Associate Director, IT Compliance

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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 Associate Director, IT Compliance will report director to the Sr. VP, IT & Facilities. This role is directly responsible for developing, implementing & maintaining 4DMT's IT compliance program meeting all applicable regulatory requirements including GxP (Part 11), SOX (Sarbanes Oxley Act) & privacy laws (GDPR, CCPA).

RESPONSIBILITIES:

Ensures 4DMT IT operates in compliance to GxP, SOX & Privacy regulations & ensures compliance objectives are demonstrably met with auditable evidence on an ongoing basis.

Builds effective partnerships with business process owners, IT system owners, system administrators, Quality staff, internal/external auditors, inspectors & other cross-functional stakeholders to develop, implement & maintain the IT compliance program.

Develops, manages & maintains compliance strategy, governance, policies, processes, controls, improvements, risk assessments, compliance checks & team domain knowledge to ensure the following key activities are effectively & efficiently executed for 4DMT IT systems:

System Validation, Periodic Review

IT Change Management & SDLC

Data Integrity, Service Continuity & Data Protection/Backup

System Access & Inventory Management

IT Incident, Non-Conformance, CAPA Management

IT Document Control, Training & Curriculum Management

SOX Risks & Controls Design, Operational Effectiveness & Testing

IT Supplier Assessment & Service Organization Control (SOC1) Reviews

Auditor/Inspector Relations & Inspection Management

Manages IT compliance-related staff, service providers, budgets, audits, inspections & projects.

Conducts risk assessments of key systems, accounts, & other in scope areas & activities.

Acts as the primary IT contact for all related compliance audits or inspections, including those related to SOX, GxP & Privacy.

Provides expert consulting across 4DMT stakeholders of the IT regulatory landscape & upcoming changes, of compliance requirements & best practices & of continuous improvement.

Develops, socializes & reinforces responsibility matrices to ensure compliance responsibilities are clearly understood throughout 4DMT.

QUALIFICATIONS:

Education:

Bachelor's Degree in a Life Science or Computer Science.

Certifications related to GxP, SOX & Privacy regulations, IT operations & project management strongly preferred.

Experience:

8+ years directly managing or auditing IT operational process

3+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5

3+ years of experience in a senior IT leadership position w/demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry.

Recent roles & achievements that demonstrate clear expertise delivering & maintaining compliant Accounting, QA/QC, Manufacturing, Clinical, Quality, Facilities & IT applications, segregations of duty, interfaces & processes.

Direct involvement as IT lead for at least one FDA inspection & for multiple annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties & SSAE-18 SOC Report reviews

Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead.

Demonstrated understanding of project management methodology, & experience adopting industry best practices. PMP, ITIL, or other formal certification is desired.

Skills:

Strong knowledge of IT implications of cGMP, GCP & ICH guidelines, Part 11/Annex 11 for US, Canada & EU markets; SOX; & privacy regulations

Solid GAMP5-based SDLC/validation skills

Strong skills designing & auditing compliant IT operational processes including SDLC, Change, Access, Inventory, Data Protection/Backup, Service Continuity Management.

Strong skills utilizing & administering GRC, QMS & LMS tools required.

Skills with Veeva eTMF, ELN/LIMS, NetSuite, Coupa, ADP & SharePoint a plus.

Collaborative Communication Skills:

Ability to work with a diverse group of personalities & individuals

Excellent document authoring, review & writing skills

Strong verbal communication skills

Ability to work independently, multitask, strong attention to detail & accuracy

Proven ability to set schedules & meet deadlines

Base salary compensation range:

Bay Area Range: $171,000/yr - $225,000/yr

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

Permanent