Principal Clinical Scientist, Director Clinical Development - Oncology

Title:                                 Senior Scientist, Clinical Development – Oncology
Reports To:                      To Be Determined 
Location:                          Redwood City, California
Classification:                  Exempt 

Overview:

The Principal Clinical Scientist/ Director, Clinical Development – Oncology will provide medical leadership and oversight of the Coherus Oncology clinical trial design programs. Key immediate opportunities include:

Responsibilities:

• Acquires and uses knowledge of clinical trial design to develop specific study concept sheets and protocols.
• Participates in protocol review discussions concerning scientific and procedural aspects of study design.
• Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
• Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
• Addresses questions regarding scientific and related procedural issues from Investigators.
• Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
• Assists in the preparation/review of regulatory documents.
• Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
• May be asked to coordinate teams and provide direction.
• May provide clinical monitoring for one or more clinical studies or components of larger studies.
• Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice.

Qualifications:                      

• Typically requires a PharmD or PhD with 8+ years' relevant scientific and/or drug development experience in clinical research or clinical pharmacology with scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• MS with 10+ years' relevant scientific and/or drug development experience.
• BS or RN with 12+ years' relevant scientific and/or drug development experience.
• Relevant experience in Oncology therapeutic area is preferred.
• Experienced with Microsoft Office and other job-related programs.

Education and Experience Requirements:

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Understands drug development phases and the nature of associated clinical trials across phases.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Strong communication and organizational skills.
• When needed, ability to travel.

The Base Salary Range for this position is $185,000 to $220,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.