Job Description

Job Number: 21-04032

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Physician for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:
  • Lead for aggregate safety reports and strategic documents, e.g., safety aggregate reports and risk management plans
  • Serves as a primary source of medical accountability and oversight for clinical trials
  • Matrix management responsibilities across the internal and external network
  • Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities
  • Provides medical and scientific expertise to cross-functional Client colleagues
  • Medical Monitoring
  • Contributes to and is a key member of a high performing Delivery Team (and may be a member of the Development Team
  • Conducts medical data review of trial data, including eligibility review
  • Holds responsibility for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
  • Holds responsibility for assessment of key safety-related serious adverse events in partnership with Patient Safety and oversees safety narratives
  • Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
  • Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
  •  Clinical  Expertise & Strategy:
    • In collaboration with the Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
    • Provides oversight and medical accountability for a group of studies
    • Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
    • Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
    • Identifies and builds relationships with principal investigators.
    • Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
    • Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder.
    • Keeps up-to-date in the disease area by attending scientific conferences and ongoing review of the literature
    • Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
    • Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others
  • Health Authority Interactions & Publications:
    • Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
    • Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists
  • Primary role: Medical safety lead for aggregate safety reports and strategic documents
  • Supports and/or Chairs Medical  Teams in overseeing and conducting safety data analysis
  • Capable of reviewing data to perform Signal Detection/Safety surveillance; can evaluate and integrate data from multiple sources, including clinical, nonclinical and real-world, to understand and manage safety signals
  • Plans risk strategy, risk assessment, and risk minimization for Client products in partnership with other Client functions
  • Serves as safety consultant for product development activities.
  • Leader or key contributor to safety query responses.
  • Medical competency and scientific analytic skills
  • Key Stakeholders/Contacts:
  • Internal Matrix: Safety Scientist, Scientific Writer, Epidemiologist, Clinical Safety Program Lead, Medical Review Safety Physician, Therapeutic Area Head, Administrative Assistants
  • MD or Equivalent.
  • Has completed a Board certification and/or relevant higher medical training.
  • Generally, has 3 or more years previous experience as medical safety assessment physician; recent experience preparing safety aggregate reports (eg, PBRER, DSUR)
  • Skills:
    • Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity
    • Strong written and oral scientific communication skills
    • Strong scientific analytical reasoning skills
    • Behavioral competencies necessary to work and lead within a complex matrix environment
    • Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
    • Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
    • Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
    • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
John Bayog
John Bayog | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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