Clinical Research Physcian

Princeton, New Jersey
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 142133

Date Posted: 06/14/2019


Clinical Research Physician

Must Haves:

  • MD
  • Minimum 7 years of drug discovery and/or clinical development experience (at least as
    physician for 5 years) in pharmaceutical and/or biotech industry
  • Successfully led (as a compound lead physician) at least on NMC’s registration
    development
  • Experience in Oncology and autoimmune therapeutic areas

 

The Individual is responsible for products’ clinical development strategy and execution plans.
He/she is responsible for sound design, successful conduct, and accurate results
analysis/interpretation of clinical studies. He/she is responsible for providing clinical science
technical leadership to lower level physicians in the team

  • Independently drive the clinical development strategy and plan (including protocols)
    for projects
  • Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing
    medical monitoring)
  • Co-owners of clinical study delivery
  • Development documents (CIB, protocol and CSR, etc) content owner
  • Analyze and interpret clinical study results in partnership with Clinical Development
    functions;
  • Form and run advisory board meeting; Be responsible for interacting and communicating with KOLs for development strategy and protocol design
    Responsible for safety program-level assessment of safety information, evaluation of
    safety signals, regulatory compliance of safety reporting including updating safety
    profile in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.
  • Oversight of PK/PD programs via clinical pharmacologist to ensure the deliverables
    Set strategic direction for addressing medical issues in regulatory submission and
    communication/interaction
  • Be a lead physician co-leading the regulatory filing and registration
  • Be a lead physician leading discussions with regulatory officials on clinical science
    subjects of compounds
  • Be lead physician providing consultation to clinical operation colleagues on protocol
    design questions and answering protocol related questions from site investigators
  • Liaise with other functions to support pre-launch marketing activities, publications,
    conferences and early market access to the compounds
    Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences

Requirements

Medical Degree
Disease Knowledge
Patient journey
Treatment guidance
Compound knowledge
Regulatory guidance for the therapy area
Medical monitoring
Safety reporting and Risk Management Plan
CSP/CSR content & data analysis
Leadership skill

Minimum 7 years of drug discovery and/or clinical development experience (at least as
physician for 5 years) in pharmaceutical and/or biotech industry
Successfully led (as a compound lead physician) at least on NMC’s registration
development
Demonstrated leadership and administrative skills in project (and people) management
Big picture with ability to prioritize and focus with attentive to detail and excellent
analytical skills

Location:  Targeting Princeton Area


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