Director, Pharmacovigilance

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY: 

The Director of Pharmacovigilance is responsible for implementing and coordinating pharmacovigilance activities for 4DMT products.  This position will be a knowledge leader for 4DMT products and actively participate in safety related aspects of the product life cycle from development to post-marketing to ensure rigorous analysis, critical decision making, and communication of safety information to internal 4DMT groups and regulatory authorities.  It is expected that this person will develop a proactive, forward-looking program of communicating safety information and directions for safety product use to stakeholders both internal and external.  Knowledge of safety operations and systems is important to this position.

The person will be a key interface and participant with internal 4DMT groups such as Clinical Science, Clinical Operations, Regulatory, and Compliance/Quality. Documentation of the origin, ongoing history, and closure of safety issues will be critical.

The person will ensure corporate compliance with domestic and international adverse event and safety issue reporting requirements, interpreting the medical significance of incoming safety information, and performing regular risk management assessments of assigned products. 

RESPONSIBILITIES:  

Provides regional support for activities associated with safety compliance, operations, and medical review as needed. 

QUALIFICATIONS: 

Compensation Range: $210,000/year - $270,000/year

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

  4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities