Damora Therapeutics, Inc. (Nasdaq: DMRA) is a Boston-based biotechnology company working to fundamentally redefine care for patients with blood disorders. Damora is advancing a new generation of subcutaneous biologics targeting mutant calreticulin (mutCALR)-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis — chronic hematologic cancers with significant unmet need. The company’s lead program, DMR-001, is an investigational monoclonal antibody designed to selectively target mutant calreticulin, with additional programs (DMR-002 and DMR-003) advancing behind it.
As our trial footprint expands across multiple countries and regulatory jurisdictions, we are seeking an attorney to serve as legal counsel for clinical trial contracting and to ensure data privacy compliance is embedded throughout the clinical research lifecycle.
Position Summary
Reporting to the General Counsel, this attorney will provide legal counsel on clinical trial contracting and serve as the company's legal subject-matter expert on global privacy laws. The role leads negotiation of clinical trial agreements (CTAs) and related contracts with investigators, sites and CROs, and advises Damora’s internal teams on legal risk. The ideal candidate is a practicing attorney with 7+ years of in-house biotech, law firm and/or CRO experience, deep familiarity with international data protection frameworks, and comfort advising on a global, multi-jurisdictional trial portfolio.
Key Responsibilities
Clinical Trial Agreement Negotiation
- Serve as legal counsel for end-to-end negotiation and risk review of CTAs, confidentiality agreements and ancillary study agreements with clinical sites, investigators, CROs and vendors worldwide.
- Provide legal advice on contract risk, indemnification, liability, IP and budget terms, and clear escalations requiring senior legal or executive sign-off.
- Serve as the primary legal point of contact for sites and CROs throughout study startup, conduct, and closeout.
- Draft and maintain clinical trial template agreements, fallback positions, and negotiation playbooks; train non-legal stakeholders on contracting standards.
- Monitor changes in international clinical trial regulation (e.g., EU Clinical Trials Regulation/CTIS, ICH-GCP) and data privacy law, and advise the General Counsel on legal risk and mitigation strategy.
- Contribute to scalable global legal processes, templates, and training as the clinical portfolio expands into new regions.
Privacy & Data Protection
- Own the creation, implementation, and ongoing enforcement of Damora's global privacy policies and internal controls, including monitoring adherence across business units and driving corrective action where gaps are identified.
- Serve as the legal department's subject-matter expert on the intersection of global data privacy law (GDPR, UK GDPR, HIPAA, PIPL, LGPD, and other regional frameworks) and clinical trial operations.
- Draft, review, and negotiate data processing agreements (DPAs), international data transfer mechanisms (e.g., Standard Contractual Clauses), and privacy language in informed consent forms and protocols, providing formal legal sign-off.
- Lead privacy/data protection impact assessments (DPIAs) for clinical data flows, including genomic and biospecimen data, in partnership with the Legal Department and IT Security.
- Provide legal advice on cross-border data transfer restrictions and data localization requirements that affect trial design, vendor selection, and site feasibility.
- Act as a trusted legal advisor to Clinical Operations, R&D, Regulatory Affairs, Data Management, and IT Security, embedding legal and privacy considerations early in study planning.
Qualifications
Required
- J.D. from an accredited law school and active license to practice law (or equivalent qualification to practice) in good standing.
- 7+ years of relevant in-house biotech, law firm and/or CRO experience, including substantial hands-on experience negotiating clinical trial agreements and data protection agreements.
- Experience advising on or supporting multi-regional or global clinical trials across varied regulatory environments, including managing outside counsel, working with CROs and negotiating with sites, sponsors and vendors.
- Experience with applying regulatory guidance and global data privacy frameworks (GDPR, HIPAA, and comparable regional laws) to clinical research and biospecimen/genomic data.
- Strong contract drafting, redlining, and negotiation skills; sound legal judgment and ability to manage a high-volume matter load against tight timelines.
- Excellent client-counseling and cross-functional communication skills, with the ability to translate legal and privacy requirements for clinical and operational stakeholders.
Preferred
- Experience with contract lifecycle management (CLM) or CTMS platforms.
- Prior in-house experience at a clinical-stage biotech, pharmaceutical company, or CRO.
- Privacy certification (e.g., CIPP/E, CIPP/US).
Location & Travel
Hybrid or remote arrangements considered. Occasional domestic and international travel may be required.
#J-18808-LjbffrSr. Director, Clinical & Data Privacy Counsel in waltham at Unknown Company
This position is listed as contract and able to be worked remotely.