Lead Development Engineer
3 weeks ago
Clinical Development Scientist Lead, Immuno-Oncology #23-POS00063128M
{{At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.
At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.
We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
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 Asset Lead, and Medical Monitor, 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.
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 GML, Operations Lead, and Medical Monitor/Study Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings.
Under the guidance of study physician/med lead, perform medical monitoring activities (Review, analyze and triage patient data, generating reports
Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
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. Supports engagement with potential and current sites (e.g. 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.
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.
May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.
Performs other duties as assigned or special projects as needed.
This position reports to the Primary Focus Medical Head (or other Leads depending on grade) for designated program.
This position is typically an individual contributor role, but may have direct reports based on scope, accountabilities and complexity of assigned development programs. If position has direct reports, will align with Astellas guidelines for span of control and organizational levels.
Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 9-10 years clinical, scientific/research, pathology or industry related experience or combination of academia and industry.
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.
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.).
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).
Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
Excellent strategic planning, organizational and verbal and written communication skills.
Highest level of scientific integrity.
Able to travel ~25%, with international travel at times
PhD. or PharmD degree, or other relevant Master’s degree.
Knowledge and proficiency related to Medical Affairs activities including registries.
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
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