Senior Director Endocrine Clinical Development

Employer
Ascendis Pharma
Location
Palo Alto, California
Posted
Nov 18, 2020
Closes
Nov 18, 2021
Ref
2064034
Specialty
Endocrinology
Hours
Full Time
Position Type
Permanent

Description

Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to supporting your professional development on our journey.

Ascendis Pharma is looking to hire an experienced Senior Director Endocrine Clinical Development to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!

Position Summary

As a leader within Clinical Development and as a member of the Project Core Team, the Senior Director Endocrine Clinical Development will perform clinical development activities associated with drug development. This individual will be responsible for the clinical development plan, synopsis and protocol writing and review, study monitoring, safety review and clinical strategy supporting the project strategy. Responsibilities include supporting preparation for, and participation in, regulatory interactions and preparing regulatory submissions. The individual will be the clinical lead for Phase 2 and Phase 3 studies within the assigned development program.

The Senior Director of Endocrinology Clinical Development performs, coordinates and oversees all aspects of the clinical monitoring process in accordance with ICH GCPs and global SOPs to assess the safety and efficacy of investigational products. She/he will work with Clinical Operations, Biometrics and Regulatory Affairs to conduct independent monitoring of sites to determine adherence to protocol, applying knowledge of FDA regulations to ensure regulatory compliance. She/he will assist the SVP, Endocrinology Medical Sciences, working with the VP, Clinical Operations and Clinical Trial Manager, to coordinate activities of the CRO and investigators, and perform medical monitoring.

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 Ascendis 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 Ascendis 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 preferred
  • 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

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