Senior Director, Cell Therapy Clinical Safety

BlueRock Therapeutics; Cambridge (MA); Hybrid; USD 310,000 - 365,800; Full time

Job summary

BlueRock Therapeutics in Cambridge, MA is seeking a Clinical Safety Physician to oversee medical safety within their clinical portfolio. In this pivotal role, you will act as the medical safety lead, ensuring safety compliance and collaborating with cross-functional teams including Bayer.

The ideal candidate will have an MD and at least 5 years of relevant industry experience, possessing strong regulatory knowledge and communication skills. This position offers a competitive salary and opportunities for influence in a dynamic environment.

Qualifications

• 5+ years in pharmaceutical/biotech industry focusing on drug safety.
• Strong understanding of ICH E2 guidelines.
• Experience with SAE narratives and medical coding (MedDRA).

Responsibilities

• Lead medical safety assessments for clinical trials.
• Oversee safety signal detection and management.
• Collaborate with Bayer's Safety/Pharmacovigilance team.
• Maintain global safety reporting compliance.

Skills

Pharmaceutical/biotech experience in drug safety

Clinical trial safety operations

FDA and EMA safety regulations

Medical writing and communication

Knowledge of signal detection

Education

MD (or equivalent)

Job description

BlueRock Therapeutics in Cambridge, MA is seeking a Clinical Safety Physician to oversee medical safety within their clinical portfolio. In this pivotal role, you will act as the medical safety lead, ensuring safety compliance and collaborating with cross-functional teams including Bayer.

The ideal candidate will have an MD and at least 5 years of relevant industry experience, possessing strong regulatory knowledge and communication skills. This position offers a competitive salary and opportunities for influence in a dynamic environment.