Associate Director, Clinical Science

Location
San Francisco, CA, United States
Posted
Nov 02, 2020
Ref
863
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
ASSOCIATE DIRECTOR, CLINICAL SCIENCE

Position Summary:

The Clinical Scientist (CS) will support development and execution of medical and clinical strategy for one or more clinical teams and will provide clinical scientist input into the conduct and interpretation of clinical trials. The CS will support and represent as needed the clinical development function to provide key strategic input and data at the SCD Clinical Science Team (CST) team and other related working groups.

Essential Duties and Responsibilities:
  • Provide relevant CS expertise to internal teams, including clinical operations, medical writing, data management, and pharmacovigilance to ensure quality processes and deliverables
  • Contribute to development and execution of medical & clinical strategy for assigned product(s)
  • Represent Clinical Development functional group on a study execution team(s) (SET)
  • Support Clinical Trial Lead/Medical Director to provide scientific leadership in execution of clinical trials
  • Contribute to development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy
  • Fulfil key roles in data cleaning, CRF design, preparation of data extracts for clinical documents, IB updates
  • Play a leading role on RA filings and submissions by composing and reviewing documents with review of current literature and providing key GBT study related scientific evidence, data, and interpretation
  • Act on behalf of Clinical Trial Lead and/or Medical Monitor leading the interpretation of trial data and development and review of clinical study documents, reports, etc. as needed
  • Support Clinical Trail Lead/Medical Director to provide scientific leadership in execution of clinical trials
  • The position will report to the
  • Senior or Executive Director in Clinical Science
  • Participate/contribute in cross-functional team meetings
  • Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution
  • Prepare clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses
  • Provide CS input into regulatory questions
  • Remain up-to-date on current literature, scientific progress, and drug development activities in SCD and related areas
  • Run ad hoc searches of medical literature and provide summaries as needed
  • Prepare targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
  • Serve as a resource to address medical questions or clarify issues arising during conduct of the study
  • Provide support or act as company representative interacting with external scientific leaders, investigation sites and/or Regulatory authorities as needed
  • Assist Business Development with assessments and intelligence on potential new products and assist with due diligence activities as required
  • Assist with ongoing monitoring of safety data and regular medical review of clinical trial data as needed

Qualifications:
  • Masters, PharmD (preferred), MD (preferred), or PhD (preferred) degree is required. Scientific/healthcare field preferred but not required
  • Significant experience (3-5 years) of clinical research and organizational management within the pharmaceutical industry
  • Demonstrated ability to collaborate in a matrix environment
  • Significant successful interactions with key opinion leaders and investigators
  • An excellent scientific track record demonstrated by publication record in refereed journals
  • Proven ability to effectively work in a cross-functional/matrix environment and successfully leverage internal and external partnerships
  • Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
  • Strategic agility; in-depth knowledge and broad experience in the pharmaceutical or biotech industry and able to bring this to bear in accomplishing strategic goals and objectives
  • Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions
  • Strong interpersonal, influencing, presentation, and written and verbal communications skills; able to effectively address all levels within an organization
  • Requires ability to resolve interpersonal issues and motivate individuals and teams towards achieving results. Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts. Requires high degree of problem-solving ability; understanding of objectives and processes across multiple organizational functions.
  • Willingness and ability to travel up to 20%
  • Availability to participate in early or late meetings/teleconferences

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.