Senior Manager, Contracts Management

Korro Bio, Inc.; Cambridge (MA); Sur place; USD 155 000 - 196 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

Vision coverage

401(k) retirement plan

Life insurance

Dependent care FSA

HSA/health savings account

Parking or MBTA pass

Résumé du poste

Korro Bio, Inc. seeks a Senior Manager, Contracts Management to lead drafting, negotiation, and management of clinical trial agreements and related contracts across global sites (US, Europe, Australia).

This role supports G&A and vendor activities and optimizes the CLM system for efficient study start-up. The ideal candidate has 8+ years in contracts management within biotech/pharma, strong negotiation skills, and thorough knowledge of ICH-GCP, EU CTR, GDPR, and HIPAA.

Qualifications

• Bachelor’s degree required; J.D., LL.B., or equivalent legal training or paralegal certification preferred.
• 8+ years of contracts management experience in biotech/pharma/CRO.
• Hands-on drafting and negotiating clinical trial agreements and site budgets globally (US, Europe, Australia).
• Experience negotiating with U.S. academic medical centers and research institutions.
• Knowledge of clinical research regulations: ICH-GCP, EU CTR, GDPR, HIPAA, Australian privacy requirements.
• Experience with a broad range of life sciences agreements (CRO, vendor, data processing, MTA).
• Experience with CLM systems, vendor selection, and RFP processes.
• Ability to manage high-volume contract portfolios and work across time zones.

Responsabilités

• Draft, review, negotiate, and manage CTAs and related contracts for global trials.
• Negotiate site budgets and payment terms in partnership with Clinical Operations and Finance.
• Apply jurisdiction-specific clinical trial knowledge (EU CTR, Medicines Australia, US institutions).
• Address indemnification, insurance, IP, publication rights, confidentiality, and data protection.
• Draft and negotiate ancillary agreements (NDAs, DPA, vendor, data, MTA).
• Develop and standardize CTA templates and negotiation playbooks; manage CRO site contracting.
• Oversee CLM system, workflows, approvals, and signature routing.
• Track cycle times and prepare contract metrics for leadership.
• Escalate material deviations and high-risk issues to Senior Director, Contracts Counsel.
• Maintain contract repositories and version control.

Connaissances

Contracts management

Clinical trial contracts

Negotiation

Regulatory knowledge

Stakeholder collaboration

Project management

Formation

Bachelor’s degree

J.D./LL.B./equiv. legal training

Outils

CLM systems

AI in contracting

RFP processes

Description du poste

Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is for Urea Cycle Disorders. Korro is based in Cambridge, Massachusetts. For more information, visit korrobio.com.

We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.

Position Summary

We are seeking an experienced Senior Manager, Contracts Management to join our Legal team as a full-time employee. This role will lead the drafting, negotiation, and management of clinical trial agreements and related clinical research contracts supporting our global clinical development programs, with global study sites, institutions, and vendors, including in the United States, Europe, and Australia. The role will also support the company’s general and administrative functions on confidentiality agreements, commercial agreements, and vendor selection, and will administer and optimize the company’s contract lifecycle management (CLM) system and workflows. The successful candidate will serve as a trusted contracting partner to Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Quality, Finance, and G&A functions, balancing speed to study start-up with sound legal and regulatory risk management.

Key Responsibilities

Clinical Trial Agreements & Global Contract Negotiation:

• Draft, review, negotiate, and manage clinical trial agreements (CTAs) and related clinical research contracts, including site and institution agreements, investigator-initiated study agreements, CRO master services agreements and work orders, and amendments, for global clinical trials, including trials conducted in the United States, Europe, and Australia.
• Negotiate study site budgets and payment terms in partnership with Clinical Operations and Finance, ensuring fair market value and alignment with protocol requirements.
• Apply working knowledge of jurisdiction-specific clinical trial frameworks and templates, including the EU Clinical Trials Regulation (EU CTR), Medicines Australia standard form agreements, and U.S. institutional and academic medical center requirements.
• Address key clinical contracting issues, including indemnification, insurance, subject injury, intellectual property, publication rights, confidentiality, and data protection (including GDPR, HIPAA, and the Australian Privacy Act).
• Draft and negotiate ancillary clinical and R&D agreements, including confidentiality agreements, data processing agreements, laboratory and vendor services agreements, consulting and HCP agreements, and material transfer agreements.
• Develop, maintain, and standardize CTA templates, budget templates, and negotiation playbooks with pre-approved fallback positions to accelerate study start-up timelines.
• Oversee CRO-delegated site contracting, including management of CRO contract teams, escalation pathways, and adherence to approved templates and fallback positions.
• Track contracting status and cycle times against study start-up milestones, and create, run, and distribute contract metrics and status reports for Legal and business leadership, proactively identifying and resolving bottlenecks.
• Coordinate contract execution, including e-signature routing to appropriate signatories in accordance with the company’s signature authority policy.
• Apply sound judgment in escalating material deviations and high-risk issues to the Senior Director, Contracts Counsel.
• Maintain contract repositories and ensure proper filing, version control, and accessibility of executed agreements and amendments.

Contract Operations & Business Partnership:

• Serve as the primary contracting partner to Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Quality, Finance, and G&A functions, including IT, HR, and Facilities, on contracting matters, identifying legal and regulatory risk.
• Draft, review, and negotiate confidentiality agreements and routine contracts supporting G&A functions, including software/SaaS, IT, facilities, professional services, and other vendor agreements.
• Partner with business stakeholders on vendor selection, including RFP support, vendor due diligence, and evaluation of contract terms and risk.
• Lead contract intake, tracking, and lifecycle management using the company’s contract lifecycle management (CLM) system, including designing, administering, and optimizing CLM workflows, intake forms, approval routing, and signature authority controls.
• Drive continuous improvement of contracting workflows, including evaluation and implementation of AI and legal technology tools to increase efficiency and consistency.
• Partner with Compliance on Healthcare Professional (HCP) contracting, anti-bribery and anti-corruption requirements (including the FCPA and applicable local laws), and transparency reporting requirements in the United States and other applicable jurisdictions.
• Develop and deliver training for business stakeholders on contracting processes, templates, and best practices.
• Monitor renewals, expirations, and terminations of executed agreements, and manage contract closeout at study completion.
• Manage relationships with local counsel in ex-U.S. jurisdictions, to resolve complex matters efficiently.
• Other tasks and duties as assigned.

Required Qualifications

• Bachelor’s degree required; J.D., LL.B., or equivalent legal training or paralegal certification preferred.
• At least eight (8) years of contracts management experience in an in-house legal or clinical contracting function at a biotech, pharmaceutical, or CRO organization, or at a law firm with a life sciences practice.
• Deep, hands-on experience drafting and negotiating clinical trial agreements and site budgets globally, including demonstrated experience with global studies, including in the United States, Europe, and Australia. Qualified candidates will be able to speak to multiple specific instances of this hands-on experience.
• Experience negotiating with U.S. academic medical centers and research institutions.
• Strong working knowledge of clinical research regulations and standards, including ICH-GCP, the EU Clinical Trials Regulation, GDPR, HIPAA, and Australian clinical trial and privacy requirements.
• Experience with a broad range of life sciences agreements, such as CRO, vendor, consulting, HCP, data processing, and material transfer agreements.
• Experience negotiating CDAs and general commercial agreements, including software/SaaS and services agreements.
• Experience supporting vendor selection processes, including RFPs and vendor due diligence.
• Experience configuring or administering contract lifecycle management (CLM) systems, including workflows and approval processes; CLM implementation experience a plus.
• Experience using AI and legal technology tools to improve contracting workflows.
• Proven ability to serve as a trusted business partner and independently manage a high-volume contract portfolio with competing priorities and study timelines.
• Excellent negotiation, written, and verbal communication skills, with the ability to explain legal risk clearly to non-legal stakeholders.
• Strong project management skills and ability to work across time zones with internal teams, CROs, and study sites.
• High level of discretion and ability to handle confidential information.
• Analytical mindset with strong judgment and problem-solving capabilities.
• Ability to work independently and as part of a collaborative team.
• Ability to be onsite at least 3 days per week, with or without reasonable accommodation.

$154,808 - $195,793 a year

Final salary will be determined by the level at which the role is filled and by factors such as skills, competencies, experience, education, and other job-related criteria permitted by law. This range reflects base salary only and does not include annual bonus or equity.

Korro Bio offers a competitive total rewards package, including equity-based compensation and comprehensive benefits:

• medical coverage
• dental coverage
• vision coverage
• 401(k) retirement plan
• life insurance
• dependent care flexible spending account
• company-funded health savings account
• complimentary parking or a MBTA commuter pass