Senior Director, Lead Clinical Development Scientist, Immuno-Oncology

Senior Director, Lead Clinical Development Scientist, Immuno-Oncology

About Astellas:

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

We pursue innovative science, focussing 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. 

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.