Lead clinical development planning and execution for engineered-organ programs. Design protocols, oversee study conduct and data review, support regulatory submissions, collaborate cross-functionally, and drive process improvements to ensure scientific rigor and operational excellence.
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
The Associate Director, Clinical Science is responsible for the planning, execution and operational oversight of clinical development programs supporting the advancement of eGenesis’ pipeline. Working with cross-functional teams, this role will ensure the scientific integrity, operational excellence and timely execution of clinical studies. The successful candidate will contribute to the design and execution of clinical development strategies, support regulatory submissions, and drive continuous improvement across clinical development processes and initiatives in a collaborative, science-driven biotech environment.
PRIMARY RESPONSIBILITIES
- Support the design and implementation of early and late-stage clinical projects and ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous
- Develop and maintain clinical development plans that integrate preclinical, translational, and clinical data while ensuring alignment across cross-functional teams
- Design scientifically rigorous, operationally feasible, and cost-effective clinical protocols aligned with the overall clinical development plan
- Present clinical protocols, development plans, and study updates to internal governance committees and senior leadership
- Serve as the Clinical Science representative on cross-functional project teams
- Partner closely with the Medical Monitor to oversee study conduct, monitor study progress, and ensure protocol compliance
- Lead data review, evaluation, and analyses in collaboration with Data Management and Biostatistics and Statistical Programming teams
- Contribute to the preparation of clinical sections of regulatory submissions and supporting documents, including INDs, briefing documents, BLAs, Safety and Annual reports, and responses to regulatory agencies regarding questions about clinical development issues (e.g., safety or efficacy)
- Ensure compliance with applicable regulations, clinical R&D policies, SOPs and quality standards
- Support scientific due diligence activities, including preparing and presenting medically-sound strategies and plans associated with advanced opportunities
- Drive continuous improvement to enhance Clinical Development processes, study execution and cross-functional collaboration
QUALIFICATIONS
- PharmD or PhD with 7+ years of clinical science experience in a biotech or pharmaceutical company, or CRO environment
- Experience in clinical development and/or translational science required
- Strong understanding of clinical trial design, data collection standards, and GCP guidelines
- Strong analytical skills with the ability to analyze and compile complex clinical data
- Strong experience working with vendors and clinical sites
- Excellent communication and collaboration skills with both internal teams and external partners
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
- Excellent oral and written communication skills, including proficiency with Excel and PowerPoint
Base pay range for this job is $175,000 - $226,000.
eGenesis Boston, Massachusetts, USA Office
Boston, MA, United States
Similar Jobs
Artificial Intelligence • Automotive • Greentech • Information Technology • Machine Learning • Software • Cybersecurity
Manages a portfolio of automotive dealership clients, driving product adoption, revenue retention, upgrades, and account growth. Builds client relationships, identifies risks, resolves complex issues, analyzes performance, recommends improvements, and supports client business objectives. Conducts virtual engagements and occasional onsite visits, provides product training, collaborates internally, mentors newer managers, and participates in workshops, webinars, vendor events, and special projects. The regional role covers Connecticut, Rhode Island, Massachusetts, and surrounding states.
Top Skills:
Microsoft Office SuiteScreen Sharing SoftwareWeb-Based Systems
Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
Own end-to-end business systems analysis for Salesforce CPQ, Revenue Cloud, and the Quote-to-Cash ecosystem. Gather requirements, define processes, conduct fit-gap analysis, design scalable solutions, plan and execute testing, document workflows, train users, and provide post-launch support. Analyze data, assess downstream impacts, facilitate Agile ceremonies, and use AI tools and Salesforce AI capabilities to accelerate delivery and improve seller and partner experiences.
Top Skills:
AgentforceApexEinsteinLightning Web Components (Lwc)SaaSSalesforceSalesforce CpqSalesforce FlowSalesforce Revenue CloudSOQL
Artificial Intelligence • Consumer Web • Edtech • Enterprise Web • HR Tech • Social Impact • Generative AI
Design and manage end-to-end creative workflows, cross-functional programs, resource planning, agency partnerships, governance, and creative technology systems. Lead timelines, dependencies, stakeholder alignment, change management, KPI tracking, budget efficiency, and vendor relations to deliver high-quality creative work on time and within budget.
Top Skills:
AirtableAsanaDigital Asset Management (Dam) SystemsJIRAMartech
What you need to know about the Boston Tech Scene
Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories
