Senior Director, Clinical Science

Employer
Retrophin
Location
San Diego, California
Posted
Oct 24, 2020
Ref
R-100074
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Department:
106700 Clinical Dev - Renal

Location:
San Diego
Position Summary:

The Senior Director, Clinical Science is an integral member of the Clinical Development Team, who will help to develop innovative solutions for the clinical development of Retrophin's early and late stage assets. Working in close collaboration with the project teams, the incumbent will provide scientific guidance and support in all aspects of the clinical program such as study design, development, execution, data readout, and summary. This position will also be a resource to teams for guidance of all matters related to analysis and communication of clinical data.

Essential Functions:
  • Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management.
  • Supports all operational aspects of clinical trial activities (Phase I through IV) and clinical program activities.
  • Partners with Clinical Operations in identifying potential investigators and sites for clinical trials and contributes to the selection of external vendors by reviewing scope of work, budget and timelines.
  • Responsible for the development of clinical trial protocols based on the study design and related documents and support development of study tools including guidelines and training materials for study sites and investigators.
  • Communicates with CROs as well as clinical and analytical laboratories.
  • Supports and coordinates Investigator initiated studies (IIRS).
  • Responsible for reviewing various proposals from investigators.
  • Supports clinical outsourcing specifications and day to day operational activities with Contract Research Organization(s) (CROs) and other 3rd parties.
  • Contributes to the ongoing scientific review of the clinical trial data during the trial.
  • Supports trial data analysis and reporting (e.g., SAEs).
  • Partners with Study Medical Monitors, creates required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND.
  • Works closely with Clinical Operations to execute the clinical trial with high quality and according to timelines.
  • Performs ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretation.
  • Provides scientific expertise to Clinical Operations by responding to questions or clarifying issues arising during study conduct.
  • Provides internal safety monitoring for clinical trials in collaboration with the Study Medical Monitors.
  • Provides medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plans.
  • Develops and maintains relationships with clinical trial investigators and therapeutic area key opinion leaders (KOL).
  • Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
  • Collaborates with a variety of internal and external partners and stakeholders, including clinical investigators, clinicians and KOLs, as well as multidisciplinary internal groups, including other groups, research, business development and commercial operations.
  • Contributes to the development of plan for assigned molecules, indications and other programs.
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work to maintain a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease areas.


Qualifications:
  • Master's degree, Pharm D, PhD, or MD in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
  • 8+ years of experience needed in Biotech or Pharmaceutical industry in clinical development with previous experience as a clinical scientist, including: data review, safety monitoring, protocol development, supporting data analyses, interpretation and publications, experience working on cross functional clinical trial teams and liaising with study investigators. 3-5 years of progressive leadership roles.
  • Prior experience with relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR, is a plus.
  • Experience in translational medicine/early phase clinical trials is a plus.
  • Demonstrated ability to review, interpret and present complex scientific data.
  • Excellent problem-solving skills, a strong sense of urgency and keen attention to detail.
  • Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures.
  • Ability to work independently while also having excellent collaboration skills.
  • Strong interpersonal and organizational skills, and excellent verbal and written communication skills are required.
  • Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
  • Ability to travel up to 20% domestic and internationally.


Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer