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Job

Director of Clinical Development (Oncology)

  • Location

    San Francisco Bay Area

  • 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:

    26 days ago

  • Expiry date:

    2019-12-16

  • Startdate:

    ASAP

Responsibilities:

The Director of Clinical Development, Oncology will be responsible for overseeing the development and management of Clinical Development Plans, including timelines, budget and resource requirements.

 

Core responsibilities include:

  • Design and implement clinical program strategy and direct those systems and programs to meet Company goals and objectives.
  • Develop and chair the Medical Advisory Board for proprietary products.
  • Participate in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
  • Direct the design of pivotal clinical studies for product and registration.
  • Identify and develops collaborations with external investigators and opinion leaders.
  • Responsible for interfacing with cross-departmental groups including Clinical Research, Data Management ,Regulatory Affairs, Clinical Operations, Marketing and Business Development.
  • Serve as a key clinical opinion leader working with physicians at a peer level.
  • Direct and coordinate efforts to address medical and scientific issues.
  • Work closely with Data Management and Biostatics to provide clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products.
  • Provide support to the business in the review of promotional materials and the training of product representatives.
  • Perform medical monitoring.
  • Support 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.
  • Apply this knowledge to current programs.
  • May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.

Requirements:

 

  • MD degree is required, Board Certification in oncology is a plus
  • 7+ years relevant clinical science/medical affairs experience is required
  • Extensive experience in the design of clinical studies in oncology.
  • 5+ years previous management experience
  • Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
  • Strong knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry.
  • Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
  • Experience and understanding of ICH, and GCP is required, knowledge of GMP and GLP is preferred.