Development Scientists

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. The primary purpose of the Development Scientist will participate in 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, and Development Physician, and 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 knowledge of clinical development to enable increased participation in division and portfolio level initiatives. 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. Responsibilities:

• 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.
• Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
• Serves on the clinical sub-team with the GML, Operations Lead, and Medical Monitor/Development Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings.
• Under the guidance of development physician/GML, performs medical monitoring activities (Review, analyze and triage patient data, generating reports
Responsibilities continued:
• Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
• Partners with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
• Together with the GML and Product Responsible Person may prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
• Provides 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.
• Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Exhibits expertise related to Study Data Review and Analysis:
• Provides clinical input into statistical planning, data analysis and interpretation
• Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications
• Works closely with operations group for site and vendor feasibility, trial set up and monitoring.
• May lead the execution of contracts, particularly for investigator meetings and advisories.
• Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
• May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.
• Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
• Performs other duties as assigned or special projects as needed.
  
  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 global regulatory agencies.
• Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
• Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g. electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.).
• 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).
• Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
• Knowledge of global pharmacovigilance standards and guidance documents.
• Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
• Excellent strategic planning, organizational and verbal and written communication skills.
• Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions.
• Aware of cultural diversity and how to influence and manage in a multi-cultural organization.
• Highest level of scientific integrity and impeccable work ethics
Preferred Qualifications / Experience:
• Ph.D. or PharmD degree, or other relevant Master's degree.
• Extensive experience in solid tumours - lung, colorectal, pancreatic cancers, biologics or immuno-oncology.
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.
  
  Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Location and Working Environment This position is hybrid and will require you to be onsite 1 day per quarter at Bourne office in London, UK. The role is offered on a hybrid basis. 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. This role reports to the Global Medical Portfolio Lead, GU and Emerging Areas.,
• The is a permanent full-time position.
• This position is based in the UK. 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.
What awaits you at Astellas?
• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviours:
• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus