Current jobs related to Scientific Affairs Director - Rockville, Maryland - Meso Scale Diagnostics LLC


  • Rockville, Maryland, United States GSK Full time

    Director, Global Regulatory Affairs - RNA VaccinesLead Regulatory Strategy for RNA VaccinesGSK is seeking a highly skilled Director, Global Regulatory Affairs to lead the regulatory strategy for our RNA vaccines portfolio. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory plans to ensure compliance...


  • Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Title: Regulatory Affairs DirectorAt GlaxoSmithKline, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory strategy.Key...


  • Rockville, Maryland, United States GSK Full time

    Job Title: Global Regulatory Affairs DirectorAt GSK, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Global Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory...


  • Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...


  • Rockville, Maryland, United States Arcellx, Inc. Full time

    About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Job SummaryWe are seeking an...


  • Rockville, Maryland, United States MaxCyte Full time

    Job Title: Director, Regulatory AffairsMaxCyte is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs while ensuring safety, quality, and regulatory compliance.Key Responsibilities:Develop and implement regulatory compliance strategies to maintain...


  • Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs, safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies and plans to ensure...


  • Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...


  • Rockville, Maryland, United States MaxCyte Inc Full time

    Job Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs, safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance and strategies to ensure...


  • Rockville, Maryland, United States Arcellx, Inc. Full time

    About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Our TeamOur team members are...


  • Rockville, Maryland, United States AMERICAN SOCIETY OF HUMAN GENETICS Full time

    Job Title: Senior Director, Strategic Content and Scientific ProgramsJoin the American Society of Human Genetics (ASHG) as a Senior Director, Strategic Content and Scientific Programs, and play a key role in shaping the organization's scientific, digital, and leadership and professional development programming. This is an exciting opportunity to drive...


  • Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Purpose:As an Associate Director, Global Regulatory Affairs, you will be responsible for developing and executing global and/or regional regulatory strategies for assigned assets, across all stages of the product life cycle. This role requires ensuring compliance with internal GSK processes and policies, as well as relevant regulatory requirements, to...


  • Rockville, Maryland, United States Proclinical Staffing Full time

    Lead Regulatory Affairs for Innovative Biotech PortfolioProclinical Staffing is seeking a seasoned Regulatory Affairs professional to spearhead strategic regulatory decisions for a cutting-edge biotech portfolio.This key role will be responsible for guiding global regulatory pathways, overseeing a growing team, and reporting directly to the c-suite. The...


  • Rockville, Maryland, United States MaxCyte Inc Full time

    The Director, Regulatory Affairs will lead the Regulatory function at MaxCyte. The successful candidate will develop and implement regulatory compliance and strategies that enable MaxCyte to meet business needs, as well as safety, quality, and regulatory requirements.Key Responsibilities:Interpret and implement regulatory requirements and regulations to...


  • Rockville, Maryland, United States Proclinical Staffing Full time

    Head of Regulatory AffairsProclinical Staffing is seeking a seasoned professional to lead strategic regulatory decisions for an innovative biotech portfolio.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with FDA and global regulations.Lead a growing team of regulatory professionals and provide guidance on regulatory...


  • Rockville, Maryland, United States AMERICAN SOCIETY OF HUMAN GENETICS Full time

    Job DescriptionJob SummaryThe American Society of Human Genetics seeks a highly skilled and experienced Senior Director, Strategic Content and Scientific Programs to lead the development and implementation of innovative scientific, digital, and leadership programs that align with the Society's strategic goals. This role will focus on designing, growing, and...


  • Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Title: Associate Director, Influenza, US Region, Regulatory AffairsAre you a seasoned regulatory affairs professional looking for a challenging role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager position could be an ideal opportunity to explore.About the...


  • Rockville, Maryland, United States National Institutes of Health Full time

    Job SummaryThe National Institutes of Health (NIH) is seeking a highly qualified individual to serve as the Associate Director for the Cancer Imaging Program (CIP) within the Division of Cancer Treatment and Diagnosis (DCTD). This is a full-time government position in Rockville, Maryland.The successful candidate will be responsible for leading the CIP, which...


