About Q32 Bio
Alopecia areata has long been one of dermatology’s most emotionally devastating — and underserved — conditions. Q32 Bio is changing that. We are a clinical-stage biotechnology company advancing a potentially transformative therapy for alopecia areata, with a bold science-first approach and a pipeline built to make a lasting difference for patients who have waited far too long for real solutions.
This is a pivotal moment for Q32 Bio. With meaningful clinical momentum and a team that punches well above its weight, we are looking for an exceptional leader to help us carry this mission across the finish line. If you want your work to matter — and to help bring a transformative therapy to patients — read on.
General Scope and Summary
Q32 Bio is searching for an Associate Director, Clinical Science to be the company’s scientific lead for clinical trial strategy and design for our bempikibart clinical development plan. This role serves as the study-level clinical scientist in immunology, with a focus on dermatologic indications, and is a core member of the Clinical Development team, which devises the program’s R&D scientific strategy and makes recommendations to the program team. The Associate Director will own the clinical science content of protocols, data review, and regulatory documents and serve as the scientific subject matter expert during study execution. The Associate Director will work across translational science, clinical pharmacology, data management, biostatistics, regulatory affairs, and clinical operations to make sure trials are scientifically rigorous, interpretable, and positioned for regulatory success. This role will report directly to the Senior Vice President, Clinical Development.
KEY RESPONSIBILITIES
Clinical Development Strategy
- Contribute to the bempikibart clinical development plan and translate program strategy into studylevel design decisions.
- Develop and present scientific recommendations to the Clinical Development team
- Maintain a working command of the competitive and scientific landscape in alopecia areata and immunology indications, and translate it into design and positioning implications.
Trial Design and Protocol Development
- Lead protocol development and amendments, including scientific rationale, objectives and endpoints, eligibility criteria, and schedule of assessments.
- Collaborate with translational science and clinical pharmacology to integrate biomarker, PK/PD, and dose rationale into study design.
- Partner with biostatistics on estimand strategy, endpoint justification, and study design elements.
Study Documents
Develop and/or contribute essential study documents, including:
- medical monitoring plans
- statistical analysis plans
- informed consent forms
- case report forms
- clinical sections of the Investigator’s Brochure
- study and pharmacy manuals
- clinical study reports
Partner with data management on data collection strategy and CRF/eCOA design.
Study Execution and Data Review
Working with study team and contribute to ongoing cross-study clinical data review and surveillance, and identify trends with scientific implications.
- Serve as the scientific subject matter expert during study execution, and actively participate in study team meetings and vendor meetings.
- Serve as the clinical science interface to the Clinical Study Team, providing scientific direction on operational issues and escalating matters with scientific impact.
- Conduct ongoing blinded clinical data review, including safety data review in support of the medical monitor and pharmacovigilance, to ensure patient safety and data accuracy and integrity.
- Partner with data strategy team to use data visualization tools for data review and monitoring. Contribute to data cleaning through clinical review and query generation.
- Contribute to risk-based quality management, including identifying critical data and processes and reviewing KRIs and QTLs.
- Review protocol deviations to analyze trends, identify risks, and implement mitigation strategies. Evaluate deviation trends escalated from the Clinical Study Team for impact on data integrity and interpretability.
- Support data monitoring and safety monitoring committee activities, including charter development, data package preparation, and open-session participation.
- Support database lock readiness for key readouts & interpret emerging efficacy data for the sub team.
- Contribute to statistical analysis plans and clinical study reports,
Regulatory and Scientific Communications
- Author the clinical content of health authority submissions and briefing packages and support IRB/EC and regulatory submissions and query responses.
- Contribute to integrated summaries, and clinical sections of regulatory dossiers.
- Support scientific communications, including abstracts, presentations, and manuscripts, in coordination with Medical Strategy.
- Support engagement with investigators, KOLs, and scientific advisory boards on trial design and data interpretation.
Cross-Functional Leadership
- Oversee CRO and vendor scientific deliverables.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- Bachelors degree plus advanced degree (PhD, PharmD, or MD) in a relevant life science or clinical discipline
- 5+ or more years of biopharmaceutical industry experience in clinical development, with at least 3 years in a clinical science or clinical research leadership role.
- Experience in a small to mid-size biotech environment that requires both strategic and direct handson contribution.
- Demonstrated end-to-end ownership of Phase 2 and/or Phase 3 trial design and execution, including protocol authorship and data review through database lock.
- Experience authoring clinical content for regulatory interactions and submissions.
- In-depth understanding of clinical development processes, regulatory requirements, and guidelines, including FDA, EMA, ICH, and GCP. Working knowledge of ICH E6(R3), the ICH E9(R1) estimand framework, and risk-based quality management principles.
- Strong critical thinking, problem-solving, and medical writing skills.
- Strong ability to interpret clinical, biomarker, and PK/PD data and to communicate scientific recommendations to senior governance forums.
- Experience in immunology, dermatology, or autoimmune disease
- Familiarity with alopecia areata endpoints such as SALT, and with the JAK inhibitor regulatory precedent in this indication.
- Experience with multiregional clinical trials, including APAC.
- Experience with biologics development, including immunogenicity considerations.
- Experience working with all levels of management and consulting with cross functional company stakeholders
- Strong interpersonal skills and the ability to effectively work with others
- Must be able and excited to work in person a minimum of 3 days per week at company headquarters in Waltham, MA in accordance with company in-office hours/schedule. Ability to travel, in some cases, internationally.