Director, Medical, Pharmacovigilance, Early Development

Director, Medical, Pharmacovigilance, Early Development

About Astellas

At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society.

Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.

Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

About this job

As the Director, Medical, Pharmacovigilance, Early Development (DMPED), reporting to the Team Leader for Early Development Medical Safety, this role provides clinical safety insights to support early development compounds. The DMPED joins the Asset Team before Candidate Nomination (CN) and remains until Proof of Concept, after which safety oversight transitions to the Global Safety Officer for later-stage development.

Working closely with the Toxicology expert, the DMPED helps design GLP Toxicology studies, reviews non-GLP toxicology and pharmacology data, and evaluates clinical risk and mitigation strategies. During Phase 0, the DMPED provides predictive clinical safety insights to guide the decision to enter clinical development. Once clinical trials begin, the DMPED leads safety surveillance through to Proof of Concept. As the compound lead within Pharmacovigilance, the DMPED ensures effective communication of safety messages and strategies within the PV team.
At Astellas, we recognize that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

Key Activities for this role

• Provides predictive clinical insights to support GLP Toxicology studies at CN declaration.
• Leads the development of the clinical safety strategy for the Clinical Development Plan, integrated Safety Management Plan, and early-phase clinical study protocols.
• Co-chairs the Safety Management Team (SMT) with the Development Medical Lead, analyzing and presenting interim safety data.
• Oversees the creation of the initial Development Risk Management Plan with the Pharmacovigilance team.
• Accountable for overall safety surveillance during early development, including leading SMT meetings and safety reviews.
• Provides effective communication and training to pharmacovigilance teams to support the robust execution of the safety strategy.

Essential Knowledge & Experience:

• Strong expertise in clinical safety, pharmacovigilance, and risk management in early development.
• In-depth knowledge of Good Laboratory Practices (GLP) and clinical study protocols.
• Proven experience in designing and executing safety strategies for early-stage and First-in-Human (FIH) clinical studies.
• Strong analytical skills to assess interim safety data and guide clinical decision-making.
• Ability to lead cross-functional teams, particularly in managing safety-related aspects of development.
• Familiarity with regulatory requirements and interactions with health authorities regarding clinical safety.

Preferred Qualifications:

• Experience in co-leading cross-functional teams, particularly in clinical safety and pharmacovigilance.Experience with drug development, from preclinical through early-phase clinical trials.
• Familiarity with global regulatory standards and safety reporting requirements.
• Strong communication and presentation skills for internal and external stakeholders.
• Leadership experience in developing and executing safety management strategies.
• Fluent in written and spoken business English.

Educations/Qualifications:

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

Additional information:

• This is a permanent full-time position.
• This position is based in United Kingdom or Poland.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in the United Kingdom or Poland office. Flexibility may be required in line with business need. Candidate must be located within a commutable distance of the office.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.