At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.
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.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
• 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
Reporting to the Chief Medical Officer, the Contract (6-12 months) Sr. Manager of Safety/Pharmacovigilance Operations is responsible for providing oversight and day to day management of all activities pertaining to product safety and pharmacovigilance operations in clinical development, The Contract Sr. Manager of Safety/Pharmacovigilance Operations ensures that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for 4DMT products.
- In collaboration with the CMO, support the safety governance oversight for all company products.
- Collect, synthesize and deploy relevant drug safety information on all programs within 4DMT models.
- Organize and lead ongoing safety data review and signal detection, management of serious adverse event reporting, aggregate safety reporting, management of risk-benefit profiles, risk management and mitigation plans for all clinical stage programs
- Directly oversees the PV vendors/service providers to ensure that they fulfill their accountabilities and responsibilities, which includes ensuring high quality and on time case processing and aggregate reporting, as well as ensuring appropriate documentation and governance frameworks are in place
- Act as a sponsor Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide input on case processing activities for 4DMT products
- Ensures that adverse events from spontaneous cases, solicited cases from studies and programs involving 4DMT products be collected, reported, and handled in accordance with global/local regulatory requirements and company policies
- Collaborate with appropriate clinical operations, clinical development, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including authoring as appropriate and review of documents such as DSUR, IB, clinical study protocols, informed consent forms, DSMB charters/meeting materials, development plans, Safety Management Plans (SMPs) and INDs/CTAs
- Support SAE Reconciliation activities for all 4DMT ongoing studies
- Provide safety operations expertise to other 4DMT therapeutic functions
- Represent PV function in audits with health authorities and development partners
- In collaboration with QA, overseeing and support implementation of safety related CAPAs, as necessary
- Support development of training modules and provide training in Pharmacovigilance across the Company
- Other duties as assigned
- Experience in ophthalmology/gene therapy a plus
- RN or other clinical equivalent degree required with strong relevant work experience
- 6+ years' experience in a Pharmacovigilance Operations role within the Pharmaceutical / Biotechnology industry
- Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations Previous experience managing PV vendors required
- Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
- Ability to work collaboratively with the internal partners and ability to build relationships with clinical sites and outside vendors
- The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills are required
- Attention to details, able to proactively identify issues and propose solutions
- Excellent written and verbal communication skills
Physical Requirements of the Role:
- Sitting for prolonged periods of time working on a computer
Base compensation range:
Please note, the base compensation range and actual compensation offered to the final candidate is dependent on variety of 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