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.
Description
Reporting to the Team Leader for Early Development Medical Safety, and as a
member of the Asset Team, the Early Development Global Safety Officer (EDGSO)
has primary accountability for providing clinical safety insight to support
development and execution of clinical safety surveillance planning for compounds
entering development, and for overseeing safety surveillance in the early
development stage. The EDGSO joins the Asset Team just prior to Candidate
Nomination (CN) and remains on this team until declaration of Proof on Concept,
at which time safety oversight activities are fully transitioned to the Global
Safety Officer for late-stage development and post-marketing safety oversight.
Working in close collaboration with the Toxicology expert on the Asset Team, the
EDGSO provides clinical expertise to help inform the development of Good
Laboratory Practices (GLP) Toxicology study design as part of the Astellas
Candidate Nomination Declaration Committee (CND-C) process, assessing data from
non-GLP toxicology and pharmacology studies and considering projected product
target and mechanism of action. During the Phase 0 period, the EDGSO will
provide predictive clinical safety insights to inform the decision to move into
clinical development, with focus on clinical interpretation of non-clinical
risks, clinical risk assessment and potential mitigation strategies. Following
entry into development, the EDGSO serves as the drug safety lead on the Asset
Team, overseeing safety surveillance through the establishment of Proof of
Concept.
As the compound lead within Pharmacovigilance, the EDGSO serves as the primary
liaison for other members of the Pharmacovigilance team, to ensure the
communication of key compound safety messages and execution of safety strategies
within PV.
Essential Job Duties
- Provides predictive clinical insights to support development of the GLP
Toxicology studies at CN declaration.
- Provides clinical perspectives on the developing preclinical GLP study
package requirements to achieve the IND, by translating preclinical
pharmacology and toxicology data into actionable safety strategies in
early-stage/FIH studies.
- Leads the development of the clinical safety strategy to be included in the
Clinical Development Plan, integrated Safety Management Plan and early phase
clinical study protocols
- Co-chairs the Safety Management Team, in conjunction with the Development
Medical Lead; drives the analysis and presentation of interim safety data
from ongoing clinical studies at each SMT
- Working with the Pharmacovigilance Scientist, PV Risk Management and
Pharmaco-Epidemiology, the EDGSO oversees the creation of the initial
Development Risk Management Plan.
- Accountable for the overall safety surveillance of the compound in early
development, including timely and thorough safety review as the lead for the
Safety Management Team (SMT) meetings
- Provides patient safety-related insights and assessments during the early
development period to support periodic, stage-gate Asset assessments as part
of the Quality Framework.
- Provides effective communication and training to Regulatory Affairs and
Pharmacovigilance teams (e.g., Safety Science, Epidemiology, Operations) to
support robust execution of the safety strategy.
- Accountable for providing rapid and effective communication of important
safety issues to RAPV management, with thorough analysis of the issue and
proposed mitigation/ management strategies
- Represents the project team at the enterprise level and for external safety
committees and/or Health Authority interactions for issues relating to
clinical safety
Qualifications
Required Qualifications
- Advanced scientific degree (MD, PHD, PharmD) required, MD preferred
- Minimum of 5 years’ experience in Clinical Drug Development as a development
or drug safety physician, with at least 2 years’ experience in drug safety
(e.g., safety signalling, risk management and mitigation)
- Thorough understanding of and ability to interpret clinical, translational,
and mechanistic data, with focus the clinical safety implications of
preclinical data.
- Excellent medical knowledge and safety surveillance expertise
- Demonstrated ability to recognize, anticipate and communicate issues
proactively
- Understanding of drug safety regulatory requirements for investigational
products, including ICH, 21 CFR, EU GVP and JP regulations
- Track record in the strategic development and implementation of clinical
safety assessment during the early drug development process.
- Ability to drive decision-making and influence stakeholders in a matrix
environment
- Comfortable in a fast-paced, high pressure company environment and able to
adapt to changing priorities.
- Ability to deliver under pressure
- Strong leadership, strategic thinking, interpersonal and communication skills
- Demonstrated Enterprise mindset
- Ability to interact with all audiences and clearly and concisely present
data, strategy and risk assessment.
Preferred Qualifications
- 5 years’ experience in drug safety or pharmacovigilance is preferred
- Early Development experience (i.e., supporting clinical trials up to Proof of
Concept), with bridging of preclinical to clinical phases
- Experience/ Medical knowledge in oncology, immunology, or cell and gene
therapy development preferred
- Work in a global or cross-cultural environment preferred
LI-SS
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.
No telephone inquiries, in-person applications, or agencies please. While we
appreciate all applications, only candidates under consideration will be
contacted.
