Clinical Science Specialist

Location
South San Francisco, California
Posted
Jun 11, 2018
Required Education
Other
Position Type
Full time

About Principia:

Principia Biopharma is a clinical stage biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and inflammation. As such, we are comprised of a team of exceptionally talented scientists and business leaders. We are seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. Principia’s novel approach to drug development combines the dosing convenience of a small molecule drug with characteristics of an antibody. Our drugs are designed to be effective, potent, selective, durable and safer than traditional small molecule drugs. 

Principia Biopharma seeks candidates who are highly self-motivated and can work in a collaborative fashion with other interdisciplinary team members in a fast-paced company that seeks to transform the treatment of autoimmune diseases using oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitors.

Key Interactions:
Reports to the CMO

  • Works with the CMO to deliver high priority clinical projects and ensure smooth running of clinical teams
  • May lead safety and other clinical data assessments
  • Collaborates with the SVP, Development Operations in the ongoing review of clinical data, including medical review of patient profiles for ongoing safety and efficacy assessment, query generation and review of serious adverse events

Essential Duties:

  • Responsible for the implementation of clinical trial programs for assigned projects – may serve as medical monitor on some trials.
  • Assists with design, development and writing of clinical protocols and other clinical trial documents
  • Interacts with academic thought leaders to optimize clinical trial strategies and synthesizes the input into sound clinical trial designs
  • Develops scientific training materials and presentations for internal and external training to support clinical operations and development activities
  • Writes clinical science sections of Regulatory meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
  • Reviews and interprets the clinical safety and efficacy data for clinical accuracy and obtained from the clinical trials, generates data queries working with the clinical operations team to manage and address
  • Participates in the periodic review of safety information
  • Conducts a review of published literature or of clinical and preclinical reports in the field to provide the context for clinical development programs
  • Other projects as assigned by the CMO

Qualifications/ Requirements:

Education and/or experience:

  • Medical science degree ± advanced training/degree
  • 5+ years of relevant experience in Pharmaceutical/Biotech or equivalent academic experience
  • Proven experience in data analysis, scientific writing/presention of results in internal and external meetings, regulatory documents
  • Small molecule experience with good understanding of clinical pharmacology a plus

Special skills/knowledge:

  • Knowledge of Good Clinical Practices and pertinent adverse event reporting regulations
  • Excellent organizational and computer skills are essential
  • Results and goal oriented
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
  • Thrives in a team
  • Excellent interpersonal skills to be able to build strong internal and external relationships
  • Excellent written and verbal communication skills as well as the ability to present information to a wide range of groups/entities
  • Excellent attention to detail
  • Ability to work with minimal supervision