  • Rockville, Maryland, United States Psomagen Inc Full time

    Job DescriptionClinical Applications Scientific Product ManagerJob SummaryPsomagen Inc. is a leading CLIA-certified laboratory specializing in Next-Generation Sequencing (NGS) based high complexity tests. We are seeking a highly skilled and experienced Clinical Applications Scientific Product Manager to join our team.Key ResponsibilitiesLead the clinical NGS...


  • Rockville, Maryland, United States Otsuka Pharmaceutical Co., Ltd. Full time

    Job SummaryThe Associate Director, Drug Substance, Pharmaceutical Development will lead process development and optimization of drug substances and will manage manufacturing activities for API, intermediate, and RSMs for assigned projects. The Associate Director, Drug Substance, Pharmaceutical Development will assist with the preparation and review of drug...

Scientific Affairs Director

2 months ago


Rockville, Maryland, United States Meso Scale Diagnostics LLC Full time
Job Summary

This position is responsible for collaborating with the commercial team to identify revenue-producing opportunities within Meso Scale Diagnostics LLC's customer base. The incumbent will have an intimate understanding of the drug discovery process combined with strong scientific knowledge regarding the utility of biomarker measurements.

Key Responsibilities
  1. Initiate frequent interactions with customers and collaborate with the sales and field application support teams on strategies to identify customer needs and provide guidance on how to maximize the use of Meso Scale Diagnostics LLC's product offering.
  2. Collaborate with assay services sales team on strategies to expand the assay services business.
  3. Identify and foster external collaborations with key opinion leaders and corporate partnerships in biotechnology, personalized medicine, the drug/pharmaceutical industry, and diagnostics.
  4. Identify and foster relationships with key decision makers in academia, non-profits, consortia, and government.
  5. Promote Meso Scale Diagnostics LLC's reputation as a biomarker leader and enabler for the scientific community.
  6. Act as Meso Scale Diagnostics LLC spokesperson at conferences to deliver key information about Meso Scale Diagnostics LLC products and services. Host internal and external seminars/webinars, as needed.
  7. Generate content to advertise Meso Scale Diagnostics LLC's expertise, including presentations, web content, blogs, editorials, etc. Ensure content is current on literature, webinars, conferences, and pharma/clinical business news.
  8. Understand and communicate a narrative that Meso Scale Diagnostics LLC's products and services can impact customer research and drug development activities.
  9. Keep abreast of scientific and competitor advancements in the marketplace. Share expertise and best practices with internal clients, peers, and others across the company as appropriate.
  10. Gather and compile information about the unmet needs for biomarker measurements and determine strategies for Meso Scale Diagnostics LLC to develop products/services to address them.
  11. Ensure all activities are logged in Meso Scale Diagnostics LLC's database of customer information.
  12. Specific duties may vary depending upon departmental requirements.
Requirements
  1. Advanced degree (PhD, MD, MD/PhD, Pharm. D.) in a biological sciences discipline.
  2. Minimum of 10 years of experience in pharma or biotech, leading drug development projects.
Preferred Qualifications
  1. Comprehensive understanding of the pharma industry and its current and future needs.
  2. Thorough understanding of the principles of biomolecule detection assays, their development, and their applicability in different research fields. Superior competency in scientific fundamentals.
  3. Superior communication (written and verbal) skills with the ability to translate information into a meaningful, understandable context and message, regardless of the format (e.g., documents, public speaking situations, presentations, etc.).
  4. Strong business acumen, negotiation, and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes. Ability to build/foster relationships.
  5. Demonstrated propensity to be creative, collaborative, proactive, and self-motivated in the execution and completion of assigned accountabilities.
  6. Attention to detail with a demonstrated commitment to excellence and performance improvement and the drive to deliver quality and value-added results and outcomes.
  7. A professional presence and strong interpersonal skills for interacting in a courteous, timely, and diplomatic manner with all levels of employees as well as external parties.
  8. Excellent organizational, planning, and time management skills.
  9. Ability to travel with some overnight stays.
  10. Proficiency in MS Office Suite.