Associate Director Clinical Contracts

Zentalis Pharmaceuticals, Inc.; San Diego (CA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Zentalis Pharmaceuticals, Inc. is seeking an Associate Director of Clinical Contracts to support and maximize efficiency in contract negotiations related to clinical trials.

This role focuses on site-facing contracts, clinical trial agreements, confidentiality agreements, informed consent forms, and data access agreements, under the Executive Director, Legal Affairs. The candidate will draft and review agreements, identify risks, and collaborate with Clinical Operations, Regulatory, and vendors

Qualifications

• 5-8 years relevant industry experience, with at least 4 years industry experience in independent contract negotiation and contract drafting.
• Experience negotiating international contracts.
• Strong drafting skills a must.
• In-house experience in biotech/pharma environment with site experience preferred.
• Excellent problem solving and negotiation communication abilities.
• Knowledge of privacy laws, GDPR preferred.
• Ability to meet deadlines and prioritize work.
• Ability to work independently and collaboratively.

Responsibilities

• Draft, analyze, and review clinical operations contracts and related documents.
• Identify risks and provide actionable mitigation recommendations.
• Interface with Clinical Operations, Regulatory, and stakeholders to resolve issues.
• Assist in developing clinical trial-related policies and procedures.
• Maintain accurate clinical operations document repository.
• Assist with negotiation and management of non-clinical operations documents.
• Review privacy language and IP concerns in agreements.
• Prepare reports, presentations, and training materials.

Skills

Contract drafting

Contract negotiation

In-house legal experience

International contracts

Privacy laws knowledge

GDPR knowledge

Communication skills

Excel

PowerPoint

Deadline management

Education

BA/BS or MS

Tools

MS Office

Contract management software

Job description

ASSOCIATE DIRECTOR CLINICAL CONTRACTS

Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer andmultiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis isadvancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.

POSITION SUMMARY:

Serving as an important member of a collaborative and dynamic team, this individual will assist the Company in achieving its business objectives by helping to support and maximize the efficiency of the legal contract negotiations. This position will be primarily responsible for supporting negotiation of clinical trial site-facing contracts and other legal documents needed during study start-up, such as clinical trial agreements, confidentiality agreements, informed consent forms, data access agreements and for providing other support as requested for the contracting process. In addition, this person will help support the negotiation of other contract types, as requested, such as consulting agreements, work orders and contract amendments with vendors.This role reports to the Executive Director, Legal Affairs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support counsel for Clinical Operations with all aspects of clinical operations-related documents (domestic and international) by independently drafting, analyzing and reviewing legal previsions within a variety of documents, including confidentiality agreements, clinical trial agreements, informed consent documents and letters of authorization.
• Identify and appropriately elevate risks, assess potential impact of identified issues and provide well-reasoned recommendations and practical solutions to facilitate informed decision-making and risk mitigation in order to support contract negotiations and activities for assigned projects, teams and/or departments;
• Interface with Clinical Operations, Regulatory, and other internal and external stakeholders as required to resolve issues.
• Proactively identify opportunities to implement improved processes and to maximize efficiency of the legal team.
• Assist in the development of clinical trial-related policies and procedures.
• Ensure clinical operations document repository is accurate and up to date.
• Assist with the negotiation and management of non-clinical operations documents, as needed.
• Understanding of privacy laws as they relate to a biotech pharmaceutical company, including GDPR, to support the Company’s privacy program and to be able to review privacy language as it arises in contracts and other legal documents.
• Ability to identify potential intellectual property concerns in agreements and escalating those concerns to intellectual property counsel preferred.
• Prepare reports, spreadsheets, presentations and training materials.
• Knowledge of privacy laws, particularly GDPR is preferred.
• Experience with pharmaceutical supply agreements and agreements relating to commercialization of approved drugs is a plus.
• Other projects and assignments, as needed.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• BA/BS or MS from an accredited U.S. college.
• 5-8 years relevant industry experience, with at least 4 years industry experience in independent contract negotiation and contract drafting.
• Industry experience with negotiating and drafting international contracts.
• Strong drafting skills is a must.
• Industry experience negotiating confidentiality agreements, Work Orders.
• Prior in-house experience as a member of a legal department or clinical operations department in a biotechnology or pharmaceuticals company in addition to site experience stronglypreferred.
• Excellent problem solving skillsand ability to strongly articulate and defend the Company’s positions in negotiations.
• Strong practical experience with Excel and PowerPoint.
• Ability to meet deadlines and prioritize work strategically.
• Knowledge of pharmaceutical and other relevant laws, regulations, and policies as well as industry standards to inform decision-making and business activities preferred.
• A demonstrated ability to collaborate, as well as to work independently, balancing competing priorities in a fast-paced, deadline-driven environment with a high level of professionalism.
• Highly effective communication skills (both verbal and written).
• Detail-oriented.
• Ability to handle confidential and proprietary information using discretion and judgment.
• Self-motivated, able to work independently and be reliable and responsive.
• Personable, with ability to work well with Legal Department colleagues and internal Company clients.
• Ability to be flexible, with an interest in learning and willing to accept new responsibilities as needed.