Paralegal, Senior Contracts Manager

Position Summary:

The Crinetics Legal Team is seeking an experienced pharmaceutical/biotechnology paralegal with strong contracting expertise supporting research and development as well as commercial issues within the pharmaceutical industry. This individual will have deep experience supporting global pharmaceutical business issues, including clinical trial supply and study agreements, contract manufacturer agreements, and related supporting contracts necessary for product research, and development throughout the supply chain.  This position is expected to oversee a high volume of contracts and to collaborate within the Legal team and a variety of departments on to ensure the contracts are completed in a timely manner and in compliance with our policies.

As a key member of the Legal Team, this individual will support a broad range of contracts across various departments, with emphasis on our clinical operations, CMC and other R&D functions.  This person will also work independently, and collaborate cross-functionally with internal stakeholders on a wide variety of general contracts, , including without limitation, commercial supply agreements, agreements for Investigator Initiated Studies, MTAs, and Advisory Board Agreements. This position requires experience with contract lifecycle management systems and best practices to manage contract workflows, approvals, and document storage. This is a San Diego-based on-site/hybrid role with three days a week required in our corporate headquarters.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Draft, review, negotiate and manage all important details of an agreement, including key deliverables, milestones, dates, deadlines, and opt-out/negotiation windows, and termination or cancellation requirements.
• Work closely with attorneys, the finance department and business personnel to support the timely initiation, negotiation, review, execution, and administration of contracts.
• Take ownership and draft, review and negotiate various service agreements, including but not limited to, Confidentiality Agreements, Master Service Agreements, Statements of Work, Consulting Agreements, Amendments, commercial supply agreements, MTAs, LOIs, etc.
• Collaborate with internal stakeholders to participate in the development of RFPs and proposal reviews and ensure alignment with contract strategies and business objectives.
• Ensure contract consistency with current guidance and/or policy; review, draft, and document suggested language changes, and oversee resolution of all proposed changes to agreements
• Identify and resolve routine and moderately complex legal matters within area of responsibility with minimal supervision.
• Develop knowledge of Crinetics R&D business and quickly identify issues for appropriate escalation within the business, finance, compliance or legal.
• Liaise with procurement and Finance to ensure appropriate and required information is communicated between Finance, procurement and Legal.
• Support contract lifecycle management processes ensuring proper use of the CLM system for contract intakes, approvals, tracking and reporting.
• Lead and contribute to special projects related to contract management and process improvements, including the development of new policies, templates, playbooks, standard operating procedures (SOPs), training materials, and other support documents to enhance efficiency and compliance.
• Identify and implement process improvements to streamline contract workflows, enhance automation within the CLM system, and improve collaboration between Legal and cross-functional teams.
• Perform special tasks and assignments as required by management.

Education and Experience:

Required:

• Paralegal certification or a Bachelor’s degree in a related field is required with 12 years professional experience.
• Minimum of 8 years of recent experience in the pharmaceutical industry providing direct legal with a strong focus on contracting for R&D, CMC and GxP governed functions.
• Contracting Excellence: 
  • (a) Lead the direct negotiations, manage amendments, and oversee site-level negotiations using approved playbooks and clause libraries, ensuring consistency and efficiency of contracts and provide oversight of the applicable amendments and site level negotiation using approved playbook and clause libraries; 
  • (b) Collaborate closely with internal stakeholders, including study sites, Clinical Operations, CMC, Supply Chain, and other R&D teams to facilitate timely and efficient contract execution. 
  • (c) Partner with site contracts team and other business functions to resolve contract issues efficiently, ensuring timely finalization with an acute appreciation that patients are waiting.
• Strong written and verbal communication skills, with the ability to manage projects, coordinate multiple priorities, and engage effectively across teams.
• Must have working knowledge of human subject protection laws, Federal Food, Drug and Cosmetic Act and related regulations, US and global privacy laws, and other applicable federal and state laws and appreciate the need to escalate issues governing the research and development of human therapeutics. Must also understand when to escalate legal or compliance concerns impacting pharmaceutical research and development.
• Must have experience supporting clinical development programs, including negotiating and managing contracts related to data sharing arrangements, clinical supply arrangements, and complex research collaborations.
• Proficient in the use of contract management systems, as well as legal technology tools, spreadsheets, databases and word-processing applications.
• Ability to establish credibility quickly, build strong relationships across departments and with external stakeholders, and serve as a trusted legal resource.
• High attention to detail, accuracy, and the ability to maintain consistency in contract terms, processes, and compliance requirements. Ability to contribute to special projects focused on process improvements, including developing new policies, training materials, templates, and automation solutions to enhance contracting efficiency.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

The Anticipated Base Salary Range: $129,000-$161,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.