ASSOCIATE DIRECTOR CLINICAL CONTRACTS
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 escalate 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.
