Executive Director - Clinical Development
$290k - $315k+ Bonus + Equity
Expert
MD
Boston, MA, USA
HybridEmployees work at least three days on-site each week.
Biology & BiotechClinical Research Operations
About the job
Requirements
- A Medical Doctorate (MD or DO) is required.
- Advanced clinical training in Rheumatology is required.
- 15 or more years of previous experience in clinical or related research is preferred.
- A history of mentoring and/or directly managing individuals in a team-based matrix environment is required.
- Familiarity with International Council for Harmonisation (ICH), Good Clinical Practice (GCP), and relevant regulatory requirements is required.
- Experience interacting with medical monitors, development operations—including preclinical, clinical operations, regulatory affairs, and Quality Assurance—and clinical investigators is required.
Responsibilities
- Develop the clinical development strategy for the zugocaptagene-geleucel autoimmune program, including early- and late-stage study designs, protocols, investigator brochures, briefing books, other regulatory documents, and regulatory interactions.
- Mentor clinical development leads in developing individual clinical studies aligned with the clinical development plan, including authoring and reviewing clinical documents such as protocols, investigator brochures, electronic case report forms (eCRFs), informed consent forms (ICFs), and clinical study reports (CSRs).
- Review clinical trial safety and efficacy data, including medical monitoring, assess consistency and completeness, and provide assessments and recommendations.
- Build and maintain relationships with thought leaders, clinical investigators, and partners to inform study design and program direction.
- Serve as the clinical development lead for one or more studies.
- Communicate a clear overview of trial results.
- Collaborate with clinical operations, data management, statistics, safety, commercial, and regulatory affairs stakeholders to translate clinical protocols into operational deliverables.
- Review and synthesize scientific literature and competitive intelligence to support study and program strategy.
- Develop scientific and protocol training presentations for internal and external meetings, including site qualification and initiation, investigator meetings, and training materials.
- Drive and support preparation of scientific material for conference presentations or publications.
- Lead and oversee clinical development leads in authoring and revising regulatory submissions.
- Perform analyses and generate scientific slide decks based on clinical, translational, and other datasets.
Desired Qualifications
- Clinical or research experience in autoimmune CAR-T trials.
- A strong track record of drug development in an industry setting.
- A proven history of effectively guiding and developing clinical development colleagues.
About the company
CRISPR Therapeutics develops gene-editing medicines using CRISPR/Cas9 to treat serious diseases. It edits genes in human cells, either ex vivo or in vivo, to correct disease-causing mutations, focusing on sickle cell disease, cancer, and other genetically defined conditions. The company supports its pipeline through partnerships and licensing in addition to internal R&D and clinical work, rather than relying solely on in-house development. Its goal is to deliver durable, disease-modifying therapies that meet unmet medical needs for patients worldwide through a global biopharmaceutical strategy.
Company Size
201-500
Company Stage
IPO
Headquarters
Switzerland
Founded
2013
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Simplify's Take
What believers are saying
- FDA approved CASGEVY for children age 2+, expanding eligibility by roughly 5,500 patients.
- Germany reimbursement on May 6, 2026 broadens access and supports European uptake.
- Phase 1 starts for CTX340 and CTX460 create multiple new catalysts in 2026.
What critics are saying
- CASGEVY revenue was only $76 million in Q2 2026, while losses hit $91.2 million.
- Broad won another March 2026 PTAB ruling; CRISPR's CRISPR-Cas9 foundation remains legally fragile.
- If slow patient starts persist through 2027, CRISPR's cash burn outlives CASGEVY commercialization.
What makes CRISPR Therapeutics unique
- CASGEVY is the first approved CRISPR/Cas9 therapy, with 39-country authorization by August 2026.
- CRISPR built a deep in vivo pipeline: CTX310, CTX340, CTX321, and CTX460.
- Vertex partnership monetizes CASGEVY globally, while CRISPR retains exposure to upside royalties.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account/Flexible Spending Account
- Unlimited Paid Time Off
- Flexible Work Hours
- Hybrid Work Options
- Stock Options
- 401(k) Retirement Plan
- Wellness Program
- Mental Health Support
- Gym Membership