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Astellas Pharma Executive Director, Global Development Project Leader in San Francisco, California

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is 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 the 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.

Our Values:

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.

Purpose:

  • The Executive Director Global Development Project Leader (GDPL) reports to the Vice President, Portfolio, Program and Operations Strategy, Astellas Gene Therapies. The Executive Director GDPL has significant leadership role in the strategic development and implementation of drug development programs from early development stages (P0) through life cycle management and has the capability to lead a high priority asset with significant complexity or a portfolio of diverse assets. This individual also guides other GDPLs through decision-making, technical and strategic planning for programs either as direct reports or as a resource.

  • Responsible for development and deployment of excellence in Global Development Project Leader (GDPL) expertise within Astellas, and for the successful application of this expertise globally for assigned programs.

Essential Job Responsibilities:

  • Responsible for a significant role in the Astellas Gene Therapies portfolio strategy, may lead disease area strategies; including the alignment across multiple projects. Participates in the development and implementation of gene therapy specific objectives and plans in alignment with Divisional objectives and Corporate MTP planning (both short- and long-term objectives).

  • Leads large or complex projects, which may include alliance partnered development projects.

  • Responsible for leading Associate Director, Director or Sr. Director GDPLs, which may or may not be direct reports.

  • Effectively participates in collaboration with Functional Management and Functional Unit Heads, to ensure 1) gene therapy-specific best-in-class knowledge, application, and molecule strategic context is reflected in Core Team Member expertise; 2) that GDPL resources and deliverables meet and exceed their expectations of context, project team leadership and behavior, quality and timeliness of deliverables; 3) optimal review, strategic synthesis and management of Core Team member input at project review governance; and 4) appropriate training and sharing of specific therapeutic knowledge and innovation.

  • With minimal oversight, performs GDPL responsibilities including:

  • Provides strategic direction and leadership of global development programs from P0 through LCM for assigned projects in accordance with the Gene Therapy Center of Excellence strategy, established timelines/milestones and in accordance with all applicable regulatory standards. Responsibilities may include programs at both early and late stages of development. Provides input and leadership in development of budgets, resource estimations and allocation.

  • Assumes a global perspective in development of global projects and effectively collaborates with Therapeutic Area Heads, Functional Unit Heads and Functional Management to ensure Core Teams are effectively resourced. Establishes good working relationships and collaboration with members of the core teams and respective Functional Management (GRL, GCL, JAPL, GDOL, GCMCL, GPML, GCPL, GML/GCDL, and others).

  • In collaboration with Core Team representatives, provides oversight and direction and is accountable for the translation of project/program level strategies into a comprehensive global development plan. Ensures successful application and incorporation of strategic input from Core Team representatives which ensures Gene Therapy Center of Excellence programs meet the highest level of scientific, clinical and technical excellence that also considers the larger disease market landscape.

  • Participates in the assessment of new chemical entities/licensed products for potential in- licensing and acquisition and due diligence projects, primarily but not exclusively within the relevant therapeutic area.

  • Chairs the global project team and reviews development plans for assigned projects at all milestones.

  • Leads preparation of PMDA/EMEA/FDA milestone meetings, such as Pre-IND, End-of- Phase II, Pre-NDA, Advisory Committees, focusing on the key strategic issues.

  • Provides strategic input pertaining to study objectives, including pre-clinical, CMC, and clinical development plans. Facilitates meaningful interpretation and assessment of trial data, and decision making.

  • Accountable for effective leadership within matrix environment for assigned projects implement and ensures key development milestones for assigned projects are met. Actively manages issues, issue escalation and proactively identifies alternative strategies in participation with Core Team representatives to develop and implement risk mitigation strategies which impact key milestones.

  • Defines creative approaches for enhancing product value for assigned projects by promoting brand recognition and thorough product lifecycle management for assigned projects.

  • Facilitates communication and information sharing across project team(s), other functional areas in Astellas both locally and globally. Excellent understanding of the interdependencies of the various disciplines (CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance, etc) what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.

  • Responsible for maintaining up-to-date knowledge of global drug development regulations, good clinical practice guidelines (i.e., GCP, ICH), and compliance issues (e.g.: PhRMA guidelines). Active participant in communications and responses to questions from the organization and teams regarding these aspects of Drug Development.

