Director of Pharmacovilgilance

180 - Clinical · Berkeley, California
Department 180 - Clinical
Employment Type Full-Time
Minimum Experience Experienced

Caribou Biosciences, Inc. is a leading clinical-stage CRISPR genome engineering biotechnology company located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of genome-edited cell therapies for various oncology indications. The eight-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position. At Caribou, every employee is valued for their unique perspective, background, and diversity. Every person on the Caribou team contributes to problem solving and innovation. The Company’s vision is to advance agile genome editing innovations for the benefit of our communities.

 

The Company is seeking an experienced physician to establish, direct, and manage the pharmacovigilance and clinical risk management for clinical trials. The role is a key part of Caribou’s clinical development function and the successful candidate will play a leadership role in medical assessment and communication of clinical trial safety management and results. 

 

Duties and responsibilities:

  • Assess and oversee the medical evaluation of patient safety in clinical trials
  • Perform medical case review of individual safety reports and patient narratives including review of source documents as appropriate
  • Review safety coding of data
  • Perform aggregate safety data reviews, signal detection, and trends analysis from clinical trials; interpret safety findings from clinical trial data
  • Review seriousness, expectedness, and causality of adverse event reporting
  • Prepare and write medical assessments and analysis of clinical events
  • Oversee vendor safety activities and execution, including data collection process
  • Monitor safety adherence to protocols and clinical trial execution
  • Prepare relevant safety sections of investigator brochures, study protocols, publications, and regulatory filings including briefing documents, reports, and regulatory submissions
  • Develop and carry out risk minimization action plans
  • Monitor safety adherence to protocols and clinical trial execution; ensure safety audit preparedness
  • Prepare SOPs and safety project procedures as needed
  • Review all data from clinical trials
  • Review and assist in writing abstracts, publications, and relevant medical documents for scientific use as needed
  • Provide medical and safety support to clinical development activities, including clinical protocol development and safety database development
  • Develop and deliver medical and safety training content
  • Keep up to date with relevant regulations, legislation, and literature of pharmacovigilance and pharmacoepidemiology
  • Travel up to 25% of the time

 

Candidate must have the following qualifications:

  • MD degree and direct clinical practice experience
  • Board certified or eligible physician  
  • Minimum of 7 years of experience in pharmacovigilance planning and implementation in pharma or biotech
  • Demonstrated experience developing safety and risk management plans, overseeing the quality of safety database development and maintenance, meeting regulatory agency requirements for safety compliance, and understanding of industry principles of pharmacovigilance
  • Excellent verbal and written communication skills
  • Attention to detail and good computer skills
  • Proven ability to work independently, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environment
  • Strong organizational and time management skills
  • Capable of managing multiple diverse projects simultaneously 
  • Flexible to support medical initiatives outside pharmacovigilance as needed

 

Additional positives:

  • Experience working in a small biotech organization
  • Working knowledge of epidemiology and biostatistics
  • Authorship in research publications, presentations of research

 

Caribou Biosciences, Inc. is a dynamic start-up biotechnology company, and the successful candidate should have a passion for science and a desire to work in a collaborative environment. Caribou promotes a culture in which employees are respected and valued for hard work, innovation, personal initiative, and teamwork.

 

Caribou offers a comprehensive compensation package, as well as generous paid time off in addition to Company-observed holidays. The Company provides medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions.

 

For more information, please visit www.cariboubio.com. Caribou is on Twitter. Follow the Company @CaribouBio.

 

Caribou is an equal opportunity employer and does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

 

Direct applicants only. No agencies please.

 

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  • Location
    Berkeley, California
  • Department
    180 - Clinical
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced