Vice President, Clinical Science - Boulder, CO | Biospace
Get Our FREE Industry eNewsletter

Vice President, Clinical Science

miRagen Therapeuitcs

Location:
Boulder, CO
Posted Date:
8/3/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Clinical Operations, Clinical Scientist, MD, Medical Affairs, Medical Director, Medical Science Liaison,

Job Description

The Vice President of Clinical Science will be a key member of the Leadership Team and responsible for contributing to the strategic direction and execution of the company’s clinical development programs across designated therapeutic areas. To perform this job successfully, the incumbent must be able to accomplish the following essential duties and responsibilities:

•   Be the principle architect in conjunction with the project team leader in the formulation and implementation of clinical translational strategies and integrated development plans across designated therapeutic areas.
•   Be the co-leader of a cross-functional project team(s) responsible for direction of the transition process from compound selection through progression into first in human, proof-of-concept clinical trials and later phase II/III studies.
•   Be the sole leader of the clinical/regulatory sub-team providing leadership and guidance to team participants for the creation, implementation and continued maintenance of all clinical trials related to designated areas of responsibility
•   Contribute to the clinical aspects of regulatory strategies and interactions with Health Authorities.
•   Initiate and maintain relationships with key opinion leaders, clinical investigators, cooperative groups, relevant lay organizations and other clinical stakeholders in regard to development of clinical strategies as well as design and enablement of clinical trials.
•   Lead in the analysis, interpretation, documentation and reporting of clinical trial data and results.
•   Lead in the analysis and interpretation of all safety signals related to designated areas of responsibility
•   Provide clinical support to the management team in its communications with the Board of Directors, investors, and potential business partners.

Requirements

•   MD with Board Certification, preferably in Internal Medicine.
•   8-10 years minimum pharmaceutical and/or biotechnology industry experience.
•   Management experience within a matrix organization for drug development
•   A proven success record in clinical research studies and trial design as well as the successful submission of IND’s and CTA’s.

Other Required Knowledge, Skills and Abilities:

•   Knowledge of relevant FDA regulations and guidelines; experience in interactions with FDA personnel; knowledge of EU or other health authority regulations and guidelines a plus.
•   Experience with or strong knowledge of oligonucleotide drug development a plus.
•   Experience in translational medicine, clinical pharmacology and early stage development.
•   Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
•   Possess excellent communication skills and the ability to articulate the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, and Company employees.
•   Must possess high personal values and ethical standards.