Clinical Scientist

Location
San Francisco, CA, United States
Posted
Nov 17, 2020
Ref
5197-515-R
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Clinical Scientist to join their Clinical Development team.

The Clinical Scientist supports the assigned clinical study team(s) on one or more clinical studies with various deliverables necessary for effective and efficient clinical development plan execution for the assigned molecule(s)/indication(s). This is junior level position in this job family, and the Clinical Scientist has primary responsibilities for supporting the Clinical Development Lead on study teams, with limited guidance. The Clinical Scientist interacts with other cross functional team members to ensure effective representation of the needs of each function within the study protocol and related study plans and may also have external interactions with vendors, investigators, key opinion leaders (KOLs), and cooperative groups supporting the clinical development plan. Success in this role requires basic understanding of clinical study execution, technical proficiency, scientific creativity, independent thought, effective communication and collaboration skills, and the ability to exercise good judgment within defined procedures and practices to determine appropriate action. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
  • Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought. Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Support Clinical Development Lead of one or more clinical studies in the development of scientific and medical strategy and content for study protocols
  • Participate in writing clinical study protocols and protocol amendments
  • Review template informed consent form templates to ensure alignment with protocol and Investigator Brochure(s)
  • Participate in cross-functional study team for one or more assigned studies and collaborate with internal and external stakeholders to facilitate understanding and achievement of scientific/medical objectives
  • Actively participate in development and review of study charters, manuals, work instructions, case report form specifications, statement of work specifications, etc. to ensure accuracy and alignment with the protocol
  • Manage and track ongoing study data and participate in regular in-depth data reviews (data cleaning); prepare and may present summaries for internal or external study updates; identify potential issues and present proposals to improve quality, accuracy, efficiency, etc. of study conduct and data collection; present proposals for updated or new research, etc.
  • Advise in cross-functional development of strategies for clinical data collection and monitoring and signal detection
  • Participate in the planning and execution of investigator meetings, study initiation visits, and study-related committee meetings (e.g., steering committee and independent data monitoring committee)
  • Develop study training materials and deliver training to internal and external colleagues and site study teams (e.g., clinical research administrator training, pre-study and site initiation visits, investigator meetings)
  • Draft and manage responses to site queries regarding protocol or related data clarifications
  • Support in drafting responses for health authority or ethics committee questions and requests for information
  • Contribute to the writing and review of data presentations and publications (abstracts, posters, slide presentations, other communications) and may help to coordinate reviews and adjudication with internal and external stakeholders
  • Participate in writing and review of clinical study report and preparation for potential NDA/BLA filings
  • Participate in cross-functional working groups to provide clinical perspectives in the development of program- or company-wide processes
  • Stay abreast of current literature, attend scientific and clinical research conferences, and establish relationships with therapeutic area experts to maintain scientific and clinical knowledge in the assigned disease and therapeutic area(s) and to inform program clinical research objectives
  • May act as a standing or ad hoc member of sub-teams or working groups
  • Consistently comply with all governing laws, regulations, standard operating procedures (SOPs) and other relevant guidelines
  • Other duties as assigned
PhD required; equivalent experience or other advanced degree (MD, PharmD, MSN, MPH, etc.) may be accepted. Life sciences degree is preferred. Exceptional candidates without advanced degree with demonstrated capabilities and/or significant experience may also be considered. Minimum 2 years of experience in clinical science (or equivalent role) and 2 years of industry experience preferred. Solid beginning experience in clinical trial design and conduct, including knowledge of GCP and ICH guidelines, good understanding of the multidisciplinary functions within drug development, and experience working collaboratively and effectively in cross-functional clinical study teams. Experience writing, editing and reviewing protocols, informed consent templates, study manuals, vendor charters, conference presentations, journal publications. Experience interacting with investigators, coordinators, and other site staff to share knowledge and feedback related to study protocol development and execution. Relevant therapeutic area experience preferred. Demonstrated abilities in critical thinking and research methods; strong independent research and problem-solving skills. Strong organization and time management skills. Strong verbal and written communication skills; experience in delivering written reports and oral presentations within industry setting preferred. Demonstrated abilities to work effectively in a cross-functional team, to influence others, and to effectively manage conflict. Demonstrated exercise of good judgment, effective use of resources, and understanding of when to seek advice or escalate decisions. Ability to be detail-oriented and provide close reviews of extensive documentation to ensure accuracy, completeness, and consistency of study- and program-supporting materials. Effective interpersonal skills amenable to collaboration and building and maintaining relationships internally and externally within relevant fields. Proficient computer skills in Microsoft Office Suite (Word, PowerPoint and Excel) required. Ability to travel (

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.