Senior Medical Director Endocrine Clinical Development

Location
Palo Alto, California
Salary
Competitive
Posted
25 Jan 2021
Closes
24 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