  • Aware of internal and external developments (scientific, clinical, commercial, competitive, legal, and regulatory) including relevance and impact for the execution of the job responsibilities. Attending and, as appropriate, presenting at major scientific conferences, reviewing published scientific medical literature, leading meetings and discussions with key experts in the relevant therapeutic area are integral to the effectiveness and success of the Executive Director GDPL. Develops and maintains an up-to-date knowledge base for assigned project(s) including knowledge of preclinical and early development program (as available) in partnership with the PMs and/or GPMLs.

  • Develops and maintains an up-to-date knowledge base for assigned project(s), including analysis of competitive drugs in development and marketed products. Knowledgeable about therapeutic area to ensure Target Product Profile is appropriate from holistic product perspective

  • Participates in the development of GDPL specific global standards, processes, SOPs, training and quality control, to the highest level of compliance with ICH, GCP and Astellas policies.

  • Participates in the development and maintenance of effective collaborations with internal key stakeholders and functions.

  • Ensuring common knowledge platform by therapeutic area and molecule, performance management process for GML role.

  • Ensuring alignment with resources, budget, roles and processes associated with project planning and management.

  • With Clinical Development ensure alignment at level of CDP design and content quality

  • With Commercial and Medical Affairs partners, determines appropriate design of studies to incorporate HEOR, QOL and related measures

  • Supports the Global Therapeutic Area Head in development of the knowledge and experience base within the therapeutic area(s)

Quantitative Dimensions:

The Executive Director GDPL is accountable for an Astellas Gene Therapies program or a portfolio of complex projects. The Executive Director GDPL is accountable and responsible for the successful development and implementation of Astellas Gene Therapies program strategies across assigned programs and facilitating effective, efficient decision making. Delays, inadequacies in scientific, clinical and/or technical rigor can impact development timelines/regulatory review periods/acceptance and create significant delay or additional cost. Proactive identification of risks and development of risk mitigation strategies are essential.

Organizational Context:

The Executive Director GDPL reports to the Vice President, Portfolio, and Operations Strategy and may or may not have direct reports (i.e. GDPL's at Associate Director, Director, Senior Director levels) depending on assigned program complexity, number of indications, etc. The Executive Director GDPL is accountable for effectively managing a multi-disciplinary team Core Team accountable to meet critical development timelines. Members of the Core Team are often Associate Directors to Senior Directors (i.e. GML/GCDL, GRL, GDOL, GPAL, GCL, JAPL, GPML, GRPL and others).

Qualifications:

Required

  • Bachelor's Degree and Minimum of ten (10) to fifteen (15) years' experience in drug

  • development in pharmaceuticals, biopharmaceuticals, or biotechnology. An advanced degree such as an MD, PhD, PharmD, M.S. or MBA is preferable with a specialty in the assigned therapeutic area, or equivalent experience with global development required. Three (3) to four (4) years of rare disease experience is preferred.

  • Demonstrated leadership experience including line/project management. At least 5 years' experience leading cross functional matrix teams, with 5 years direct people management experience preferred.

  • Demonstrated effective leadership of drug development projects across multiple program types and increasing complexity and proven track record of leading the development of at least one development candidate within a matrixed, global organization with adherence to quality, excellence and efficiency.

  • Multidisciplinary program management experience, which includes leadership in more than one IND/IMPD, NDA/MAA, Advisory Committee or other PMDA/EMEA/FDA meetings required.

  • Excellent communication and collaboration with team members and relevant people as well as scientists and external decision-makers worldwide.

  • Proven experience leading high performing, cross functional teams and effective partnership with Functional Line Management to raise and resolve team effectiveness issues.

  • A thorough understanding of how to influence local and global regulatory, scientific and commercial environments and both Divisional and Corporate vision and strategies.

  • Proven ability to assimilate data, recognize key variables and analyze complex situations and demonstrated history of making quality judgments.

  • Broad experience partnering with and understanding of multidisciplinary functions contributing to effective and efficient drug development. Includes: internal stakeholders, partners and vendors.

#LI-LK

Category 2511 Program Management

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

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