Astellas Pharma Director / Senior Director, Program Management, Cell Therapy in Seattle, Washington
Director /Senior Director, Program Management, Cell Therapy
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.
Universal Cells , an affiliate of Astellas located in Seattle, WA, is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells to produce cells that avoid rejection and can be used in allogeneic cell therapy treatments to treat all patients that need them.
OUR GOAL - ONE CELL FOR EVERYONE
NO IMMUNE SUPPRESSION. NO DONOR MATCHING. NO REJECTION.
We are a dynamic team of research and scientific professionals who are passionate about turning science and innovation into medical solutions. 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.
Universal Cells (UCI) is announcing a Director /Senior Director, Program Management, Cell Therapy opportunity at their facility in Seattle, WA .
The Director/Sr. Director of Program Management, Cell Therapy, is a critical position responsible for overseeing key research programs and multiple research projects encompassing Astellas Primary Focus Areas, as well as collaborations with external partners. This position plays a key role in strategy development, planning, and implementation plans for research and manufacturing that may be in various phase from early development stages, Candidate Nomination (CN), through global approval across one or more indications. This position works closely with Senior Leaders and Project Leads across Astellas to advance Astellas Cell Therapies to clinical Proof of Concept/Platform by providing both scientific and technical expertise to Global Project Teams, Primary Focus Areas, and cross-divisional development programs.
Essential Job Responsibilities:
Develops research strategy and execution plans with Senior Leaders and supports cell therapy product development activities across affiliates and the greater Astellas. Participates in pertinent Primary Focus area activities related to cell therapy. Provides leadership from Candidate Nomination (CN) to New Drug Applications and Marketing Authorization Applications (NDA/MAA) for assigned projects in accordance with the Astellas primary focus area strategy, established timelines/milestones and in accordance with all applicable regulatory standards.
Provides program management of preclinical development for Universal Donor Cell (UDC)-based product candidates. Facilitates meaningful interpretation and assessment of non-clinical data for decision-making.
Ensures alignment of corporate, sponsored, and affiliate activities to accelerate product development and seek the best way by promoting collaborations and solving internal conflicts if needed.
Provides guidance on engineered cell therapy product development. Authors and reviews Due Diligence evaluations of potential business interests.
Liaison for project planning and transfer of technology, materials, and data with affiliates, sponsored programs, and partners. Engages with Xyphos Cancer Cell Therapy, Center of Excellence and oversees program alignment with Universal Cells, UDC MCB and manufacturing with Astellas Institute for Regenerative Medicine (AIRM), and UDC-dependent AIRM products. Supports some Business Development Alliance Management activities and Universal Cells Project Management for commercial and research collaborations, respectively. Provides inputs in research budgets and resource allocation.
Drives program management excellence and eliminates program inefficiencies, bottlenecks and roadblocks to achieve Astellas Corporate Strategic Plan (CSP).
Identify appropriate stage gates needing decision from senior leaders, facilitates discussions and drives decision making to achieve program goals.
Drives timely communication and messaging to key stakeholders, senior leaders, Astellas Program Leads, program/project managers.
Fosters strong relationships and demonstrates effective and impactful communications to increase awareness, knowledge and develop understanding of programs with Program Leads, program/project managers and key stakeholders across Astellas.
Maintains awareness of Universal Cells research activities to best support programs, authors corporate reports, and provides counsel.
- This position interacts with all levels of management on a routine basis and influences policy and strategy both internally and externally. Works on complex and diverse problems giving guidance and suggestions.
This position is highly strategic and requires high levels of collaboration for success and will require consistent interface with colleagues, affiliates, sponsored programs, and partners
This position will report to the President, Universal Cells.
PhD. degree in biology, or related fields, or equivalent combination of education and experience managing scientific programs/projects.
7-10 years of program/project management experience in a pharmaceutical/biotech industry. Successful experience in oversight of global clinical programs and lifecycle required; experience in BLA/NDA and ex-US equivalent(s), as well as alliance management, strongly preferred.
Demonstrated ability to work independently, proactively and with agility in a complex, matrixed environment, dealing well with ambiguity, building internal alignment, influencing others, and managing differences effectively.
A team player and leader, with strong interpersonal and collaboration skills; able to navigate challenging group dynamics, work effectively across scientific, technical, and divisions in a global organization.
Leadership communication style which facilitates alliances, alignment and collaboration between team members, the program leaders, Research Directors and members of senior management.
Skilled in keeping sight of the bigger picture despite distraction, setting expectations and priorities accordingly.
Must be well-organized with a strategic planning mindset; skilled in program/project management methods and dashboard/reporting tools.
Exceptional critical thinking, judgment, and analytical skills to evaluate the importance and urgency of issues.
Demonstrates interpersonal flexibility and resiliency to effectively lead through complicated programs and/or issues.
Strong technology skills including PowerPoint, SharePoint, Excel, MS Teams, Smartsheet or similar software.
Broad understanding of cell therapy, relevant technologies, and applications.
Formal project management training and/or PMP certification is highly desired.
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