Clinical Affairs Consultant II

2 days ago


Cambridge, Massachusetts, United States ELYON International Full time
Clinical Affairs Consultant II

As a Clinical Affairs Consultant II at ELYON International, you will play a critical role in leading the development of evidence generation strategies for assigned projects. Working within a cross-functional team, you will ensure that studies yield well-founded conclusions and support the company's regulatory clearances, claims, epidemiology/surveillance, reimbursement, health economic outcomes, and/or market access.

Key Responsibilities:

  • Leading the development of evidence generation strategies for assigned projects
  • Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per internal and external requirements
  • Working closely together with internal and external stakeholders to ensure that studies yield well-founded conclusions
  • Design and development of study protocols in compliance with project standards, specifications, and applicable regulatory guidelines
  • Manage and oversee study execution, analysis of results, and generation of final study reports
  • Deliver assigned clinical programs, working in partnership with Clinical Operations
  • Lead the development and dissemination of evidence generated from clinical evaluation plans
  • Lead clinical evidence, epidemiology/surveillance discussions with regulators, advisory boards, associations, and societies
  • Keeping current with regulatory guidance and requirements in the global environment
  • Ensuring appropriate interpretation and dissemination of all evidence generated

Requirements:

  • MD, PhD/MS Degree in Biomedical science, Epidemiology strongly preferred
  • 7+ years' experience in clinical research/development/real-world evidence (RWE) function; medical devices preferred
  • Strong scientific background and deep expertise in the development of evidence generation and clinical evaluation/RWE and research methodologies
  • Experience in Machine Learning/Artificial Intelligence algorithm clinical performance validation
  • Deep understanding of global clinical evidence requirements, including regulatory paths, and deep knowledge and understanding of all applicable standards/regulations in clinical evidence generation and dissemination
  • Knowledge of RWE to support regulatory decisions
  • Strong ability to critically assess clinical literature
  • Excellent communication skills, including written communication and oral presentation of scientific materials and research results
  • Ability to work collaboratively with cross-functional partners, shape, and lead without direct reporting authority
  • Proven track record in successfully developing and executing clinical evidence strategies for regulatory submissions

Benefits:

  • Paid sick leave
  • Medical/Dental (optional)
  • 401(k) Retirement Plan (optional)
  • Employer Paid Life Insurance
  • Employer Paid Short Term Disability
  • Optional Life Insurance

ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



  • Cambridge, Massachusetts, United States SSi People Full time

    Clinical Affairs ConsultantWe are seeking a highly skilled Clinical Affairs Consultant to join our team at SSi People. As a Clinical Affairs Consultant, you will be responsible for developing and executing clinical evidence strategies for regulatory submissions, on-time within budget and in compliance with SOPs and regulations.Key Responsibilities:Develop...


  • Cambridge, Massachusetts, United States Insight Global Full time

    Clinical Affairs Specialist OpportunityThis role is a key member of the business team, responsible for leading the development of evidence generation strategies for assigned projects. The Clinical Affairs Specialist will work closely with internal and external stakeholders to ensure that studies yield well-founded conclusions.Key Responsibilities:Leading the...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Lifelancer is seeking a seasoned Regulatory Affairs professional to join our team as a Director/Senior Director, Regulatory Affairs. In this critical role, you will be responsible for developing and implementing global regulatory strategies for our development programs, ensuring compliance...


  • Cambridge, Massachusetts, United States Randstad Digital Full time

    Job SummaryAs a Regulatory Affairs Consultant Lead at Randstad Digital, you will play a critical role in driving a culture of patient safety and quality. You will represent and lead regulatory affairs on enterprise project teams, engaging in strategic discussions with business unit regulatory affairs leaders and specialists to efficiently and compliantly...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    About the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.Job DescriptionThe Director/Senior Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy....


  • Cambridge, Massachusetts, United States Cambridge Health Alliance Full time

    Clinical Specialist II Job DescriptionCambridge Health Alliance (CHA) is seeking a full-time Clinical Specialist II, Nurse Practitioner, to join our CHA PACE Program. CHA PACE is a Program of All-Inclusive Care for the Elderly (PACE) at Cambridge Health Alliance (CHA). Our team works to fully integrate and coordinate medical and behavioral health care,...


  • Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    Associate Director Regulatory Affairs CMC Job DescriptionWe are seeking an experienced Associate Director Regulatory Affairs CMC to join our team at PSG Global Solutions Careers. As a key member of our regulatory affairs team, you will be responsible for developing and executing global regulatory CMC strategies for assigned programs.Key Responsibilities:Lead...


  • Cambridge, Massachusetts, United States ONO PHARMA USA Full time

    About the RoleWe are seeking a highly skilled Senior Manager, Medical Excellence to join our team at ONO PHARMA USA. This is a key leadership position that will play a critical role in designing and developing the US Medical Affairs capability strategy and execution.Key ResponsibilitiesDrive medical excellence of US Medical Affairs members for both Head...


  • Cambridge, Massachusetts, United States Cambridge Health Alliance Full time

    Clinical Specialist II Job DescriptionCambridge Health Alliance (CHA) is seeking a skilled Clinical Specialist II to join our CHA PACE Program. As a key member of our interdisciplinary team, you will play a vital role in providing high-quality healthcare services to adults 55 years and older with chronic medical and/or mental health difficulties.Key...


  • Cambridge, Massachusetts, United States AbbVie Full time

    Job SummaryAbbVie is seeking a highly skilled Medical Director or Scientific Director to join our Medical Affairs team. As a key member of our team, you will be responsible for providing strategic medical and scientific input into core medical affairs activities, including healthcare professional/provider interactions, generation of clinical and scientific...


  • Cambridge, Massachusetts, United States Cambridge Health Alliance Full time

    Clinical Specialist II - PACE ProgramCambridge Health Alliance (CHA) is seeking a full-time Clinical Specialist II, Nurse Practitioner, to join our CHA PACE Program. CHA PACE is a Program of All-Inclusive Care for the Elderly (PACE) at Cambridge Health Alliance (CHA). Our team serves adults 55 years and older with chronic medical and/or mental health...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Cullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    At Agios Pharmaceuticals, we're seeking a skilled Regulatory Affairs Strategist to join our growing Regulatory team.This individual will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.The successful candidate will prepare and oversee the...


  • Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    Associate Director of Regulatory Affairs Job DescriptionAt PSG Global Solutions Careers, we're seeking a highly skilled Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market.Develop and...


  • Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full time

    Job Title: Associate Director, Regulatory Affairs CMCVoyager Therapeutics, Inc. is seeking an experienced Associate Director to lead our Regulatory Affairs CMC team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing global Regulatory CMC strategies to secure approval of our gene therapy products.Key...


  • Cambridge, Massachusetts, United States Vedanta Biosciences Full time

    Job Title: Senior Manager/Associate DirectorJoin Vedanta Biosciences, a late-stage biopharmaceutical company, as a Senior Manager/Associate Director in our Medical Affairs team. We are seeking an experienced field-based scientific and clinical professional to support our medical affairs and therapeutic development objectives in the assigned geographic...


  • Cambridge, Massachusetts, United States Philips Full time

    Job Title: Principal Ultrasound Regulatory Affairs SpecialistAt Philips, we are seeking a highly skilled Principal Ultrasound Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our ultrasound devices with global regulatory requirements.Key...


  • Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Job Title: Director, Global Regulatory AffairsGlaxoSmithKline is seeking a highly skilled and experienced Director, Global Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and leadership on regulatory matters related to our RNA vaccines.Key...


  • Cambridge, Massachusetts, United States Thymmune Therapeutics Full time

    Job OverviewThymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.We are seeking a highly skilled and experienced Head of Regulatory...


  • Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full time

    Job DescriptionBicycle Therapeutics Limited is seeking a highly skilled Senior Director, Global Medical Affairs Strategy to join our team. As a key member of the Medical Affairs leadership team, you will be responsible for developing and executing the overall global medical affairs strategy and tactical plans for our current and future portfolio.This role...