Astellas Pharma Director, In Vivo Pharmacology in South San Francisco, California
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 .
Xyphos Biosciences , an affiliate of Astellas Pharma Inc. is developing a novel adoptive cell therapy technology platform and building a pipeline of innovative products.
We are a rapidly growing team of research and scientific professionals, passionate about turning science and innovation into medical solutions through our cell therapy technology platform. Through our diversity, scientific knowledge, professional rigor and focus on innovation, we are merging our technology with the Astellas drug development expertise to unlock cures to many therapies. Join our team of committed, enthusiastic professionals devoted to making the most effective, life-saving cell therapy products in the world.
Astellas is announcing a Director, In Vivo Pharmacology opportunity at their Xyphos site in South San Francisco, CA.
The primary purpose of the Director, In Vivo Pharmacology, is for the planning and execution of in vivo studies to characterize the activity and pharmacokinetic/pharmacodynamic (PK/PD) properties of cellular and biologic therapeutic candidates. Working highly independently with significant impact to division objectives and deliverables, this work will involve the management preclinical studies and oversight of contract research organizations (CROs). This position will work primarily in an office setting with R&D teams reporting directly to the Chief Scientific Officer.
Essential Job Responsibilities:
Strategic planning and oversight of the in vivo pharmacology evaluation of cell therapies and various biologic modalities
In vivo study design to enable clear go/no-go decision making for therapeutic programs
Identification of appropriate Contract research organizations for in vivo model execution including negotiating contract details
Externalization of PK and PD assays to support the in vivo investigations of cells and biologic candidates
Stage-specific program team membership as the In vivo pharmacology subject matter expert (SME)
Liaise between various Xyphos/Astellas stakeholders, including disease biologists, PK/PD scientists and non-clinical safety assessment
Ensures the production of high quality technical reports including statistical analyses and data integrity review to support regulatory findings
Present key findings at internal and external meetings
Direct management of Xyphos staff responsible for study management
Be recognized as a people leader on site at Xyphos helping to set and maintain a healthy culture.
- Direct impact on research related to convertibleCARTM platform
Reports to Chief Scientific Officer, Xyphos
Key thought leader within the company on In vivo studies and a people leader who can influence across organizational boundaries
Ability to act as an external ambassador and influencer of external organizations
Ph.D. with a minimum of 14 years' experience in life science or related scientific discipline with extensive experience in design and implementation of multiple animal models of cancer.
Extensive experience in management of CRO-based preclinical studies.
Strong understanding of biologics drug discovery including a history of contributions to regulatory filings, especially in Oncology/Immuno-Oncology.
Strong understanding of understanding PK/PD model design and implementation
Excellent written and verbal communication skills including the ability to influence company stakeholders and senior management
Ability to lead teams as well as be a subject matter expert in a team -- effective collaboration is a critical attribute.
Highly developed problem solving and risk management/critical thinking skills
Excellent work planning, organization, record keeping and attention to detail
A demonstrated ability to manage and mentor direct reports
Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment
Hands-on in vivo experience with a strong understanding of AAALAC guidelines for in vivo work
Proficiency in Cancer Cell therapies including various CAR modalities
Working knowledge of Bioanalytical assay development and implementation
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 Research and Development
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans