Senior Medical Director, Clinical Development Sciences
Location: Boston, MA
This is what you will do:
The Senior Medical Director, Clinical Development Sciences may lead the clinical subteam or support the clinical subteam and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings.
You will be responsible for: Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs.Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee).Supervise and develop Medical Directors and CDS and/or fellows; may lead a clinical subteam and oversee the preparation of a clinical development strategy.As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have: Board Certification Preferred.Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.5+ years of industry experience in clinical development is preferred.Experience for medical responsibilities on a cross-functional team preferred.Basic statistical knowledge preferred.Understanding of general (and specific) therapeutic principles.Experience designing and executing industry-sponsored clinical trials.Broad experience in the principles of clinical trial methodology, statistics, data analysis and interpretation.Expert in scientific literature searches and weighing of quality peer-reviewed data.Experience authoring study essential documents, Clinical Study Reports, and regulatory documents.Strong relevant therapeutic area experience.Ability to clearly communicate to internal and external stakeholders orally and in writing.Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end results.Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget.Ability to think both strategically and tactically.
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