Medical Director, Clinical Development

Olema Oncology; Cambridge (MA); Sur place; USD 250 000 - 320 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Medical leadership

Clinical development

Regulatory knowledge

GCP familiarity

Communication

Cross-functional influence

Formation

MD (US Board Certified)

Description du poste

Role: Medical Director, Clinical Development

focused on advancing Olema's breast cancer therapies, notably palazestrant in Phase 3 trials.

Responsibilities

Provide medical leadership for registration studies, strategic clinical planning, regulatory interactions, and cross-functional collaboration. The role involves designing and overseeing clinical protocols, evaluating safety and efficacy data, supporting regulatory submissions, and contributing to biomarker development and scientific communication.

Qualifications

MD (US Board Certified) with at least 2+ years in biotech or pharma clinical development, preferably in oncology; deep understanding of breast cancer treatment and trial design; knowledge of GCP, FDA, EMA regulations; strong communication, leadership, and cross-functional influence skills.

High-value biopharma specifics: focus on ER+/HER2- metastatic breast cancer, Phase 3 registration-enabling studies, biomarker integration, and collaboration with investigators and regulators.

The role is based in Cambridge, MA, with up to 20% travel expected.