Job Information
Astellas Pharma Clinical Development Scientist, GU Oncology in Markham, Ontario
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.
Making a positive impact on patients’ lives is the purpose behind everything we do. 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.
About Us:
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. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. 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.
Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.
Astellas Pharma Canada (APCA) is looking to fill vacant position – Clinical Development Scientist
Purpose:
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.
Essential Job 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 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.
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).
Early and/or late phase studies
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)
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.
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.
Qualifications Required:
Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 5-7 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.).
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:
Ph.D. or PharmD degree, or other relevant Master’s degree.
Late Stage GU Oncology experience
Knowledge and proficiency related to Medical Affairs activities including registries
Working Environment
This position is remote and is based in Canada.
At Astellas we recognize 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 optimize 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.
Salary Range: $170,000-$220,000 CAD annually per year (final compensation will be determined based on a variety of factors, including but not limited to proficiency levels and organizational equity considerations)
*The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time and national holidays
Registered Retirement Savings Plan Program (RRSP)
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Wellness programs
Astellas may use artificial intelligence-enabled tools at various stages of the recruitment and selection process.
Additional Information
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.
#LI-SS
Category Solid Tumors Medical
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans