Senior Manager, Clinical Contracts Attorney - Keros Therapeutics
Lexington, MA
About the Job
Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF-ß signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
Job Summary: Reporting to the SVP, General Counsel and Corporate Secretary, the Clinical Trial Contracts Attorney will be a key member of the legal team who will facilitate the end-to-end lifecycle of Keros' clinical trial contracts, including the intake of new requests and reviewing and negotiating clinical trial contracts and related agreements.
Primary Responsibilities:
- Provide comprehensive legal support for various clinical agreements, including clinical trial agreements, confidentiality agreements, informed consent forms, site management agreements and other related contracts
- Offer guidance on clinical-related legal issues, including publications, inspections, and regulatory compliance, ensuring alignment with ethical standards and laws
- Collaborate with clinical operations and clinical development leaders, develop a strong understanding of their strategic objectives, and act as a thought partner for them to achieve their goals
- Liaise with internal teams and external partners to negotiate, draft, and review agreements, ensuring they meet the organization's objectives and compliance requirements
- Provide support for privacy/data protection related matters in the context of clinical trials. This includes advising and reviewing data processing agreements and related agreements
- Maintain electronic copies of clinical trial-related contract files and assure that signed contracts are accurately reflected in contract database
- Work closely with business colleagues in preparing guidance and training materials to support the efficient and compliant negotiation of agreements in the United States and abroad
- Provide ongoing support in day-to-day functions for legal department involving clinical trial contracts and related operations
- Other ad hoc projects, including supporting the review and negotiation of non-clinical trial-related contracts, amendments, renewals and terminations (Master Service Agreements, Confidential Disclosure Agreements, Consulting Agreements, Clinical Trial Agreements, Material Transfer Agreements, License Agreements, Sponsored Research Agreements, etc.), as deemed appropriate
Attributes:
- Commitment to operating in a highly regulated environment and industry, which requires understanding of the need for compliance with company policies, procedures and other relevant internal or external laws and regulations
- Must understand contract law and have effective communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions
- Strong analytical and problem-solving capabilities and skills
- Attention to detail and great follow-up skills are essential
- Strong time management, prioritization and organizational skills
- Demonstrable orientation toward process and management
- Willingness to partner with others and a proven track record of collaborative work relationships
Qualifications:
- JD from an accredited law school and member in good standing of the Massachusetts bar or the ability to obtain a limited in-house counsel registration in Massachusetts
- 5+ years of experience as a practicing attorney working in clinical trial contract negotiation and administration in the biotechnology/pharmaceutical or related industry
- Expertise in clinical agreements and a strong understanding of data privacy (including GDPR and U.S. privacy laws)
- Demonstrated ability to multi-task, problem-solve and operate in a fast-paced environment, particularly the ability to process complex sets of information and to effectively respond to rapidly changing priorities and deadlines
- Excellent interpersonal communication and negotiation skills, including both oral and written communication skills
- Commitment to accountability, reliability and responsiveness to successfully engage with a cross-functional team
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
