Senior Medical Director, Clinical Development, Hematology

Beam Therapeutics; Cambridge (MA); On-site; USD 180,000 - 220,000; Full time

Job summary

A leading biotechnology company in Cambridge seeks a Senior Medical Director in Clinical Development. This role involves leading clinical strategies for base editing gene therapies, focusing on hematology. The ideal candidate will have extensive experience in clinical development, medical monitoring, and a strong background in hematology/oncology.

Qualifications

• 15+ years of experience in clinical development and medical monitoring.
• At least 5 years in the pharmaceutical/biotech industry.

Responsibilities

• Drive program and clinical strategy for assigned indications.
• Act as medical monitor for studies, ensuring patient safety.
• Contribute to regulatory documents for submissions.

Skills

Communication

Teamwork

Independent Work

Education

MD, DO, or equivalent degree

Job description

Beam Therapeutics is a biotechnology company committed to establishing a leading, fully integrated platform for precision genetic medicines. Beam has developed a platform that includes gene editing and delivery technologies and is building internal manufacturing capabilities. Its gene editing technology, base editing, enables precise, predictable, and efficient single-base changes at targeted genomic sequences without double-stranded DNA breaks. This technology supports diverse therapeutic editing strategies, advancing a portfolio of base editing programs. Beam is a values-driven organization dedicated to its people, cutting-edge science, and providing lifelong cures for serious diseases.

Position Overview:

The Senior Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies targeting hematology, specifically sickle cell disease and beta-thalassemia, using novel conditioning and/or in vivo approaches. The role involves working with multidisciplinary study teams on clinical development strategy, trial design and execution, medical monitoring, and supporting global regulatory interactions. Level will be commensurate with experience.

Responsibilities:

1. Serve on cross-functional teams to drive program and clinical strategy for assigned indications.
2. Co-lead the Clinical Development Sub-team to guide program strategy toward registration.
3. Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).
4. Act as medical monitor for studies, including design, execution, and data interpretation.
5. Contribute to study documents and analysis plans, such as ICFs, CRFs, SAPs, and biomarker analysis plans.
6. Ensure patient safety and adherence to Good Clinical Practices (GCP).
7. Contribute to regulatory documents for submissions, including INDs, CTAs, safety reports, and responses to authorities.
8. Coordinate with internal groups and external investigators, representing Beam during meetings and advisory boards.
9. Assist in planning Advisory Board meetings in relevant therapeutic areas.

Qualifications:

• MD, DO, or equivalent degree with 15+ years of experience.
• At least 5 years of experience in clinical development and medical monitoring within the pharmaceutical/biotech industry or as an investigator.
• Board certification or eligibility in hematology/oncology or related specialty is preferred.
• Strong communication skills to influence and collaborate effectively.
• Ability to work independently and in team-based, fast-paced environments.
• Experience in rare diseases, cell & gene therapy is a plus.