Clinical Study Management

  • location: Cambridge, MA
  • type: Contract
  • salary: $125 - $134.75 per hour

job description

Clinical Study Management

Job Title: Medical Director- Pediatric Oncology

Position Description

  • Medical Director-Pediatric Oncology leads and drives strategy for the overall pediatric clinical development of assigned Company pipeline compounds, taking into consideration the medical, scientific, regulatory and commercial issues. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility for contributing to development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global pediatric investigation and development plan. Applies clinical/medical decision making to clinical development issues.
Position Responsibilities

  • Clinical Development team participation and leadership

    • Provides leadership to pediatric clinical development to ensure that activities are aligned with the global strategy.
    • Establishes and drives strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols for pediatric development. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
  • Synopsis / Protocol Development, Study Execution, & Study Interpretation

    • Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.
    • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
  • Trial Medical Monitoring

    • Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
    • Makes final decisions regarding study conduct related to scientific integrity.
  • External Interactions

    • Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders and cooperative groups relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.
Position Requirements

  • MD or internationally recognized equivalent with training in pediatric oncology plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
  • Previous experience successfully creating and implementing a pediatric clinical development plan
  • Skills

    • Superior communication, strategic, interpersonal and negotiating skills
    • Ability to proactively predict issues and solve problems
    • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
    • Diplomacy and positive influencing abilities
  • Knowledge

    • Therapeutic area knowledge relevant to mechanism of action
    • Regional/global Regulatory requirements
    • GCP/ICH
    • Emerging research in designated therapeutic area
  • Travel Requirements

    • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
    • Requires approximately 15 - 25% travel.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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