Description
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
GENERAL SUMMARY
4DMT is seeking an experienced transactional attorney with a broad range of in-house experience to support and counsel its internal stakeholders ranging from pre-clinical through commercial readiness. The role will serve as a key advisor to Clinical Science, Clinical Operations, CMC & Technical Operations, Supply Chain, Medical Affairs and other departments as needed, counseling on transactional matters, risk allocation, and compliance considerations that arise throughout the drug development and manufacturing lifecycle.
The role will have an emphasis on drafting, negotiating, and managing contracts with industry partners, clinical trial sites, CROs, company vendors, HCPs and other entities and is expected to serve as a highly collaborative, attentive, and trusted advisor for its internal stakeholders. Substantive experience drafting and negotiating agreements required for clinical trial execution and clinical product manufacturing is essential. In-depth knowledge of the drug development and clinical trial processes, regulatory and compliance requirements, strategic partnerships, and intellectual property is strongly preferred.
In this role, the Director, Corporate Counsel will report directly to the Executive Director, Corporate Counsel.
MAJOR DUTIES & RESPONSIBILITIES:
- Lead the drafting, review, negotiation, and execution of a broad spectrum of agreements including, without limitation, clinical trial agreements, clinical site and investigator agreements, CRO and other vendor services agreements, master services agreements, work orders, change orders, CDMO development agreements, supply agreements, manufacturing services agreements, quality agreements, material transfer agreements, and technology transfer arrangements.
- Review and advise on clinical trial related documents, such as informed consent forms, letters of authorization, and letters of indemnification, and provide other strategic and legal counsel to clinical trial teams.
- Advise stakeholders on contractual risk allocation, indemnification, limitations of liability, ownership of intellectual property, data rights, confidentiality, and regulatory compliance, providing practical, risk-based legal counsel to support the timely progression of clinical programs and business initiatives.
- Review, approve, and advise on external facing materials & outreach initiatives, providing counsel on potential legal issues and appropriate risk mitigation strategies related thereto.
- Assist with development of Legal Department policies, procedures, templates, and playbooks relating to Legal Department activities.
- Participate in and support continuous improvement of the contracts lifecycle management system.
- Manage the use of outside counsel taking into account cost, speed of review, and technical expertise.
- Other duties as assigned.
QUALIFICATIONS:
Education:
- JD degree or equivalent from an accredited law school required.
- BSc in molecular biology, genetics, biochemistry, or other biological field related to the biopharma industry is beneficial but not required.
- Admission to, and in good standing with, at least one U.S. state bar (CA preferred but not required).
Experience:
- 8+ years practice as an attorney
- 5+ years of in-house experience in the life sciences industry
- In-house experience at a publicly traded biotechnology, pharmaceutical, or biopharmaceutical company strongly preferred.
- Large law firm experience supporting life sciences companies strongly preferred.
- Experience in counseling life sciences clinical and manufacturing teams with respect to day-to-day transactions and risk mitigation strategies.
- Proven experience reviewing and negotiating a wide-range of contracts described herein under tight timelines and with autonomous decision making.
- Proficient knowledge of current laws, regulations and industry standards, such as FDA regulations, ICH Guidelines, GxPs, FDCA, FCPA, FCA, AKS, HIPAA, and data privacy laws.
- Prior experience supporting global clinical trials, including registrational trials, intellectual property and technology related transactions is beneficial to the role.
- Experience handling commercial contract disputes and dispute resolution.
- Excellent analytical skills; creative, pragmatic problem-solving abilities in a transactional context; and efficient, precise drafting of customized agreements.
- Experience working with Finance teams and auditors, managing contracts processes and policies, and using contracts lifecycle management tools.
Other Qualifications/Skills:
- Service-oriented focus with ability to work as part of cross-functional teams and drive results.
- Highest integrity, excellent judgment, and the ability to proactively recognize and effectively communicate legal issues to the Executive Director, Corporate Counsel and other members of company management.
- Innate leadership qualities to identify gaps and a step-up mentality to drive solutions.
- Ability to manage a full docket of responsibilities in a dynamic, fast-paced environment with aggressive timelines.
Travel: 5%
Physical Requirements and Working Conditions:
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $242,000 - 282,000
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.
Similar jobs
Est. 187,500 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 390,000 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 160,000 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 337,500 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 165,000 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 374,000 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 207,000 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 175,000 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 135,500 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 262,500 USD
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disea…
Est. 207,000 USD
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clini…
Est. 209,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 290,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations b…
Est. 210,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 263,000 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 215,000 USD
At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated. As an Adapter, you’ll have the opportunity t…
Est. 212,500 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 120,000 USD
At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support serv…
Est. 212,500 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 273,224 USD
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments…
Est. 80,000 USD
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments…
Est. 177,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 120,000 USD
Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the r…
Est. 120,000 USD
Science 37’s mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the r…
Est. 142,500 USD
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology,…
Est. 177,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 172,500 USD
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments…
Est. 244,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 270,000 USD
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop diffe…