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Job

Senior Director, Clinical Development (Oncology - MD)

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive Salary and Bonus

  • Contact:

    Danielle Granholm

  • Contact email:

    d.granholm@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    29 days ago

  • Expiry date:

    2019-12-19

  • Startdate:

    ASAP

The Sr. Director, Clinical Development - Oncology (MD) oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities.

Essential Requirements:

  • MD degree is required, Board Certification in oncology or related field is a plus.
  • 9+ years relevant clinical science/medical affairs experience in oncology is required
  • Extensive experience in clinical study design in oncology is required
  • 7+ years previous management experience may be required.
  • Strong ability and desire to solve problems with innovative solutions along with strong organizational skills.
  • Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
  • Extensive experience and understanding of ICH, and GCP is required, knowledge of GMP and GLP is preferred.

 

Core responsibilities include:

  • Create and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
  • Recruit clinical investigators and negotiate study design and costs
  • Oversee human clinical trials, phases I-IV for company products under development
  • Responsibilities also include adverse event reporting and safety responsibilities monitoring.
  • Coordinate and develop reporting information for reports submitted to the FDA.
  • Ensure adherence to protocols and determine study completion.
  • Act as consultant/liaison with other corporations when working under licensing agreements.
  • Select, develop, and evaluate personnel to ensure the efficient operation of the function.
  • Collaborate on abstract problems across functional areas of clinical development and medical affairs.
  • Identify and evaluate fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products.
  • Interact internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies.
  • Oversee the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements.
  • Ensure development and implementation of clinical program strategy and direct those systems and programs to meet Company goals and objectives.
  • Create and chair the Medical Advisory Board for proprietary products.
  • Oversee the design of pivotal clinical studies for product and registration.
  • Identify and develop collaborations with external investigators and opinion leaders.
  • Collaborate with cross-departmental teams as, Clinical Research, Regulatory Affairs, Clinical Operations, Marketing and Business Development.
  • Act as a clinical opinion leader working with physicians at a peer level.
  • Oversee and coordinate efforts to address medical and scientific issues.
  • Provide clinical analysis, scientific and clinical support for expansion of market share of Company products.
  • Provide guidance to the business in the development of promotional materials and the training of product representatives.
  • Oversee and perform medical monitoring.
  • Drive the development of publications arising from studies and other relevant initiatives.
  • Act as a mentor to junior staff.
  • Remain current with medical developments and publications on similar and competitor products.
  • May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.