Director, Project Management, Research & Technical Operations
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.
Be BOLD (Find a Way)
Care Deeply -- for our patients, each other and our work
#GSD (Get Stuff Done)
What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.
The Director, Research & Tech Ops Program Management will serve a key role in establishing and advancing business processes, product lifecycles, and portfolio strategy. The Director, Research & Tech Ops Program Management reports directly to the Head of Research and Technical Operations Strategy, supporting strategic planning and execution of near and long term RTO and corporate goals. The incumbent will play a key role in integrating work across complicated projects with aggressive timelines. This role will require a candidate who is comfortable working collaboratively with technical teams who also enjoys providing hands- on program management support for successful execution of project plans.
Lead, develop and mentor a team of Research and Technical Operations project managers to advance Astellas Gene Therapies' programs, from Entry into Portfolio through commercialization
Manage individual projects and programs as required, based on workloads and priorities
Work closely with the key stakeholders across the Astellas Gene Therapies organization to capture and establish Research and CMC product development strategy, business operations and product lifecycle management
Execute on "right -size" and scalable business processes established for Research and Technical Operations
Partner with the Research Project Team Leads and CMC Team Leads in managing the internal and external team activities. Oversee the successful management of integrated strategic and tactical plans and routinely track performance relative to project plans.
Focus on continuous improvement and operational effectiveness by proactively identifying issues and implement appropriate and timely mitigation plans
Oversee timely preparation of Portfolio and other reports
Prepare presentations to enable alignment and execution of Research and CMC strategy at relevant governance and leadership forums
At least 8 years of experience in biologics drug development environment
At least 5 years of experience in Project Management
Proven track record in leadership and/or business operations, with experience guiding programs to IND and BLA.
Working knowledge of appropriate relevant regulatory guidance (e.g. ICH, FDA and EMA)
Demonstrated ability to influence Research and Technical Operations leadership on complex business topics
Demonstrated understanding of the elements required for successful regulatory submissions and associated interactions
Ability to motivate and coach PMs through research- and CMC-related programs and projects
Excellent communication, time and project management skills and ability to champion strategy
Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
- PMP certification a plus
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Category RTO Strategy Operations
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans