unit. Supports supervisor's initiatives and helps make vision a reality. Recognizes and acknowledges contributions from subordinates. 4. Supports business development efforts and/or marketing activities by interacting with CNA managers and current clients/sponsors on securing follow on work (e.g., small grants, or above core projects), expanding or developing new ideas for future projects, and occasionally working with potential clients/sponsors on developing new project ideas. Occasionally serves as internal reviewer of technical proposals. 5. Interacts regularly and independently with clients/sponsors and related parties. Typical interactions are at the "peer equivalent" level, but some level of interaction at senior level. Can effectively represent CNA as an organization. 6. Influences decisions by sponsors/ clients; provide sponsors/clients with implementable recommendations. Occasionally supports efforts to enhance CNA's reputation via publishing and outreach activities. 7. Demonstrates strong and effective communications skills, to include ability to summarize and synthesize larger pieces of work into effective executive summaries/executive briefings. Can effectively present work to more senior and larger audiences. Effectively communicates with & engages colleagues at all levels of the organization. 8. Works under limited direction and general supervision from division management. Can lead projects of low to medium size and/or complexity, as well as significant tasks on large or more complex projects. Effectively manages all aspects of assigned projects, to include delivery of high-quality analytic products on-time, and on-budget. 9. Plays a supporting role in the mentoring and training of new staff individually or as a member of a project team. Regularly demonstrates initiative in pursuing improvements in the quality of our projects and analytic products. Participates in corporate initiatives when asked to do so, and makes contributions to initiatives focused on making CNA a better place to work. 10. Performs other duties as assigned. JOB REQUIREMENTS 1. Education: Minimum Master's degree in a relevant field or equivalent experience, PhD preferred. Background in STEM preferred. 2. Experience: Typical minimum requirements 5+ years of experience in research and analysis, preferably in the national defense arena (within the Department of the Navy or in the context of an FFRDC or a University Affiliated Research Center is a plus). 3. Skills: Experience using programming tools for analyzing large datasets, perform numerical computations, and create visualizations is preferred. Relevant tools include Python, R, and MATLAB. Ability to work on progressively more difficult projects/analyses, including directing portions of large research projects or small to medium projects under general supervision Ability to operate independently and proactively in the execution of assignments; Ability to work in a multi-disciplinary environment Strong critical thinking skills Knowledge of research techniques Strong planning and organizational skills Excellent interpersonal skills Strong and effective oral and written communication skills Ability to interact directly and effectively with clients and influence their decisions. 4. Working environment: The ATA Division conducts mostly classified work that must be done at CNA's facility in Arlington, VA. However, in those situations where analysts are working on unclassified parts of a classified study or on a study that is not classified, we offer a hybrid working environment that allows analysts to work off-site (typically from home). Some amount of travel is expected to meet with clients and sponsors outside of the greater Washington, DC area. 5. Other: Ability to obtain and maintain an Active Secret Security Clearance; TS/SCI Clearance eligibility is preferrable. Required Documents Resume or CV - Please upload your resume or CV Cover letter - Please upload a cover letter as part of your application that introduces yourself, summarizes your relevant skills and experiences, and describes why you would be a valuable asset to CNA's ATA Division. Writing Sample - Please upload a research paper or journal article that demonstrates your writing and research skills (draft copies are acceptable). Optional documents Transcripts (highly desired) - In a later stage of the hiring process, we may require your undergraduate and graduate transcripts. To have them considered as part of your application now, please upload them with your resume or CV. Letters of recommendations (highly desired) - In a later stage of the hiring process, we may require letters of recommendation or professional references for us to contact. CNA offers competitive salaries and a comprehensive benefits package, which includes health, dental, and vision insurance, life and disability insurance, and a 403(b) retirement plan with employer matching. Additionally, we provide generous paid time off programs to promote a health work-life balance. Eligibility for these benefits varies based on employment classification. CNA is committed to providing equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service and protected veterans, or other non-merit based factors. In addition to federal legal requirements, CNA complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. These protections extend to all terms and conditions of employment, including recruiting and hiring practices, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training and career development programs. For more information about EEO protections, please view the EEO is the law posters here: "EEO is the Law" Poster", "EEO Poster Supplement". The pay transparency policy is available here: Pay Transparency Nondiscrimination Poster. To be considered for hire, all individuals applying for positions with CNA are subject to a background investigation. For positions requiring access to classified information, U.S. citizenship is required. Individuals will also be subject to an additional government background investigation, and continued employment eligibility is contingent upon the ability to obtain and maintain an active security clearance.
    $69k-96k yearly est. 1d ago
  • Safety Scientist

    Mindlance 4.6company rating

    Remote drug safety scientist job

    Work from Home answer: There is no routine work from home, but we do allow contractors on an occasional basis at the discretion of the manager and dependent on things such as work volume, employee being in good standing, etc. Requests to work from home must be made in advance, and may be denied at the discretion of the manager. In instances of inclement weather, we would allow our contractor and permanent employees to work (safely) at home Contract duration 6 months with option to extend. Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required Maintain a listing of all administrative changes and updates Ensure all processes as described are operational Alert Project Management when activities fall outside SOW Process and evaluate AE reports according to the customer's standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings Assist in the reconciliation of clinical and safety databases Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports Perform literature review for identification of case reports and other relevant safety information Liaise with both internal and external vendors (clients, patients and HCPs) Review/Quality check (QC) of source documents, coding, data entry, report generation and distribution Monitor compliance metrics and ensure appropriate documentation when deficient Assist in evaluation and validation of systems to support safety Other duties as assigned by management Qualifications Registered Nurse, Pharmacist, or other degree in a science or health-related field Good knowledge of global and local PV regulations and legislation, both pre-and post-marketing required. Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g., CRO) with case processing responsibilities Pharmacovigilance (PV) reporting experience should include drugs and biologics. Experience with safety surveillance of vaccines and medical devices a plus but not required Proficient with case processing including use of coding dictionaries, case narratives preferably within ARISg and/or Argus. Proficient with computer programs (MS Word, PowerPoint, Excel) Good communication, interpersonal interaction, and organizational skills are essential Ability to manage multiple client projects simultaneously with good time management skills. Fluent in English, additional language fluency a plus, but not required Additional Information Thanks & Regards, Mahesh Kumar | Team Recruitment | Mindlance, Inc. | W : ************ ****************************
    $76k-110k yearly est. Easy Apply 1d ago
  • Clinical Scientist - Interventional

    Gehc

    Remote drug safety scientist job

    SummaryAs the Clinical Scientist - Interventional, you will be responsible for working daily in close partnership with Interventional key clinical partners as well as global and local GE HealthCare colleagues. You will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionEssential Responsibilities: Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership Support adoption of new technology or clinical applications through advocacy and evidence Participate in customer presentations regarding use of Interventional products for institution research purposes Closely connected with GEHC global modality clinical and research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns Grow technology leadership mindshare through joint scientific presentations and publications Lead and represent the global modality technical, scientific and product expertise in the US and Canada to support local clinical teams and best-in-class customer experience on new products Study new technology concepts and leverage expertise to move initiatives forward Qualifications/Requirements: PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research Experience with imaging modalities and dose analysis Knowledge of Interventional procedures, anatomies, clinical practice Knowledge of Interventional products including IGS product line and Advantage Windows applications Excellent customer relationship management and collaboration skills Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Desired Characteristics: 5 + years experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $100,000.00-$150,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes
    $100k-150k yearly Auto-Apply 5d ago
  • Associate Scientist I

