Associate Medical Director

JR United Kingdom; London; On-site; GBP 80,000 - 120,000; Full time

Job summary

An established industry player is seeking an Associate Medical Director to join their expanding clinical development team. This role involves critical responsibilities such as creating essential trial documents, supporting regulatory submissions, and overseeing scientific and safety data. The ideal candidate will have a strong background in clinical development, particularly within the Rare Disease space, and will play a pivotal role in ensuring compliance and effective communication among key stakeholders. This is a fantastic opportunity to contribute to meaningful drug development and make a significant impact in the pharmaceutical industry.

Qualifications

• 2+ years of experience in the pharmaceutical industry, preferably in Rare Diseases.
• Strong background in clinical development and regulatory support.

Responsibilities

• Develop key trial documents and support regulatory submissions.
• Analyze clinical trial data and ensure data quality.

Skills

Clinical Development

Regulatory Compliance

Data Analysis

Communication

Risk Management

Education

MD or MD PhD

Job description

Job Description: Associate Medical Director

ARTO is currently partnered with a globally renowned mid-sized pharmaceutical company committed to developing drugs within the Rare Disease space.

The company is expanding its clinical development team and is seeking an Associate Medical Director to assist with drug development up to the crucial IND/BLA submission phase.

Key Responsibilities:

1. Document Development & Regulatory Support: Create key trial documents (e.g., IND Annual Reports, Investigator Brochures, Briefing Books) and support regulatory submissions, ensuring compliance with guidelines.
2. Clinical Development & Study Design: Contribute to Clinical Development Plans (CDPs), develop protocols and methodologies, and collaborate on Statistical Analysis Plans (SAPs), while adhering to project timelines.
3. Scientific & Safety Data Oversight: Analyze and interpret clinical trial data, perform safety reviews, ensure data quality, and support safety reporting (e.g., DSURs, SUSARs).
4. Communication & Collaboration: Act as the scientific lead liaising with key stakeholders (e.g., PIs, KOLs, DMCs, Pharmacovigilance, Biometrics), ensuring effective study execution and compliance with GCP.
5. Governance & Risk Mitigation: Represent Clinical Science in study teams, manage study-specific plans, deliver timely results, and proactively identify risks and mitigation strategies for successful trial execution.

Experience Needed:

• MD or MD PhD
• At least 2 years of experience in the pharmaceutical industry
• Rare Disease experience preferred

If this role interests you, please apply through the job advertisement or contact me at [emailprotected].