Global Oncology Development Director

Biopharma Careers; Gaithersburg (MD); Hybrid; USD 234,000 - 350,000; Full time

Job summary

AstraZeneca in Gaithersburg, MD or Cambridge, MA is seeking a senior clinical scientist to drive late-phase oncology trials. You will translate strategy into protocols, lead data interpretation, and collaborate with cross-functional teams to support Go/No-Go decisions and regulatory submissions.

You will partner with a physician counterpart and operate in a global, matrixed environment, mentoring staff and guiding study delivery from concept to registration.

Qualifications

• Strong knowledge of FDA and major country regulations.
• Experience with medical monitoring and regulatory submissions.
• Proven ability to lead complex oncology development plans and trials.

Responsibilities

• Translate program strategy into high-quality study documents and related materials.
• Own protocol integrity and secure governance approvals with cross-functional teams.
• Lead trial delivery, recruitment planning, and site/feasibility input across countries.
• Oversee study-level medical monitoring and safety reviews.
• Contribute to regulatory submissions and launch activities.

Skills

Oncology expert

Clinical leadership

Multi-country study design

Regulatory liaison

Education

PharmD / PhD / MD

Job description

AstraZeneca in Gaithersburg, MD or Cambridge, MA is seeking a senior clinical scientist to drive late-phase oncology trials. You will translate strategy into protocols, lead data interpretation, and collaborate with cross-functional teams to support Go/No-Go decisions and regulatory submissions.

You will partner with a physician counterpart and operate in a global, matrixed environment, mentoring staff and guiding study delivery from concept to registration.