Director, Pharmacovigilance

1 month ago

Emeryville, United States 4D Molecular Therapeutics Full time

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers 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.  

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.

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:  

Act as safety leader with responsibility for signal detection and assessment activities for 4DMT products. Such activities may include preparation of signal assessment and validation documents such as signal summary reports; tracking and using safety database tools for aggregating safety data; leading cross functional teams to assess safety signals; creation of action plans to mitigate/manage product risks; responding to safety associated Health Authority requests; development and maintenance of product Risk Management Plans (RMP); monitor the safety profile of delegated products and recommend appropriate action including labeling amendments and risk management programs when warranted assess product specific adverse event information to determine required action based on internal policies; and providing medical assessment as relevant. Participation in maintaining and upgrading pharmacovigilance processes. These may include MedDRA maintenance, PV systems policies, and implementation of new regional and cross-regional PV regulations.  Ensures corporate compliance with domestic and international adverse event and safety issue reporting requirements for delegated products. Prepares safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, annual safety reports, Investigator Brochures, Development Safety Update Reports (DSUR), and Annual safety update reports (ASUR), and other aggregate reports). Reviews ICFs, clinical study non-serious adverse event line listings and other study related documents containing safety information. May assist with approving, reviewing, and contributing to publications (abstracts, posters, papers) for scientific meetings/journals. Assists with contributing to safety components of strategic documents and to development of Target Product Profile (TPP). Act as the safety liaison/resource on study project teams for safety related issues relating to clinical development. Supervise PV activities and personnel related to licensing partners and CROs. Provides support as required for licensing activities, regulatory authority inspections audits and for project product recall activities. Collaborates with other departments (e.g., training) to provide expertise and guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics. Interacts with service providers as required to address safety queries, share best practices, and discuss new safety regulations.

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

QUALIFICATIONS: 

MD, PharmD., RN, BSN, Nurse Practitioner, Pharmacist or related degree with at least 5+ years pharmaceutical industry, pharmaceutical industry safety surveillance, or applicable clinical/medical experience required. Demonstrated knowledge of domestic and international ADE reporting regulations per guidelines and follow timelines as necessary for regulatory reporting purposes. Demonstrated knowledge and proficiency with drug safety databases (i.e. ARISg or ARGUS) Proficiency with standard office skills and standard desktop computing programs Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a team environment, cross functionally, and work with multiregional organizations. Highly organized and demonstrates understanding of workflow prioritization. Ability to multitask and triage as needed with the ability to work independently, under pressure, demonstrating initiative and flexibility. Excellent understanding of clinical trial methodology, GCP and medical terminology Attention to detail and quality focused with strong technical and problem-solving skills Strong organizational and project management skills Strong communication skills and the ability to operate effectively in an international environment Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety database applications.

 

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

  • Director, Pharmacovigilance

    1 month ago

    Emeryville, California, United States 4D Molecular Therapeutics Full time

    Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...

  • Director, Safety Operations Lead

    5 days ago

    Emeryville, California, United States BeiGene Full time

    About the RoleWe are seeking a highly skilled and experienced Director, Safety Scientist to join our team at BeiGene. As a key member of our Safety Science group, you will play a critical role in supporting assigned compounds and leading the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries,...

  • Medical Director, Hematology

    2 weeks ago

    Emeryville, United States BeiGene Full time

    The **Medical Director, Hematology** will support BeiGene Clinical and Medical assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. As a leader in the organization, the incumbent will be accountable to...

  • Director of Medical Writing and Content Strategy

    2 hours ago

    Emeryville, California, United States Kyverna Therapeutics, Inc. Full time

    About the RoleKyverna Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative cell therapies for autoimmune diseases. We are seeking a highly skilled and experienced Director of Medical Writing and Content Strategy to join our team.Key ResponsibilitiesLeadership and Strategy:Lead and manage a team of medical writers,...