Clinical Scientist

Corvus Pharmaceuticals, Inc.; San Francisco (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Corvus Pharmaceuticals, Inc. in the San Francisco Bay Area is seeking an experienced Clinical Development professional to support strategic clinical plans and study protocols. The role involves regulatory writing and close collaboration with senior leadership, data management, and trial teams.

You will prepare Investigator Brochures, DSURs, and other submissions, lead coordinating activities, and help ensure timely, high-quality deliverables in a fast-paced biotech environment.

Qualifications

• Must have biotech experience with oncology, dermatology or autoimmune disease.
• Strong regulatory writing skills and ability to draft clinical documents.
• Excellent teamwork, collaboration and communication.

Responsibilities

• Writes and edits clinical plans, protocols and amendments with senior input.
• Supports Investigator Brochures, DSURs and other regulatory documents.
• Coordinates data review, adverse event review and trial activities with teams.
• May lead small teams and coordinate field site activities.

Skills

Biotech experience

Regulatory writing

Team leadership

Communication

Education

PhD, PharmD, RN, NP or PA

Tools

Microsoft Office

Job description

Department/Group:Clinical Development
Location:South San Francisco, CA
Position Type:Full time

Job Description

Role and Responsibilities

• Provides strategic input and development support for clinical plans and individual study protocols
• Writes or assists in writing of clinical plans and study protocols and protocol amendments in close collaboration with VP, Clinical Development
• Writes or assists in writing Investigator Brochures, DSURs and other regulatory documents
• Assist other team members in Clinical Development in the implementation and conduct of clinical trial which includes but not limited to review of enrollment packets, review of adverse events and all other clinical data generated during conduct of trial
• Assist in Medical Monitor responsibilities
• Work closely with Data Management to ensure that all relevant clinical data is collected in a timely manner and assist with cleaning of data listings
• Participates in the development of clinical operating guides and maintains secure study files
• Reviews results of these evaluations with appropriate management prior to implementation
• May require travel to field sites and scientific meetings
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
• Determines methods and procedures on new assignments
• May coordinate activities of other personnel (team lead)

Qualifications and Education Requirements

PhD, PharmD, RN, Nurse Practitioner or Physician Assistant required

5+ years of biotech experience (oncology, dermatology or autoimmune disease)

Preferred Skills

• Excellent teamwork and collaboration skills
• Proficient with Microsoft Office.
• Able to build effective working relationships throughout the organization internally and externally to achieve goals.
• Flexibility and willingness to solve problems that fall outside of immediate area of expertise
• Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
• Work independently in an interdisciplinary, fast-paced, often changing environment.
• Committed to the values of integrity, accountability, transparency, and drive.