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Senior Project Manager, Research and Technical Operations

Employer
Astellas Pharma US, Inc.
Location
South San Francisco, California
Start date
Aug 4, 2022

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Discipline
Manufacturing & Production, Operations, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work
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Job Details

Senior Project Manager, Research & Technical Operations

About Astellas Gene Therapies (AGT)

AGT is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. AGT is a focused, experienced, and passionate team driven to improve the lives of patients.

AGT leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues. Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role

The Senior Project Manager, Research & Technical Operations (RTO) is responsible for providing project management expertise and leadership for products at various stages of development. The Senior PM will be responsible for leading day-to-day activities of research and/or CMC project teams, with the goal of driving cross-functional coordination and support the development of comprehensive plans to ensure the program goals are successfully executed within agreed budgets and timelines. The Senior Project Manager, RTO will work collaboratively with the various functional areas within RTO and other Center of Excellence (COE) stakeholders to ensure smooth and efficient operational implementation of functional/COE goals. This role is a key contributor within RTO at Astellas Gene Therapies. The successful candidate is a confident project manager, with a proven track record in managing and driving project success at the Pre-IND and Post-IND stages in the biotech industry, preferably with gene therapy experience. The position is based in our South San Francisco offices but successful candidate will be allowed hybrid or fully remote based on needs

Responsibilities

  • Serve as PM Lead for multiple complex programs or projects

  • Drives the development and maintenance of cross-functional Research & CMC development plans that align with Core Team and COE objectives

  • Reports program information and supports development of program presentations to the RTO Leadership, heads of functions, and other key stakeholders including business partners in the broader Astellas organization

  • Drives teams to create and evaluate alternatives and identify recommended solutions to program issues

  • Communicates up, down, and across the organization; fosters open communications throughout the organization; is a good listener

  • Understands, communicates and drives teams to meet the deliverables & goals and challenges appropriately

  • Partner with functional areas to develop appropriate resource and prioritization plans and appropriately escalate changes in resource demand, risks, gaps or challenges

  • Provide project management support at external contract research organizations as needed

  • Develops and implements processes needed within RTO

  • Monitors risks in real time to ensure appropriate mitigation plans are put in place

  • Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals

  • Effectively manage multiple projects and responsibilities concurrently

  • Track deliverables from team members and support associated action item management

  • Consistently perform duties within established SOPs, and in accordance with GxP requirements

  • Other duties as assigned.

Required Qualifications

  • BS/BA in related field with 5+ years of relevant biopharmaceutical industry experience, and 2+ years with project management activities for drug development teams

  • Track record of delivering in a fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful and efficient

  • Excellent verbal and written communication and facilitation skills; history of communicating clearly and concisely; bringing issues to closure in cross-functional group settings

  • Outstanding influencing skills up, down and across the organization including executive/senior management

  • Proficient in the use/application of project management tools (i.e. Smartsheet, Timeline Pro or equivalent)

  • Proven ability to work independently, prioritize and manage multiple tasks simultaneously and successfully in a matrix environment

  • Demonstrated experience building and leading complex technical project plan

  • Clear and succinct verbal and written communication skills

  • Strong analytical, problem solving and critical thinking skills

  • Outstanding project management skills

  • Excellent organizational skills, with a demonstrated ability to work in an extremely fast-paced, small company environment with changing priorities while maintaining attention to detail

  • Working knowledge of appropriate relevant regulatory guidance (e.g. ICH, FDA and EMA)

  • Strong written and verbal communication skills, with the ability to clearly articulate complex concepts and strategies

  • Demonstrated leadership and critical thinking skills

  • Project management Certification

  • Previous experience in core Research & CMC functions (e.g. discovery, bioinformatics, translational sciences, analytical development, process development, manufacturing)

  • Experience managing activities at third party contract research organizations (CROs) or contract manufacturing organizations (CMOs)

  • Drug development experience in all phases of development (e.g. IND, BLA)

  • Experience within related functions (e.g. Clinical Operations, Research, Regulatory)

    Preferred Qualifications

  • Prior experience working in multiple phases of drug development (pre-IND to commercialization)

  • Prior background project management at a biotech/pharma company focused on gene therapy or cell therapy

  • Advanced degree

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

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.

#LI-LK

Category RTO Strategy Operations

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Company

Research and Development is at the core of everything we do. It not only drives our work today, but it fosters the work we will do tomorrow, enabling us to develop innovative therapies with the potential to help millions of people. That’s why we’re focused on turning innovative science into value for patients in areas of unmet medical needs where we have expertise and where Astellas believes innovation can help to address some of the most significant of these needs.

To find out more about our Global Research Divisions, please visit our Astellas Research page: Drug Research | Astellas Pharma Inc.

Find Us
Website
Phone
800-695-4321
Location
1 Astellas Way
Northbrook
Illinois
60062
United States
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