Medical Director, Clinical Development — Breast Cancer (Phase 3)

Olema Oncology; Cambridge (MA); On-site; USD 250,000 - 320,000; Full time

Job summary

Olema is seeking a Medical Director, Clinical Development to lead registration studies and strategic clinical planning in oncology, with a focus on breast cancer therapies. The role involves regulatory interactions, protocol design, and biomarker integration, working across functions to advance the program.

The ideal candidate holds an MD with board certification and at least two years in biotech/pharma clinical development, with strong leadership and communication skills to influence

Qualifications

• MD (US Board Certified) with 2+ years in biotech/pharma clinical development, oncology preferred.
• Strong understanding of breast cancer treatment and trial design.
• Knowledge of GCP, FDA, EMA regulations.
• Excellent communication and leadership with cross-functional influence.

Responsibilities

• Provide medical leadership for registration studies, strategic clinical planning, regulatory interactions, and cross-functional collaboration.
• Design and oversee clinical protocols, including safety and efficacy data evaluation.
• Support regulatory submissions and interactions with authorities.
• Contribute to biomarker development and scientific communication.

Skills

Medical leadership

Clinical development

Regulatory knowledge

GCP familiarity

Communication

Cross-functional influence

Education

MD (US Board Certified)

Job description

Olema is seeking a Medical Director, Clinical Development to lead registration studies and strategic clinical planning in oncology, with a focus on breast cancer therapies. The role involves regulatory interactions, protocol design, and biomarker integration, working across functions to advance the program.

The ideal candidate holds an MD with board certification and at least two years in biotech/pharma clinical development, with strong leadership and communication skills to influence