The
Head of Clinical Development leads Every Cure's clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement and oversees regulatory strategy and dissemination. The HCD supports Every Cure's CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.
How you will make an impact: Strategic Leadership of Clinical Development and Medical Affairs- Set the direction for Every Cure's clinical research and development, ensuring alignment with the organization's mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
- Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
- Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.
Research and Clinical Development Oversight- Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
- Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
- Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
- Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).
Portfolio Strategy and Program Management- Partner on strategic prioritization and dynamic management of Every Cure's diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
- Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
- Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.
Leadership and Team Development- Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
- Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
- Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.
Stakeholder Engagement, Compliance, and Dissemination- Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization's mission and sharing results from preclinical and clinical programs.
- Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
- Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
- Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.
What you bring to the team:Education - MD or MD/PhD preferred; PhD DO, or PharmD acceptable
Work Experience (Two-Tier: Head of / VP) - Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
- Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
- Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
- Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
- Experience working across more than one therapeutic research area.
- Experience with small-sample trial designs and natural history or registry data.
- Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.
Preferred for Vice President designation: - 12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.
Skills - Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
- Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
- Exceptional communication and presentation abilities.
- Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
- Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
- Strategic thinker with a focus on urgency, efficiency, and impact.
- Passionate about Every Cure's mission and values.
- Highly adaptable, thriving in a fast-paced, start-up environment.
- Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.
Compensations & Benefits: - Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually.
- Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses.
- Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future.
- Relax and recharge: Generous time off, including paid time off and paid holidays.
- We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times.
This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office. 
