Sr. Clinical Scientist

Location
San Francisco, CA, United States
Posted
Nov 12, 2020
Ref
5181-515-R
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Sr. Scientist, Clinical Research to join their Clinical Development Team.

The Sr. Scientist, Clinical Research is responsible for various deliverables necessary for effective and efficient clinical development plan execution for the assigned molecule(s)/indication(s). This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought. Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Design and writing of clinical study protocols and protocol amendments
  • Participate in cross-functional development of clinical data collection and monitoring and signal detection strategies and active participation in ongoing study data review
  • Participate in the planning and execution of investigator meetings, study initiation visits, and steering committee and independent data monitoring committee meetings
  • Review of template informed consent forms to ensure alignment with protocol and Investigator Brochure(s)
  • Review of study charters, manuals, work instructions, case report form specifications, statement of work specifications, etc. to ensure accuracy and alignment with the protocol
  • Develop study training materials and deliver training to internal and external colleagues and site study teams
  • Draft responses for health authority or ethics committee questions and requests for information
  • Draft and manage responses to site queries regarding protocol or related data clarifications
  • Participate in cross-functional working groups to provide clinical perspectives in the development of program- or company-wide processes
  • Contribute to and review the writing of Investigator Brochures, data presentations, and publications
  • Participate in clinical study report development and preparation for potential NDA/BLA filings
  • Literature research and presentation to analyze therapeutic landscape development and inform program clinical research objectives
  • Other duties as assigned
A PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 5 years work experience in a research and/or development environment is required of which a minimum 3 years of experience in clinical development or clinical trial conduct, preferably with 2 years of industry experience. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or equivalent experience may also be considered. Well-rounded experience in clinical trial design and conduct, including knowledge of GCP and ICH guidelines, good understanding of different functional roles within drug development, and experience working collaboratively and effectively in cross-functional clinical study teams. Confident communication and presentation skills. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Must possess good oral and written communication skills. Ability to present technical information to both technical and non-technical audiences is required.
  • Strong independent research and problem-solving skills
  • Proactive and effective conflict resolution skills
  • Experience writing, editing and reviewing protocols, investigator brochures, informed consent templates, study manuals, vendor charters, conference presentations, journal publications
  • Experience interacting with key opinion leaders, investigators, coordinators, and other site staff to share knowledge and feedback related to study protocol development and execution
  • Proficient computer skills and experience with standard software (e.g., Word, Excel, OneNote, Outlook, PowerPoint, Smartsheet, SharePoint)
  • Relevant therapeutic area experience preferred
  • Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment.
  • Must be able to demonstrate sound judgment.
  • Strong organizational skills are required.
  • Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired.
  • Previous management skills are a plus.
  • Must be willing to work as part of a team.
  • Must be able to demonstrate good interpersonal skills.


We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.