layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Medical Director, Clinical Development Endocrinology - Job ID: 2048 at Ascendis Pharma

As the clinical lead of a therapeutic area within endocrinology, responsible for the formulation and implementation of the Clinical Development Plan
Represent clinical development on the Project Core Team
Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program
Provide leadership to study teams
For clinical trials: design, provide overall oversight, and support site and subject retention
Serve as a medical monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy data
Provide leadership to teams of medical monitors: oversee all aspects of the clinical monitoring process in accordance with ICH GCPs and global SOPs to assess the safety and efficacy of investigational products
Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
Analyze, evaluate, interpret, and report clinical data
Anticipate and solve complex drug development problems
Contribute to regulatory strategy
Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions
Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
Collaborate with—and serve as a clinical research resource for—cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development
Represent the clinical development department in corporate strategic and organizational initiatives
Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
Assist in portfolio management and commercial activities as needed
Complete assigned tasks thoroughly, accurately, and on time
Adhere to rigorous ethical standards
Travel up to 20% domestically and internationally for scientific meetings

Senior Medical Director, Clinical Development Endocrinology - Job ID: 2048

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