    Microbac Laboratories, Inc. 4.0company rating

    Drug safety scientist job in Sterling, VA

    Come join our family! Microbac Laboratories is an essential business offering competitive pay and benefits including medical, dental, vision, life insurance, disability, generous paid time off including vacation, holidays and flex-time, a wellness program, referral bonus, tuition reimbursement and more! Whether you are just starting your career in science or looking to further it, Microbac will put you on the path of an exciting career with room to grow. Quality, safety, giving back to our communities, diversity and inclusion, customer success and employee wellbeing are part of our core culture. We are looking for motivated individuals to join our family as an Associate Scientist I . ABOUT MICROBAC Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients worldwide, offering laboratory solutions to the life science, food and nutrition, and environmental industries and serves our clients with the utmost expertise and respect for their market requirements, constraints, and challenges. We embody a company-wide commitment to exceptional customer experience, which has been refined over nearly 50 years of trusted, analytical and measurement experience. Through our network of laboratories, offices, and field services, we have the flexibility to meet the unique requirements for each client, project, and scope. As a privately held third-party testing company, Microbac operates with a commitment to safety, quality, and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and nutrition and life science markets. JOB SUMMARY The Associate Scientist I, working in an accredited commercial laboratory, is responsible for assisting with the conduct of microbiological assays and associated activities to determine antimicrobial efficacy of household and commercial cleaning products. ESSENTIAL FUNCTIONS: Following established SOP's and adhering to state, federal and other accrediting body requirements, collect information about the antimicrobial properties of substances/samples to support the analytical testing needs of our clients for such purposes as quantitative or qualitative analysis, and product development Perform laboratory housekeeping duties to include autoclaving and glassware processing Prepare necessary standards, solutions, reagents, media, etc., required for sample analyses Perform equipment and instrumentation set up Operate basic and specialized laboratory instrumentation Prepare and analyze samples Accurately record observations and data and interpret results Assists in the development and validation of new analytical methods Assists in the development of new laboratory procedures Assist department supervisors and managers with staff training Sign off on final certificates of analysis Contribute to writing, editing, and reviewing SOP's Monitor and address sample backlog issues Perform peer review of data to ensure accuracy Maintain accurate, up to date logs, notebooks, and equipment records Perform necessary laboratory administrative functions such as filing paperwork, photocopying, reviewing of data, and entering data into computerized LIMS Comply with and promote Personnel, Safety, and Quality Program MINIMUM REQUIREMENTS: Bachelor's degree from a four-year accredited institution in a related field of applied science Prior analytical testing experience Above average knowledge of principles, terminology, practices, techniques, and instrumentation commonly used in a laboratory setting Ability to interpret data and prepare reports Ability to effectively prioritize work and manage time to meet deadlines and rush orders Computer literacy Ability to work with delicate laboratory equipment Ability to communicate effectively in both written and verbal formats WORKING CONDITIONS AND PHYSICAL REQUIREMENTS: The physical demands and working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Requirements: While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools; talk or hear. The employee is required to stand, walk, and sit. The employee must regularly lift and/or move up to 25 pounds. Specific vision abilities required by this job include color vision and depth perception. Working Conditions: While performing the duties of this job, the employee will be in a general laboratory and office environment. The noise level in the work environment is usually moderate. This job may require travel less than 20% As a privately held third-party testing company, Microbac operates with a commitment to safety, quality and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and life science markets. OTHER: This is not an exhaustive list of all duties an employee may be required to perform. Microbac reserves the right to revise the job description at any time. Employment is at-will. Microbac, promotes a drug-free, alcohol-free workplace. Applicants considered for hire must pass a drug test before beginning work. Refusal to submit to testing will result in disqualification of further employment consideration. Microbac is an Equal Opportunity Employer - We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. All qualified applicants will receive consideration for employment.
    $55k-79k yearly est. Auto-Apply 39d ago
  • Associate Scientist

