Development Scientist

Development Scientist

About Astellas:

At Astellas, experience is coupled energised with a relentless challenger spirit.

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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.

We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.

We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.

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 global Clinical Development Immuno-Oncology division (IOD).

This role Reports to the Medical Lead (IOD) for the given program(s) and is accountable for defining the strategy and execution of assigned trials.

Hybrid Working:

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Responsibilities:

• Work closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Medical Monitor, you will be accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program.
• Be 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.
• Will provide expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
• Will serve 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.
• Under the guidance of study physician/med you will lead, perform medical monitoring activities (Review, analyse and triage patient data, generating reports).
• Will independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.

Essential Knowledge & Experience:

• To perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.
• Able to independently lead 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.
• To partner with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
• Provide training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
• Support engagement with potential and current sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV).

Preferred Experience:

• Extensive experience in solid tumours – lung, colorectal, pancreatic cancers, biologics or immuno-oncology.
• 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.
• 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.
• Experience working in global teams and a global matrixed, remote working environment.

Additional Information:

• This is a permanent, full-time position located in the UK.
• Candidates interested in remote work are encouraged to apply. Remote work is permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our UK office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
• 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.