Medical Director of Endocrine Clinical Development Senior Director

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