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Clinical Research Director

Waltham MA, Bridgewater NJ
Job Order: GD-701

Job Descriptions:

 

  • The Clinical Research Director (CRD), Rare Blood Disorders Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects in this Therapeutic Area (TA). 
  • The CRD is expected to contribute to the growth of the Rare Blood Disorders TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging “the status quo”.
  • Has and maintains deep scientific, technical and clinical expertise in the therapeutic area
  • Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
  • Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
  • Maintains visibility within the Therapy therapeutic area to maintain credibility with internal and external stakeholders
  • Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes
  • Assessment of the Clinical benefit –risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team
  • Provides clinical input to the Target Product Profile
  • Adjusts and updates the clinical strategy when necessary according to the project progression and information available
  • Contributes to the life cycle management strategy for the project whenever appropriate
  • Generates the Clinical Development Plan
  • Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies
  • Generates the extended synopsis for clinical trials and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)
  • Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist
  • Reviews and when appropriate approves the committees charters
  • Prepares with the support of the medical writing department the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provide input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety…) and other sections whenever appropriate
  • Prepares answers to questions from Regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate
  • In charge of the medical/clinical assessment of license-in opportunities
  • Reviews the Statistical Analysis Plans
  • For study protocols and Clinical Trial Authorization dossier, writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees
  • When appropriate collaborates with the CSD in preparing material for investigators meetings and in answering questions from investigators
  • Reviews the list of countries for clinical studies
  • Reviews Key Results Memos and Clinical Study Reports
  • Provide clinical input to and reviews the Risk Management Plan
  • Reviews scientific publications and communications on the project
  • Prepares and provides key medical information to internal people and external people

 

Job Requirements:

  • MD required
  • More than 5 years of clinical or scientific, or more than 10 years industry, experience within the field
  • Strong scientific and academic background with deep understanding of disease
  • Clinical research or pharmaceutical experience in the therapeutic area preferred
  • Knowledge of drug development preferred
  • Good networking ability in cross-cultural environment
  • Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization. Performance oriented and focus on strategy and execution
  • Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills
  • Fluent in English (verbal and written communication)

 

DATE POSTED 2019-08-15

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