Development Scientist, Director

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 Development Scientist, you will join a diverse and agile team and contribute to the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Development Physician. The role is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core expertise and experience in clinical development to enable increased participation in division and portfolio level initiatives. This role reports to the Lead Development Scientist and is accountable for defining the strategy and execution of assigned trials. This position can be based in the UK or US.

Hybrid Working: At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Key Responsibilities:

• Being responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs.
• Providing expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
• Serving on the clinical sub-team with GML, Operations Lead, and Medical Monitor/Study Physician and support the preparation of clinical development plans, site identification and management, and DESC meetings.
• Lead, performing medical monitoring activities (reviewing, analysing and triaging patient data, generating reports) - under the guidance of a study physician.
• Leading working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.

Essential Knowledge & Experience:

• Proven experience and core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.
• Independently led working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
• Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
• Trained at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrolment into the clinical studies or registries.
• Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
• Supported engagement with potential and current sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings).

Preferred Knowledge & Experience:

• Extensive experience in solid tumors – lung, colorectal, pancreatic cancers, biologics or immuno-oncology and haematology is desirable.
• Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
• Prior clinical research experience in an academic setting.
• Demonstrable experience working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
• Experience working in global teams and a global matrixed, remote working environment.
• Knowledge of global pharmacovigilance standards and guidance documents.

Education: Advanced degree in a relevant scientific discipline; health science or clinical discipline with extensive clinical, scientific/research, pathology or industry related experience or combination of academia and industry.

Additional Information: This is a permanent, full-time position. This position can be based in the UK or US. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Be able to travel ~25%, with international travel at times. 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.