VP, Clinical Operations and Project Management

Location
94080, South San Francisco
Posted
Apr 25, 2019
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

POSITION SUMMARY:
The Vice President of Clinical Operations and Project Management is accountable for the leadership, strategic planning, oversight, execution of clinical programs and the management of staff responsible for multiple therapeutic areas and projects.  

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•    Oversight, management and guidance of Ph 1 – Ph III clinical programs for Rigel to ensure quality, timeline and budget goals are met
•    Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas within Rigel; Interact and collaborate with other department heads as appropriate. May present Clinical Operation updates to the executive team
•    Responsible for the strategic resource management of in-source/out-source study requirements
•    Evaluate and select service providers and manage these resources effectively
•    Supervise and guide project management activities
•    Manage and lead a team of ~ 9 employees
•    Travel as required by business needs
 

KNOWLEDGE AND SKILL REQUIREMENTS:  
•    Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferable
•    15 years of clinical trial experience at a pharmaceutical, biotechnology or CRO Company plus 10 years experience in significant management role
•    Ability to effectively manage multiple projects concurrently
•    Experience managing a rapidly changing organization and integrating new personnel is essential, as well as, ability to evaluate and resolve complex problems
•    Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff
•    Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical affairs trials, clinical study design, and data management methods. Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws
•    Experience with global drug development and NDA filing is preferred
•    Experience with project management

WORKING CONDITIONS:  
•    PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear.  Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.  

•    WORK ENVIRONMENT:  The noise level in the work environment is usually moderate.  Some travel may be required.  

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law