Director/Sr. Director, Clinical Scientist
10+ years
Greater Boston
Full-time
Hybrid
1 month ago
About the role
The Role
We are seeking a Senior Director, Clinical Scientist to play a critical leadership role in the design, execution, analysis, and scientific oversight of our first-in-human clinical trials. This individual will serve as a senior scientific leader and key strategic partner to Clinical Development, Clinical Operations, Translational Science, Regulatory, Biometrics, and Safety, with significant responsibility for study-level strategy, scientific leadership, and cross-functional execution.
The Senior Director, Clinical Scientist will lead the development and authorship of key clinical and regulatory documents; drive ongoing clinical data review and interpretation; contribute to dose-escalation and development strategy decisions; and provide scientific leadership across internal governance and cross-functional forums. This individual will also help establish scalable clinical science processes and best practices as the organization grows.
This role reports to the Senior Vice President of Clinical Research Operations.
What You’ll Do
Clinical Science Leadership & Trial Execution
Cross-Functional Program Leadership
Data Review, Interpretation & Communication
External & Operational Excellence
What You Bring
We are seeking a Senior Director, Clinical Scientist to play a critical leadership role in the design, execution, analysis, and scientific oversight of our first-in-human clinical trials. This individual will serve as a senior scientific leader and key strategic partner to Clinical Development, Clinical Operations, Translational Science, Regulatory, Biometrics, and Safety, with significant responsibility for study-level strategy, scientific leadership, and cross-functional execution.
The Senior Director, Clinical Scientist will lead the development and authorship of key clinical and regulatory documents; drive ongoing clinical data review and interpretation; contribute to dose-escalation and development strategy decisions; and provide scientific leadership across internal governance and cross-functional forums. This individual will also help establish scalable clinical science processes and best practices as the organization grows.
This role reports to the Senior Vice President of Clinical Research Operations.
What You’ll Do
Clinical Science Leadership & Trial Execution
- Serve as lead Clinical Scientist on one or more Phase 1 first-in-human dose escalation trials in hematologic malignancies.
- Contribute strategically to the clinical development plan for mCALR targeting antibodies, including study design, dose-escalation strategy, and data interpretation.
- Lead the development, authorship, and review of key clinical and cross-functional documents, including protocols, amendments, IBs, eCRFs, completion guidelines, SAP TLF shells, and regulatory briefing materials.
- Drive dose-escalation and study conduct discussions through real-time review and interpretation of emerging safety, PK/PD, biomarker, and clinical data.
- Provide scientific leadership and recommendations in data review meetings, SRCs, governance forums, and cross-functional team discussions.
Cross-Functional Program Leadership
- Serve as a core scientific leader across cross-functional program teams, partnering closely with Clinical Operations, Translational Medicine, Regulatory, Biometrics, and Safety.
- Drive alignment and execution across functions to support high-quality and timely study delivery.
- Collaborate with Translational and Preclinical teams to integrate biomarker and mechanistic hypotheses into clinical studies and broader development strategy.
- Proactively identify and address scientific, operational, and strategic risks and gaps.
Data Review, Interpretation & Communication
- Lead ongoing review and interpretation of clinical data, including safety, efficacy, PK/PD, and exploratory biomarkers.
- Develop clear scientific insights and recommendations to inform development strategy and clinical decision-making.
- Contribute to regulatory submissions, health authority responses, internal governance materials, and external scientific communications.
- Support preparation of abstracts, posters, manuscripts, and presentations for scientific meetings and publications.
External & Operational Excellence
- Provide scientific leadership in interactions with investigators, CROs, vendors, and external experts to support high-quality trial execution.
- Lead or support investigator meetings and scientific training sessions.
- Ensure strong organization, follow-through, and proactive management of deliverables across assigned studies and workstreams.
What You Bring
- PhD, PharmD, MD, or equivalent advanced scientific degree required.
- 8+ years of experience in clinical research or clinical development within the biotechnology or pharmaceutical industry.
- Deep understanding of clinical trial design, clinical data analysis, and drug development principles, with direct experience leading or supporting early-phase (Phase 1 / FIH) clinical trials.
- Strong scientific foundation in hematology or oncology required; MPN experience strongly preferred.
- Demonstrated ability to independently lead complex scientific workstreams and influence cross-functional teams in a fast-paced biotech environment.
- Proven experience leading development and authorship of clinical and regulatory documents.
- Strong analytical and scientific interpretation skills, including the ability to synthesize emerging clinical, safety, and biomarker data into actionable insights.
- Excellent written and verbal communication skills, with the ability to clearly communicate complex scientific concepts to diverse audiences.
Skills
Pharmaceutical Manufacturing