Do you want to be part of an inclusive team that works to develop innovative
therapies for patients? Every day, we are driven to develop and deliver
innovative and effective new medicines to patients and physicians. If you want
to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more
than 70 countries around the world. We are committed to turning innovative
science into medical solutions that bring value and hope to patients and their
families. Keeping our focus on addressing unmet medical needs and conducting our
business with ethics and integrity enables us to improve the health of people
throughout the world. For more information on Astellas, please visit our website
at www.astellas.com [http://www.astellas.com].
This position is based in Ontario, Canada. Hybrid work from certain states may
be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Candidates interested in hybrid work are encouraged to apply.
Purpose:
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,
Asset Lead, and Development Physician. The role 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 expertise and experience in
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 on assigned development programs (e.g., develop protocols,
investigator brochures, CRFs, informed consents, and clinical study reports
and review of clinical trial documents, study analyses, and reporting).
- Provides expertise to cross-functional team members to
synthesize/contextualize data to facilitate discussions and timely decision
making.
- Serves on the clinical sub-team with Clinical lead, Operations Lead, and
Medical Monitor/Development Physician; supports preparation of clinical
development plans, site identification and management, and DESC meetings.
- Under the guidance of the development physician/med lead, performs medical
monitoring activities (e.g., review, analyze, and triage patient data,
generate study reports)
- Can independently lead working groups and/or sub-team initiatives in support
of protocol, disease area, or clinical development plans.
- Partners with Clinical lead in preparing for Health Authority (HA) Meetings
and assists in addressing HA inquiries.
- Together with the clinical lead and Product Responsible Person, prepares
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 on enabling appropriate enrollment into clinical studies or
registries. Collaborates cross-functionally to create, review, and/or present
clinical content at internal or external meetings.
- Supports engagement with current and future clinical study sites (e.g., SIVs,
investigator meetings, conferences, steering committee, advisory board
meetings).
- Shows relevant 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 groups for site and vendor feasibility, trial
set up, and data monitoring.
- Leads the execution of contracts, particularly for investigator meetings and
advisories.
- Supports efforts to develop strategic partnerships with Key External Experts
(KEEs)
- Serves as key partner for the Development Division in assessment of
candidates within discovery, identifying opportunities and potential risks in
the context of future development strategies based on modality, indication,
unmet need, competitive landscape, and clinical characteristics.
- May represent clinical development and assist with clinical assessment 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 required.
This position is typically an individual contributor role, but may have direct
reports based on experience, scope, accountabilities and complexity of assigned
development programs. If the position has direct reports, will align with
Astellas guidelines for span of control and organizational levels.
This position reports to the IO Development Medical Lead/Head of disease area
strategy.
Qualifications
Qualifications Required:
- Advanced degree in a relevant scientific discipline; health science or
clinical discipline with typically 7-8 years clinical, scientific/research,
pathology, or industry experience; combination of academia and industry is
acceptable.
- Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical
industry related to clinical drug development (early-stage development
through approval) from initial study design, study start-up & execution to
regulatory submissions (INDs, BLAs, NDAs) within U.S. and ex-U.S.
- 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 (e.g., 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 and impeccable work ethics.
- 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 as required.
Preferred:
- MD, PharmD, or other relevant master’s degree.
- Knowledge and proficiency related to Immuno-Oncology clinical research
Benefits:
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus
national holidays including year-end shut down
- RRSP match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Referral bonus program
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