- Drafts, reviews, negotiates, and manages a variety of standard transactional agreements and amendments, including clinical trial agreements, master services agreements, consulting agreements, statements of work, and non-disclosure agreements, with minimal attorney supervision.
- Provides practical, solution-oriented contracts support to business partners and ensures contracts are delivered according to required timelines.
- Completes quality checks on final agreements regarding language and related data.
- Escalates contracting issues with Legal team members and business partners as required.
- Works with Legal Operations to support 4DMT's contract management system.
- Bachelor's degrees and/or relevant legal education (paralegal certification)
- Minimum 3 years of contracts experience in a law firm or in-house law department at a public biotechnology / pharmaceutical company
- Good understanding of clinical trial contracting
- Excellent communication (verbal and written), listening, and negotiation skills
- Experience with contract management systems (Ironclad a plus)
- Ability to engage critical thinking to provide a solutions-oriented approach to client needs.
- A strong self-starter who is adaptable, flexible, and creative in a rapidly changing environment
- Can manage several complex projects simultaneously while working to meet deadlines, includes planning and prioritizing work without direct supervision
- A history of operating with transparency, professionalism, emotional intelligence, and integrity.
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Contracts Specialist - Emeryville, United States - BioSpace, Inc.
Description
Job DetailsAttention 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
Accordingly, 4DMT seeks a Contracts Specialist to provide transactional support for the late-stage clinical programs. Reporting to the Senior Director, Corporate Counsel, this person will draft and negotiate standard contracts, including CTAs, MSAs, CDAs, SOWs, change orders, consulting agreements, and amendments, and support filings, record keeping, and other contracts administrative work. The ideal candidate will have experience in these areas to work independently and in a fast-paced environment, with specific expertise in the biotechnology/pharmaceutical industry. This position is a hybrid role with corporate headquarters in Emeryville, CA.
Responsibilities
Please note that compensation varies depending on various factors, including experience, location, etc.
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
