Astellas Pharma Biomarker Director (Immuno-Oncology) in Northbrook, Illinois
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.
Purpose & Scope:
Provides science and strategic expertise in biomarker global drug development to project teams across therapeutic areas in alignment with global therapeutic strategy. Responsible for biomarker leadership in support of Global Project Teams; collaborates with other project team members and study team(s) to ensure delivery and quality of biomarker assessment in clinical trials (P1 through P4). Primary focus towards development of personalized medicine and corresponding companion diagnostics. Accountable and responsible for development and implementation of global biomarker development (focus on immuno-oncology). Responsible for designing and conducting global biomarker programs to support regulatory submissions. Supports other projects as required.
Essential Job Responsibilities:
Key responsibility and oversight to study design and project strategy for biomarkers (mechanistic, and predictive/prognostic).
Works with Clinical Development for implementation of biomarker sample collection and bioanalysis.
Collaborates with Core and Extended Teams (Drug Discovery Research and Global Clinical Pharmacology).
Develops and implements use of databases and interprets biomarker data in conjunction with clinical outcomes.
Supports global regulatory strategy and represents biomarker strategy with regulatory agencies.
Implements personalized medicine with primary goal of developing companion diagnostics.
Contributes to clinical documents: protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
Presents to senior leaders and external audiences on clinical aspects of biomarker development including milestones, strategies, and recent data.
Collaborates with Global Clinical Pharmacology Leads across Oncology.
Provides key specifics on companion diagnostic or biomarker sections of regulatory filings.
Responsible for decisions and advice in scientific, clinical and/or technical areas that impact development timelines/regulatory review periods/acceptance and create significant delay or additional costs.
Reports to Senior Director, Global Clinical Pharmacology and Exploratory Development.
Matrixed relationship to colleagues on the Global Project Team, Clinical Operations,
Statistics, Regulatory Affairs, Medical, Clinical Pharmacology and Drug Development Research.
Collaborates with the Astellas Pharma Global Development Project Leaders in assuring the smooth function of the Global Project Team.
Advanced science degree (PhD, PharmD, or MD) with primary focus in biomarker evaluation and CDx development in oncology.
At least 10 years relevant experience in drug development at a biotech/pharmaceutical company or the equivalent experience at an academic clinical research (NCI, NIH, Academic Research groups etc).
Experience providing global oncology biomarker drug development strategy leadership.
Significant and demonstrable working knowledge of regulatory procedures and guidelines in all regions (global scope).
Proven track record in clinical study design, monitoring and execution and results analysis from biomarker perspective.
Strong communication skills (oral, written, and presentations) and cross functional team work are essential.
Demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data.
Proven record of leading teams and obtaining results in a matrix environment.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) 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
Category Clinical Pharmacology and Exploratory Development (CPED)
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans