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 we further build our Global Clinical development structure, we have a new opportunity for a Senior Director - Lead Clinical Development Scientist for Immuno- Oncology.
The primary focus for this role is the management and input into the development of clinical strategies for assigned modalities or indications within the division (early or late stage).
You will work closely with the Global Medical Lead (GML), Operations Lead, Asset Lead, and Medical Monitor, and be accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within an assigned program. In this role you will be expected to be proactive, experienced, and capable of performing your responsibilities independently to enable increased participation in division and portfolio level initiatives at a senior level.
Hybrid working:
At Astellas we recognise that our employees enjoy having 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:
- For assigned programmes accountable for all activities related to current/planned clinical trials (protocol development, investigator brochures, CRFs, clinical study reports, review of documents, study analyses and reporting. Provide expertise to cross-functional team members to synthesize/contextualize data to facilitate timely decision making.
- Serve on the clinical sub-team supporting preparation of clinical development plans, site identification and management. Lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
- Partner with GML to prepare for Health Authority (HA) meetings and assist in addressing inquiries. May also prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
- Provide training at investigator meetings and site initiation visits and partner with Clinical Ops and Medical Affairs 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. Support engagement with potential/current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
- Serve as key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics
- Provide clinical input into statistical planning, data analysis and interpretation and clinical leadership/support for publication of data (manuscripts/presentations) and disease or technology related scientific publications. Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
Essential Knowledge & Experience:
- Thorough knowledge and demonstrated expertise in the pharmaceutical industry related to clinical drug development (early stage to approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs). Strong computer skills including MS Office and industry-standard software (e.g. EDC systems (RAVE/Inform) and data analysis software (SPSS, R, etc.).
- Fluent in spoken and written English with strong collaboration and communication skills able to interact cross functionally with Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and PV. Demonstrated success collaborating with key external stakeholders (KEEs, investigators, researchers). Knowledge of global pharmacovigilance standards and guidance documents.
- Comfortable working in a flexible, dynamically changing environment, able to exercise sound judgment, and professionalism with the highest level of scientific integrity.
Education/Qualifications:
- Advanced degree in a relevant scientific discipline (PhD, PharmD or MSc preferred) with solid clinical, scientific/research, pathology, or industry-related experience.
Additional information:
- This is a permanent, full time position that can be based in the UK or EU4 major markets
- Candidates should be accessible to a local office should the need arise.
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.