Clinical Contracts Manager - Legal

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking a Clinical Contracts Manager to join a high performing and growing legal team at Apogee. Reporting to our Executive Director, R&D Attorney, you will have the opportunity to work side-by-side with all clinical functions including clinical development, clinical operations, biometrics, etc. As a trusted partner to our clinical teams, you will play a pivotal role in the contracting process so we can get new trials started and bring better medicines to patients more quickly!

Key Responsibilities 

• Provide contract management support across all functions of our clinical organization.
• Maintain accurate and up-to-date records in our contract management system (Agiloft); maintain additional contract timeline trackers.
• Review CRO site agreement trackers and communicate with CROs to ensure the timely follow-up with sites.
• Facilitate timely and efficient negotiation and execution of study contracts and start-up of clinical trials.
• Collaborate with other departments for contract negotiation and budget review.
• Keep stakeholders informed of contract progress through clear and timely updates
• Negotiate site confidentiality agreements using fallback documentation; escalate as needed.
• Work closely with all members of the legal team and in close collaboration with our Legal Operations Manager to coordinate the maintenance of contract templates, provide coverage as needed for provision of first-draft contracts to vendors and provide training on legal processes and requirements.
• Participate in the low-risk resolution of contract-related issues as they arise and escalate to Clinical Contracts Attorney as needed.
• Actively seek to identify ways to improve processes, procedures and tools to enhance efficiencies in the clinical contracting process.
• Participate in special projects and initiatives within the Legal Department.
• Actively contribute to maintaining a solid legal team through participation in discussions, sharing best practices and collaboration on projects.
• Foster strong and collaborative relationships with legal and non-legal colleagues who contribute to the company’s drug development efforts.
• Develop a thorough understanding of and familiarity with the company’s business and use that knowledge in providing guidance and counsel to internal clients.
• Contribute to cultivating a company culture that reflects a strong commitment to ethics and patients and Apogee’s C.O.R.E.  values of caring, original, resilient and egoless.

Ideal Candidate 

• Undergraduate degree and/or paralegal certification required.
• 5+ years of life sciences industry experience.
• At least 3 years managing clinical contracts (CDA's, CTA's, etc).
• Proficiency with contract lifecycle management tools and e-signature applications, Agiloft and DocuSign preferred.
• Strong understand of clinical trial agreements, site confidentiality agreements, informed consent forms, and other clinical trial agreements; ex-US experience preferred but not required; experience with expanded access programs also preferred but not required.
• Mature and professional demeanor with a high degree of self-motivation and high integrity.
• Ability to collaborate with colleagues; experience collaborating with contract research organizations involved in clinical trials; experience working directly with sites preferred but not required.
• Ability to work independently and handle multiple priorities in a fast-pa