Director of Medical, Pharmacovigilance and Early Development

Astellas Pharma Inc.; United Kingdom; Hybrid; GBP 100,000 - 140,000; Full time

Job summary

A leading pharmaceutical company seeks a Director of Medical, Pharmacovigilance and Early Development in the UK. The successful candidate will provide clinical safety insights and lead safety strategies for early development. This permanent full-time position offers a hybrid working model, fostering collaboration while supporting innovative health solutions.

Qualifications

• Expertise in clinical safety and pharmacovigilance.
• Experience in designing safety strategies for early-stage studies.
• Leadership in managing cross-functional teams.

Responsibilities

• Support GLP Toxicology studies at Candidate Nomination.
• Develop clinical safety strategies for early-phase protocols.
• Oversee safety surveillance during early development.

Skills

Clinical safety

Pharmacovigilance

Risk management

Data analysis

Leadership

Regulatory requirements understanding

Education

Advanced degree (MD, PhD) in medical or scientific field

Job description

Job Title: Director of Medical, Pharmacovigilance and Early Development, United Kingdom

About Astellas:

At Astellas, we offer an inspiring workplace and a chance to make a positive impact. Our expertise, science, and technology position us as a leading pharma company. We foster an open and progressive culture focused on doing good for others and contributing to a sustainable society. Our goal is to deliver meaningful differences for patients by working locally and drawing on global insights and partnerships.

Our Vision:

Patient Centricity is central to our mission—supporting innovative health solutions through understanding patient experiences. We aim to embed this principle into our daily work, guided by our core values: patient focus, ownership, results, openness, and integrity.

The Role:

As the Director of Medical, Pharmacovigilance, and Early Development (DMPED), reporting to the Team Leader for Early Development Medical Safety, you will provide clinical safety insights to support early development compounds. Your responsibilities include designing GLP Toxicology studies, reviewing non-GLP toxicology and pharmacology data, and evaluating clinical risks and mitigation strategies. During Phase 0, you'll provide predictive safety insights, and during clinical trials, you'll lead safety surveillance until Proof of Concept.

Key Responsibilities:

1. Support GLP Toxicology studies at Candidate Nomination (CN) declaration.
2. Develop clinical safety strategies for the Clinical Development Plan and early-phase protocols.
3. Co-chair the Safety Management Team, analyzing safety data.
4. Create the initial Development Risk Management Plan with the Pharmacovigilance team.
5. Oversee safety surveillance during early development.
6. Communicate safety strategies effectively within the team and train relevant staff.

Required Skills & Experience:

• Expertise in clinical safety, pharmacovigilance, and risk management in early development.
• Knowledge of GLP and clinical study protocols.
• Experience designing safety strategies for early-stage and FIH studies.
• Strong data analysis skills for interim safety data.
• Leadership in managing cross-functional teams.
• Understanding of regulatory requirements related to clinical safety.

Preferred Qualifications:

• Experience co-leading teams in clinical safety and pharmacovigilance.
• Background in drug development from preclinical to early clinical trials.
• Knowledge of global safety standards and reporting.
• Excellent communication and presentation skills.
• Leadership in safety management strategy development.
• Fluency in English.

Qualifications:

• Advanced degree (MD, PhD) or equivalent in a medical or scientific field.

Additional Information:

• Permanent, full-time position based in the UK.
• Hybrid working model: combination of home and at least 1 day/week in the UK office.
• Applicants must be within commuting distance of the office.
• We are an equal opportunity employer, welcoming applicants regardless of race, color, religion, sex, national origin, disability, veteran status, or other protected characteristics.