Director of Medical, Pharmacovigilance and Early Development

Director of Medical, Pharmacovigilance and Early Development

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity:

As the Director of Medical, Pharmacovigilance and 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, you will help design GLP Toxicology studies, review non-GLP toxicology and pharmacology data, and evaluate 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, you will lead safety surveillance to Proof of Concept. As the compound lead within Pharmacovigilance, you will ensure effective communication of safety messages and strategies within the PV team.

Hybrid Working:

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 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 Experience:

• 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.

Education/Qualifications:

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

Additional Information:

• This is a permanent, full-time position.
• This position is based in the United Kingdom.
• 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 office. Flexibility may be required in line with business needs. Candidates 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.