Clinical Development Scientist Lead, Immuno-Oncology

Clinical Development Scientist Lead, Immuno-Oncology   #23-POS00063128M

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Job Description

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.

Purpose and Scope:
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.

• 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.
• 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.

Requirements

Required Qualifications:

• 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.).
• 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. Highest level of scientific integrity.
• Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
• Able to travel ~25%, with international travel at times

Preferred Qualifications:

• PhD. or PharmD degree, or other relevant Master’s degree.
• Knowledge and proficiency related to Medical Affairs activities including registries.

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.

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.