Medical Director of Endocrine Clinical Development Senior Director

Location
Palo Alto, California
Salary
Competitive
Posted
26 Jan 2021
Closes
25 Feb 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

Key Responsibilities

  • Lead the clinical TransCon CNP program and support clinical operations activities
  • Support the CEO, SVP Endocrinology Medical Sciences and Project Director
  • Effectively manages key opinion leaders and other stakeholders
  • Organizes and oversees Clinical Advisory Boards
  • Assists in portfolio management and supports commercial activities as needed
  • Maintains up to date knowledge on all clinical data relevant to the client's programs, the competitive landscape, GCPs and clinical trial information
  • Participates in professional and industry organizations to follow clinical trends, meets with KOLs, participates in patient support group meetings and develops relationships to represent the interests of the Company.
  • Supports recruitment, monitoring and completion of clinical trials
  • Authors study synopses, protocols.
  • Collaborates with Clinical Operations in maintaining study tracking tools and status reports.
  • Participates in core teams and leads clinical project team meetings. Maintains contact with study sites for issues, resolution and regulatory documentation.
  • Assists with development of CRFs
  • Assists in review of clinical safety reports from investigator sites and overall clinical trial safety data
  • Represents the client's Clinical Development in regulatory interactions related to assigned development programs
  • Assists in other regulatory submissions as appropriate
  • Represents Clinical Development in submission planning meetings
  • Provides training and advice to Clinical Operations and other functional group stakeholders on endocrine physiology and disorders
  • May assist with coordination of non-routine projects as needed
  • Collaborates with cross-functional peers to facilitate and optimize the product development and registration process
  • Stays abreast of new medical information, regulations and regulatory guidance as well as clinical publications, articles and abstracts to promptly identify possible impact, competition or improvements to product programs.

Requirements

  • MD degree, with specialization in pediatric endocrinology required.
  • At least 5 years (Director) to 10 years (Sr Director) of industry and academic experience including scientific training at MD level or equivalent
  • At least 5 – 10 years’ experience with clinical trial design and execution
  • Excellent understanding of the drug development process and GCPs
  • Very strong clinical/scientific background and aptitude
  • Strong writing and presentation skills
  • Ability to follow complex direction/processes under pressure
  • Very strong organizational skills, attention to detail, and ability to consistently meet high standards vital in a highly regulated environment
  • Proficient in balancing multiple tasks simultaneously to achieve goals
  • Works well under general direction and may independently determine and develop approaches to non-routine problems
  • Open-minded and dedicated team player who thrives in a dynamic and international environment of continuous development, with attention to high quality, high ambitions and results

Benefits

  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Commuter benefits
  • Disability insurance