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Senior Manager, Legal Operations (Hybrid)

4D Molecular Therapeutics
Posted Jan 25
Full Time
Emeryville, California

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. 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

4DMT is seeking an experienced legal operations manager to manage the implementation of new legal technology and help revamp their legal processes and procedures to optimize efficiency, consistency, and collaboration across the department. Ideal candidates will be well-versed in Contracts Lifecycle Management (CLM) and records/document management platforms and will have experience developing a strategic plan for and leading the implementation of a CLM and other legal platforms for an established legal department.

The Senior Manager, Legal Operations supports the effective and efficient functioning of the Legal team by managing legal operations and by identifying and implementing opportunities to optimize the operational and organizational aspects of running an excellent in-house legal department at a pre-commercial biopharmaceutical company. The Senior Manager will also participate in records management, risk management, SOX compliance, and other cross-functional projects, as needs arise. The Senior Manager must be able to adapt to changing priorities and business needs and must be proactive in identifying areas of improvement and taking action to address them.

This is an exciting opportunity to work with other members of a growing legal team and across the organization and gain exposure to a wide variety of business and legal issues at a clinical stage public biotech company.

The ideal candidate must be an experienced legal operations manager, paralegal, or contracts manager, with a strong background in the life sciences industry and excellent business judgment and interpersonal skills.

In this role, the Senior Manager, Legal Operations will report directly to the Director, Corporate Counsel, based out of our Emeryville, CA office.

RESPONSIBILITIES:

  • Serve as platform to drive operational efficiency.
  • Develop and implement systems, technology, policies, and procedures in coordination with legal personnel and other departments to improve departmental workflow and consistency.
  • Develop and track metrics as a means of measuring and communicating Legal Department value, achievement of departmental goals, and progress.
  • Provide ongoing training and support on processes and technologies for all Legal Department resources.
  • Drive and collaborate cross-functionally on records management and risk management projects.
  • Support contracts managers and counsel in the review, drafting, and execution of commercial agreements and advise on the development of templates, playbooks, and approved language of commercial agreements.
  • Review/negotiate NDAs/CDAs, consulting agreements, and vendor agreements.
  • Interface with internal stakeholders and external parties to set expectations and gather information necessary for contract review, drafting, and negotiation.

QUALIFICATIONS:

  • 8+ years of experience as a contracts manager, contracts specialist, or commercial counsel with experience overseeing legal operations.
  • Must have experience implementing a CLM. Experience with Ironclad and/or Coupa is a plus.
  • Experience using and managing other technology utilized by in-house legal departments, including legal document management systems, DocuSign, and MS SharePoint.
  • Experience in the life sciences industry strongly preferred.
  • Excellent oral and written communication skills. Strong leadership, managerial and interpersonal skills.
  • Strong self-starter, detail oriented and organized, who can manage multiple projects and meet deadlines.
  • Ability to make decisions and work independently, while also collaborating with key stakeholders and Legal Department team members.

Education:

  • BA/BSc from four year college.
  • Major in a biological field related to the biopharma industry a plus.
  • Paralegal certification a plus.

Base salary compensation range: Bay Area base annual salary compensation range is $143,000/yr - $176,000/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

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