Director Clinical Pharmacology, Oncology (Biologics)

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 ~~~ .

This position is based in Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The primary purpose of Global Clinical Pharmacology Lead is to be responsible and accountable for clinical pharmacology from first-in human through approval, including post-marketing activities for assigned projects. Therapeutic optimization and individualization (right dose for right patient) by applying state-of-the-art scientific principles and quantitative framework (e.g. MIDD) to evaluate exposure-response relationships based on knowledge of drug disposition, pharmacology, disease biology, patient population, competitive landscape, background therapy, patient variability in PK and responses, formulation effects, impact of immunogenicity.

Essential Job Responsibilities:

• Representing the department and providing subject matter expertise on cross-functional project teams starting with candidate nomination (pre-initiation of GLP tox) through approval and post marketing

• Leading cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals

• Providing effective oversight of clinical pharmacology aspects of clinical trials (including study design, interpretation and communication of results)

• Participating in cross-functional discussions and collaborating with individuals across disciplines; mentoring junior members

• Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions

• Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, diversity and pediatric plans

• Presentation of clinical pharmacology aspects of the global clinical development program at internal and external meetings. For example: meetings with health authorities, congresses, investigator meetings

Qualifications:

Required

• PhD or PharmD with fellowship in clinical pharmacology

• At least 7 years post-graduate experience, in pharmaceutical industry.

• Thorough knowledge of current and emerging scientific standards and global regulatory requirements including familiarity with relevant guidance

• Working knowledge of assigned therapeutic area, biomarkers, bioanalytical methods, immunogenicity

• Have thorough understanding of early development, clinical methodologies, POC, and clinical endpoints within a specific therapeutic area

• Knowledge of biologics drug development

• Excellent written and oral communication skills and ability to convey complex technical information clearly

• Expert knowledge of clinical pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting (including first in human dose setting) and pharmacokinetic/pharmacodynamic relationships

• Experience integrating modeling and simulation activities (i.e., population PK, exposure-response and physiologically based PK) to support the clinical pharmacology plan

• Adaptability and curiosity to learn about new modalities and apply core clinical pharmacology principles to novel therapeutics

• Curiosity and drive to ask questions, learn and keep abreast of literature

• Confidence and ability to present to and influence senior leaders

• Ability to critically analyze problems and provide creative/innovative solutions

• Ability and confidence to work independently

Preferred

• Experience in biologics or novel modalities in all phases of oncology drug development.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 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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Category Clinical Pharmacology (Oncology and IO)

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans