Vice President, Clinical Operations EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED Position Summary
The Vice President of Clinical Operations provides leadership and management to all aspects of the company?s clinical operations function worldwide. The incumbent will be responsible for all operational decision making, problem solving and strategic implementation of the programs.
Responsible for clinical trial execution including documentation of clinical trials, analysis and reporting to prepare documentation required for including in the company?s regulatory and legislative product approvals.
Responsible for development of clinical protocols to support the company?s product strategy, data collection and management and final reports development in compliance with appropriate standard operating procedures, regulatory and medical standards.
The position interacts with various groups within the company and external to the business to oversee clinical operations activities. This person will be responsible for the execution of global clinical trials in support of the products in development at EnVivo.
Successful candidate will be responsible for the organization, planning, and management of EnVivo staff and study oversight. They will also be responsible for planning the growth and integration of the Clinical Operations function into an evolving and maturing EnVivo. Staff recruitment, training, mentoring, work assignments, and performance evaluations will be the responsibility of this person in close collaboration with Development Team Leaders and the VP of Clinical Research.
Oversee CRO management and the production of clinical project plans and study designs. Maintain study budgets and assure that studies are carried out according to GCP and industry standards.
This position requires strong leadership skills based on a sound knowledge of clinical trials execution standards and drug development.
PharmD, PhD, or MS (or equivalent degree) with a minimum 10 plus years drug development experience.
Previous experience leading, designing and implementing global clinical development programs. Hands on experience in the execution of global clinical trial programs.
Familiarity with regulatory and quality guidelines (GCP).
Strong leadership skills with the ability to motivate and thrive in a changing and demanding environment.
Outstanding interpersonal skills and the ability to communicate effectively as a Team Player. Ability to reach out and develop collaborative working relationships with other functional areas within EnVivo.
Ability to foster a cooperative and effective work environment both internally and with external partners.
Able to work in a dynamic, rapidly growing small company environment.
Excellent oral and written communication skills.
Supervises all Clinical Operations functions in the Company, will have multiple reports at the Dir/SnDir level.
Reports to the CMO, Sen VP Drug Development
Participates in Development Management Leadership Team
||480 Arsenal Street |
Watertown, MA 02472
THIS JOB HAS EXPIRED