    Us Tech Solutions 4.4company rating

    Drug safety scientist job in Gaithersburg, MD

    US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website ************************ We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well. Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset. Job Description • BioProcess Engineering (BPE) department is responsible for scale up, tech transfer, and facility fit of clinical and commercial processes to manufacturing. BPE is also responsible for producing development drug substance material and data from pilot facilities. Members of Development Scale-up Center (DSC), within BPE, produce materials up to 500L scale for toxicology and process development studies, to confirm process performance and to troubleshoot issues in GMP facility, and work with cross functional team on technology evaluations. • This position is focused on upstream cell culture and fermentation processes supporting scalability and production of therapeutic proteins in DSC. Position is a hands-on laboratory and production-based role. Responsibilities include but are not limited to media preparations, routine sub-culturing of cells and fermentations. The candidate will assist in adaptation of transferred information for scale-up processes from late stage development to DSC as well as assisting in the production of various tox and development materials, troubleshooting and resolving technical issues with the production processes and/or equipment, identifying root causes for deviations, implementing corrective/preventative actions, assisting in implementing new technologies, and trending/analyzing data. • The candidate will assist in compiling data and expected to summarize and assist in interpreting results. The candidate will also maintain production and laboratory equipment. Qualifications Education: • Bachelor of Science (BS) or Master of Science (MS) in scientific, engineering or related field. Experience: • For the RA, we require a BS with 2 - 5 years or a MS with 0 - 2 years of relevant experience. • For the AS, we require a BS with a minimum of 5 years or MS with a minimum of 2 years of relevant experience. Additional Information Special Skills/ Abilities • Hands on proficiency in cell culture and/or fermentation and good aseptic techniques. Bioreactor/fermenter operation experience is preferred. • Good documentation, writing and communication skills in a team based setting are essential.
    $56k-84k yearly est. 1d ago
  • Associate Scientist II, Molecular & Computational Biology

    Tonix Pharmaceutical 3.8company rating

    Drug safety scientist job in Frederick, MD

    About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit ******************* for specifics on the pipeline. * All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix Pharmaceuticals is seeking a highly motivated Associate Scientist to join our multidisciplinary R&D team at the Frederick Research & Development Center. This role integrates computational protein structure analysis with hands-on molecular biology and protein biochemistry. The successful candidate will contribute to host-directed therapeutic discovery, antiviral platforms, and vaccine design by combining AI/ML-based protein modeling with molecular biology and protein science to generate, express, and analyze protein targets. Key Responsibilities * Perform protein structure modeling and design using platforms such as AlphaFold2/3, ESM, RFdiffusion, ProteinMPNN, and NetMHC. * Build and refine bioinformatics workflows for large-scale sequence and structural analysis of host and viral proteins * Perform molecular cloning, PCR, DNA and RNA isolation, bacterial transformation, and mutagenesis to generate expression constructs. * Carry out protein expression and purification followed by protein characterization * Collaborate with Tonix's imaging and cell biology teams to translate computational predictions into testable hypotheses in assays and animal models. * Contribute to the development of user-friendly computational pipelines and visualization tools for internal scientists. * Document and communicate results in reports, regulatory filings, and presentations to internal teams, collaborators, and external partners. * Maintain awareness of emerging computational biology technologies to enhance Tonix's drug discovery capabilities. Required Qualifications * B.S. or M.S. in Microbiology, Biochemistry, Bioinformatics, Computational Biology, or related field. * Hands-on experience with protein structure prediction and computational protein design tools. * Familiarity with core molecular biology and protein biochemistry methods (PCR, cloning, bacterial expression, Western blotting). * Strong communication skills and ability to work in cross-functional teams within Tonix's integrated discovery pipeline. Preferred: * Experience with cloud computing platforms (Google Cloud, AWS) for large-scale protein modeling. * Exposure to machine learning approaches in protein design and immunology. * Prior experience with protein engineering for therapeutic applications. * Track record of contributions to publications, posters, or conference presentations. * Proficiency in Python, especially ML/AI packages. Experience in Linux operating systems and shell programming is desirable. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $60,000 to $90,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: * Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs * Pet Insurance * Retirement Savings 401k with company match and annual discretionary stock options * Generous Paid Time Off, Sick Time, & Paid Holidays * Career Development and Training Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
    $60k-90k yearly 55d ago

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