Agency Temporary, Contracts Counsel

Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in USA
Remote
78-97 Hourly
Senior level
Healthtech • Biotech
The Role
Provide legal support for clinical research by drafting, reviewing, and negotiating Clinical Trial Agreements and related vendor and commercial contracts. Ensure compliance with FDA, GCP, HIPAA, GDPR and other regulations; develop templates, SOPs, and negotiation playbooks; advise internal stakeholders on risk mitigation; assist with informed consent review; deliver training and lead process-improvement and cross-functional projects.
Summary Generated by Built In

NantWorks (the “Company”) is the parent company of various private and public entities that are changing how we work, live and play. We focus on three main categories: life sciences; energy & renewables; and media & technology. We invest in strategies that improve our core capabilities and in brand new industries, poised to change mankind for the better. By capturing tomorrow’s opportunities through scientific processes and entrepreneurial philosophies, we are at the forefront of emerging high-growth technologies across a wide range of industries.

 

The Company is a mandatory vaccination employer for COVID-19 and its variants.   The Company requires that its employees be fully vaccinated as of their start date.  If you require a medical or religious accommodation we will engage in the interactive process with you.  Proof of vaccination will be required prior to start.  If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date.  The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

Position Summary

The Contracts Counsel will be responsible for drafting, reviewing, and negotiating a wide range of contracts, with a primary focus on Clinical Trial Agreements (“CTAs”).  The role will apply  a robust understanding of the laws and regulations governing clinical trials while providing pragmatic legal advice that balances business objectives with risk mitigation.

Essential Functions

  • Draft, review, and negotiate complex CTAs, master service agreements (MSAs), confidentiality agreements, material transfer agreements, and vendor service agreements with research sites, and third-party vendors.
  • Review, draft, and negotiate a variety of non-clinical vendor agreements, including consulting agreements, master services agreements for general business support (e.g., IT, marketing, facilities), and supply agreements.
  • Ensure all clinical trial contracts and processes comply with applicable federal, state, and international laws and regulations, including FDA regulations, Good Clinical Practice (GCP) guidelines, and data privacy laws (e.g., HIPAA, GDPR).
  • Collaborate with internal stakeholders to develop, update, and maintain standard agreement templates and negotiation "playbooks" to improve efficiency and consistency.
  • Identify potential legal risks within contractual agreements and communicate these risks to internal decision-makers, offering mitigation strategies.
  • Assist with the legal aspects of patient informed consent forms (ICFs) to ensure participant protection and compliance.
  • Stay current with changes in legislation and regulatory environments affecting clinical research and integrate updates into company templates and processes.
  • Design and deliver internal training on R&D legal best practices; maintain templates/playbooks and lead process‑improvement initiatives.
  • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
  • Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Education & Experience

  • Juris Doctor degree from an accredited law school is required.
  • Active member of a State Bar Association (preferably California) required.
  • 5+ years of experience at a large law firm and/or the legal department of a Life Sciences or Pharmaceutical company required.

Knowledge, Skills, & Abilities

  • Understanding of statutes, regulations, and industry standards governing GxP, clinical research, trial transparency, and product commercialization
  • Excellent oral and written communication skills
  • Excellent organizational skills
  • Demonstrates discretion and ability to maintain confidentiality of information
  • Demonstrated expertise in drafting and negotiating clinical trial-related agreements and a strong understanding of the clinical development process.
  • Proven ability to handle a wide range of general corporate and commercial contracts beyond the clinical context.
  • In-depth knowledge of federal, state, and, preferably, international laws and regulations governing clinical research (e.g., FDA, GCP, ICH guidelines, data privacy regulations).
  • Ability to interpret and apply such laws, regulations and policies to inform business activities
  • Integrity and ethics, adaptability, innovation/creativity
  • Analytical thinking, negotiation skills, and decision-making skills

Working Environment / Physical Environment

  • This position works remotely.
  • Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval.

This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

 

National Market (all markets unless identified as Premium)

$77.50 (entry-level qualifications) to $85.25 (highly experienced) hourly

 

Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)

$88.50 (entry-level qualifications) to $97.35 (highly experienced) hourly

 

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

This is the pay range the Company reasonably expects to pay for this position at the time of this posting. Compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position.

Skills Required

  • Juris Doctor degree from an accredited law school
  • Active member of a State Bar Association (preferably California)
  • 5+ years experience at a large law firm and/or the legal department of a Life Sciences or Pharmaceutical company
  • Experience drafting, reviewing, and negotiating Clinical Trial Agreements (CTAs) and clinical trial-related contracts
  • Knowledge of FDA regulations, Good Clinical Practice (GCP), ICH guidelines, and clinical research regulatory frameworks
  • Knowledge of data privacy laws (e.g., HIPAA, GDPR) as they apply to clinical research
  • Experience with MSAs, confidentiality agreements, material transfer agreements, vendor service agreements, and general corporate/commercial contracts
  • Excellent oral and written communication skills; strong organizational skills; ability to maintain confidentiality
  • Ability to interpret and apply laws, regulations, and policies to inform business activities and provide pragmatic legal advice
  • Fully vaccinated for COVID-19 as of start date (medical or religious accommodations considered)
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The Company
HQ: El Segundo, CA
547 Employees

What We Do

ImmunityBio, Inc. (formerly NantKwest, Inc.) is developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. The activation of the innate immune system is key to the development of immunological memory. Over the last two decades, our founder and Executive Chairman Dr. Patrick Soon-Shiong has investigated mechanisms to activate the immune system to attack tumors that can otherwise evade and escape the body’s defense mechanisms. After inventing the world’s first protein nanoparticle drug, Abraxane, Dr. Soon-Shiong turned his focus to the next generation of immunotherapies. ImmunityBio was founded in 2014 to create innovative immunotherapies that address serious unmet needs in oncology and infectious diseases. "At ImmunityBio, we envision a day when we no longer fear cancer but are able to conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop remarkable new therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease." -Dr. Patrick Soon-Shiong, Executive Chairman

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