Job Opportunities

 

Posted 12/26/2019

Clinical Trial Lead – Auto Injection Drug Device (Central NJ) (Onsite Only)

Responsibilities

  • Work with the Program Lead or Senior Clinical Lead, and team members to translate the FDT strategy into protocols
  • Management of one or more uncomplicated clinical monitoring studies and preparation of regulatory documents
  • Data review and cleaning of ongoing studies
  • Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions
  • Identify and builds relationships with investigators
  • Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
  • Responsible for the study timelines in a cross-functional matrix protocol team
  • Responsible for the clinical development activities from site(s) initiation to study discontinuation
  • Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements
  • Designs and implements safety monitoring plans
  • Interprets clinical data and makes appropriate decisions and recommendations to the Program Working Team sub team
  • Identify and build relationships with principal investigators
  • Identify Thought Leaders and use them for inputs in clinical strategy and protocol design
  • Maintain a strong medical/scientific reputation within the disease area
  • Contribute to Health Authority interactions as a Medical Monitor on assigned clinical studies
  • Share specific clinical strategies with other clinical teams
  • Study-specific clinical design and execution

Qualifications

  • MD; PhD or Pharm D
  • Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry – e.g. monitoring)
  • Management of one or more uncomplicated studies and preparation of regulatory documents
  • Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock
  • Has a history of handling multiple, complex, studies in parallel
  • Has a history of prior meaningful participation in regulatory submissions
  • Has a history of strong interaction with thought leaders
  • Proven team leadership capability
  • Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry – e.g. monitoring)

If interested, send an email with your CV for a confidential review to nk@premierpharma.net. It is our company policy never to share a Candidate’s CV to our Client’s without prior approval of the Candidate.

Premier Pharma Executive Talent Sourcing is a national executive recruiting firm focused exclusively on the pharmaceutical and biotech industries. We specialize in placing talented candidates in Associate Director and above level positions, both permanent and contractor, in therapeutic areas such as oncology, hematology, immunology, cardiovascular, infectious disease, rheumatology, respiratory, endocrinology, CNS and more.  We also focus on relevant industry disciplines including clinical pharmacology, translational medicine, medical affairs, safety, and regulatory affairs. Premier’s highly skilled executive recruiters and researchers source for a broad range of positions for our Clients located across the United States. 

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Posted 11-27-2019

Laboratory Technologist- Flow Cytometry (Diagnostic Immunology Lab)

Columbus, Ohio

https://external-nationwidechildrens.icims.com/jobs/21070/laboratory-technologist–flow-cytometry-%28diagnostic-immunology-lab%29/job

 

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Posted 11-19-2019

Director, Antibody Immunology Laboratory
Rochester, MN 

“Heal the sick, advance the science, share the knowledge”

You are invited to partner with the nation’s best hospital (U.S. News & World Report 2019-2020), ranked #1 in more specialties than any other care provider. Practicing at Mayo Clinic provides a rewarding career that promotes excellence in patient-centered care. You can thrive in an environment that supports innovation and has a wealth of resources available to you – including an integrated EMR and collaboration with top specialists – to give your patients the quality of care you want to achieve.

The Division of Clinical Biochemistry & Immunology of the Department of Laboratory Medicine & Pathology at Mayo Clinic, Rochester, MN is recruiting a full time director for the Antibody Immunology Laboratory. The Department of Laboratory Medicine and Pathology is recognized as a world leader in cutting-edge diagnostic test development, clinical practice and education.

The ideal candidate should have a PhD (immunology or related discipline), MD, or MD/PhD, and be board-certified or board-eligible in medical laboratory immunology ABMLI, ABB High Complexity Clinical Laboratory Director Exam with Diagnostic Immunology component, clinical chemistry ABCC, or clinical pathology (with a strong background and experience in clinical immunology), to serve as a clinical laboratory director. Individuals who have completed a clinical laboratory immunology, or a clinical chemistry or clinical pathology fellowship with a focus in diagnostic laboratory immunology, are preferred. Board-eligible candidates must be qualified to take and pass their board exam within one year of accepting the position. Candidates must be eligible for a Certificate of Qualification by the New York State Department of Health in the category of “Diagnostic Immunology”.

Experience with autoantibody serology testing, including immunofluorescence assays, enzyme immunoassays, multiplex immunoassays, and chemiluminescent immunoassays, is required, as is familiarity with CLIA requirements and laboratory regulations and authorities. Candidates should be able to communicate effectively with laboratory staff, peers, and trainees, troubleshoot technical issues as they arise, and guide progress toward process improvements and optimal support of patient care. The job entails significant interaction with clinical colleagues, especially with the rheumatology, gastroenterology, and hematology practices, and providing clinical/diagnostic consultative support; therefore, a strong knowledge of clinical immunology/medicine would be advantageous.

The anticipated primary responsibilities of the position include: 1) Provide consultation and education regarding test utilization and interpretation to physicians and other providers, 2) Oversee development of new diagnostic tests and improve existing assays, 3) Provide laboratory oversight to ensure and enhance quality of service, 4) Work directly with physicians and clinical staff of Mayo Clinic and Mayo Clinic Laboratories to ensure service adequacy and address future needs, 5) Participate actively in Mayo Clinic education programs, and 6) Support Mayo Clinic research activities.

The incumbent will be an individual actively engaged in teaching and scholarship (defined as publications and lectureships), and will also foster and encourage collaboration with other divisions in the Department, including Mayo Clinic Laboratories, a global esoteric reference laboratory.

Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.

CLICK HERE to apply online.

Learn and grow among the best in your field at the nation’s top hospital (U.S.News & World Report,2019-2020), ranked No. 1 in more specialties than any other care provider. At Mayo Clinic, you’ll use the power of collaboration to achieve the highest standards for medical care and health improvement, working in the largest integrated, not-for-profit medical group practice in the world with over 60,000 employees. You’re invited to contribute to a unique environment that brings together the best in patient care, groundbreaking research and innovative medical education. Being a part of Mayo Clinic allows for more work-life balance, competitive compensation and generous benefits, career security and the ability to manage and coordinate patient care in the most efficient ways possible.

©2019 Mayo Foundation for Medical Education and Research. Post offer/pre-employment drug screening is required. Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities).