Clinical Contracts Manager - Legal

March 4

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• 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! • 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.

🎯 Requirements

• 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 understanding 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-paced environment and manage the expectations of internal clients with an appreciation of when to escalate issues and defer to other departments. • Exercise good judgment, attention to detail, a desire to learn, and an ability to take on and prioritize a wide variety of complex matters while meeting tight deadlines. • Excellent interpersonal skills, ability to communicate complex issues clearly and succinctly, relationship-building and influencer skills. • Strong attention to detail and organizational skills. • Position requires 10% travel to company and functional meetings.

🏖️ Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • Flexible PTO • Two, one-week company-wide shutdowns each year • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve