Astellas Pharma Sr. Vice President, Head of Immuno-Oncology Development in Cambridge, Massachusetts
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 .
This position is ideally based on the East Coast, however remote work from certain states may be permitted. Candidates interested in remote work are encouraged to apply and we will also consider qualified candidates outside of the United States.
Purpose and Scope:
To lead the Primary Focus Area Immuno-Oncology Division directly reporting to the Chief Medical Officer. The SVP and Head of Immuno-Oncology is responsible for providing strategic direction and leadership for the development of all compounds across multiple phases across the Oncology and IO primary focus areas. The SVP is responsible for managing the Global Development Project Leads (GDPLs) who lead the cross-functional compound project teams and is also responsible for managing the VP Global Medical Heads with oversight of the Global Medical Leads (GMLs). Ensures that medial expertise and scientific excellence is incorporated into critical plans across all phases of drug development.
Essential Job Responsibilities:
Effectively manages resources to ensure successful development and implementation of development strategies across oncology and immunology programs and facilitating effective, efficient decision making related to protocols, development programs meet timelines, budget, and objectives.
Successful regulatory submissions and subsequent approvals of Investigational New Drug applications, Biologics License Applications, and New Drug Applications.
Oversees training compliance to ensure readiness and competence of staff for future program needs and compliance with Good Clinical Practices and Astellas SOP’s.
Estimated operating budget of 380 Oku Yen and department headcount budget of approximately 30 headcount.
Provides strategic direction and leadership of immunology global primary focus areas development programs from late preclinical to registration and completion of post-approval commitments.
Accountable for ensuring immunology development programs are medically and scientifically rigorous.
Jointly accountable, along with international colleagues across functional areas, for the delivery of projects on time and on budget.
In full alignment and collaboration with the Primary Focus Leads (PFLs), creates the early development pipeline strategy.
Collaborates closely with Drug Development Research (DDR), PFLs and oncology and medical specialties Global Brand Manager (GBM).
Interacts closely with key global development functions including Clinical Science, Regulatory Affairs, Data Science (Statistics, Data Management, and Medical Writing), Pharmacovigilance, Medical Affairs, Business Development, PFLs, Pharmaceutical Technology, Legal, Ethics & Compliance, DDR, Clinical Pharmacology Exploratory Development, Commercial and Finance.
Externally represents Astellas in interactions with regulatory agencies, professional organizations, business partners, and the media per scope of immuno-oncology activities.
An MD, MD/PhD, PhD or PharmD is mandatory with a specialty or equivalent experience in immuno-oncology strongly preferred
Minimum of fifteen years’ experience in drug development with demonstrated experience leading the successful development of complex drug therapies on time, on budget, and with measurable peer review for quality assurance and regulatory compliance
Deep, advanced skill sets in the following areas: business acumen, leadership, written and verbal communication skills, and achieving results through a matrixed, global organization
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
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
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans