Director/Sr. Director, Clinical Data Management

Damora Therapeutics; Massachusetts; On-site; USD 150,000 - 210,000; Full time

Job summary

Damora Therapeutics is seeking a Director of Clinical Data Management to own end‑to‑end data handling for first‑in‑human oncology programs. You will collaborate with Clinical Operations, Translational Medicine, Safety, and Biostatistics to enable rapid, safety‑driven decision making in a lean biotech setting.

You will manage data management activities from protocol development through database lock, oversee CRO/vendors, ensure GCP/GCDMP/CDISC compliance, and drive inspection readiness for

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 10–12+ years of hands‑on clinical data management experience.
• Extensive experience supporting first‑in‑human and early‑phase oncology trials.
• Proven ability to operate independently in a lean or startup biotech environment.
• Strong hands‑on experience managing CROs and specialized vendors.
• Direct experience supporting INDs and regulatory interactions.
• Expert knowledge of EDC systems (Medidata Rave, Veeva), CDISC standards, and global regulations.

Responsibilities

• Serve as the primary data management lead for first‑in‑human oncology trials.
• Partner during protocol development to ensure fit‑for‑purpose data collection for safety, PK/PD, biomarkers, and emerging efficacy signals.
• Author and maintain core deliverables, including Data Management Plans, data review plans, and risk‑based quality strategies.
• Lead database design, eCRF development, edit check specification, and UAT, with flexibility to accommodate protocol amendments.
• Oversee data review through interim analyses and database lock.
• Lead data management input into CRO and vendor selection and scope definition.
• Act as primary data management point of contact for CROs and early‑phase vendors.
• Perform hands‑on oversight of deliverables, timelines, and data quality.
• Review and approve validation documentation, interim data cuts, and database locks.

Skills

Clinical data management

Data quality management

Regulatory interactions

CRO/vendor management

IND support

EDC systems: Medidata Rave, Veeva

CDISC standards

Education

Bachelor’s degree in life sciences or related field; advanced degree preferred

Tools

Medidata Rave

Veeva

Job description

Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for new disease-modifying treatments. With multiple programs with best-in-class potential on track to enter clinical development in 2026, our goal is to rapidly bring forward optimized treatments with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes.

This is a unique opportunity to join a science-driven company at a formative stage, where early clinical data will directly shape development strategy and drive long-term value. The right candidate will join a team with significant early- and late-stage development experience, with the goal of quickly moving through dose escalation/expansion into pivotal trials.

The Role

The Director of Clinical Data Management is a senior individual contributor responsible for the hands‑on execution and delivery of high-quality, inspection-ready clinical trial data for first‑in‑human (FIH) oncology programs. This role provides end‑to‑end ownership of data management activities from protocol development through database lock, interim analyses, and regulatory interactions.

Operating in a lean biotech environment, this position requires deep early‑phase oncology expertise, independent judgment, and close collaboration with Clinical Operations, Translational Medicine, Safety, and Biostatistics to support rapid, safety‑driven decision‑making.

What You’ll Do

FIH Study Execution

• Serve as the primary data management lead for first‑in‑human oncology trials.
• Partner during protocol development to ensure fit‑for‑purpose data collection for safety, PK/PD, biomarkers, and emerging efficacy signals.
• Author and maintain core deliverables, including Data Management Plans, data review plans, and risk‑based quality strategies.
• Lead database design, eCRF development, edit check specification, and UAT, with flexibility to accommodate protocol amendments.
• Oversee data review through interim analyses and database lock.
• Lead data management input into CRO and vendor selection and scope definition.
• Act as primary data management point of contact for CROs and early‑phase vendors.
• Perform hands‑on oversight of deliverables, timelines, and data quality.
• Review and approve validation documentation, interim data cuts, and database locks.

Data Quality, Safety & Compliance

• Take direct accountability for data quality, timeliness, and inspection readiness.
• Oversee query management, data cleaning, and key reconciliations (AE/SAE, labs, PK).
• Manage medical coding activities (MedDRA, WHODrug).
• Ensure compliance with GCP, GCDMP, 21 CFR Part 11, CDISC standards, and global regulatory requirements.
• Support INDs, audits, inspections, and health authority interactions.

Cross‑Functional Collaboration

• Work closely with Clinical Operations on real‑time data review during dose escalation.
• Partner with Pharmacovigilance to ensure accurate and timely safety data.
• Collaborate with Biostatistics on interim analyses and decision‑critical data cuts.
• Support oncology‑specific data needs including biomarkers, genomics, imaging, and translational endpoints.

What You’ll Bring

• Bachelor’s degree in life sciences, computer science, or related field; advanced degree preferred.
• 10–12+ years of hands‑on clinical data management experience.
• Extensive experience supporting first‑in‑human and early‑phase oncology trials.
• Proven ability to operate independently in a lean or startup biotech environment.
• Strong hands‑on experience managing CROs and specialized vendors.
• Direct experience supporting INDs and regulatory interactions.
• Expert knowledge of EDC systems (e.g., Medidata Rave, Veeva), CDISC standards, and global regulations.
• Highly organized, adaptable, and comfortable operating with ambiguity.

At Damora Therapeutics, we offer competitive compensation and thoughtfully designed total rewards aligned with industry benchmarks. We believe in rewarding impact and building meaningful ownership for our team.

Agency Policy

We are building our team intentionally and do not accept unsolicited resumes from recruiting or staffing agencies. Agencies should not submit candidates unless directly engaged by Damora’s HR team and operating under a signed agreement. Any resume submitted without prior authorization and a signed agreement will be considered property of Damora Therapeutics, and no referral or placement fees will be paid.