At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
As a Development Scientist, you will become an integral part of a diverse and agile team, contributing to the development of clinical strategies for assigned modalities or indications within the Global Biopharma and Ophthalmology Development Team division.
You will collaborate closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Medical Monitor, playing a key role in the design, implementation, monitoring, and analysis of clinical studies within the assigned program.
In this role, you will work independently, leveraging your core knowledge of clinical development to enhance your contributions at both the division and portfolio levels.
This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our Central Warsaw office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
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.
Leading and performing medical monitoring activities; reviewing, analysing and triaging patient data and generating reports under the guidance of the study physician.
Working independently to lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
Essential Knowledge & Experience:
Demonstrable core knowledge of Ophthalmology and 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.
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.
Demonstrable experience working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
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.
Knowledge of global pharmacovigilance standards and guidance documents.
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.
This is a permanent full-time position.
This position is based in Central Warsaw, Poland.
This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our Central Warsaw office. Flexibility may be required in line with business need. 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.