Astellas Pharma Director Global Development Project Leader (Medical Specialties) in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Director Global Development Project Leader opportunity in Northbrook, IL.
Position & Scope:
The Director Global Development Project Leader (GDPL) reports to either a VP, an Executive Director or a Senior Director GDPL and is responsible for the execution of the Therapeutic Area Strategy for assigned programs. The Director GDPL plays a project team leadership role responsible for the execution of strategic development and implementation plans. These plans are for drug development or Combination Product programs for (novel) compounds that may be in any phase from early development stages (P0) through global approval across one or more indications. The Director GDPL provides direction and project team leadership for one or multiple Astellas Development Core teams including late stage and complex projects.
Essential Job Responsibilities:
- Provides leadership of global development programs from P0 to NDA/MAA for assigned projects in accordance with the global therapeutic area 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. Requires ability to prioritize deliverables relative to the project plan, ability to resolve conflicts amongst/between team members vs. escalations to management as first action.
- Assumes a global perspective in development of global projects and effectively collaborates with other GDPLs, Therapeutic Area Heads, Functional Unit Heads and Functional Management to ensure Development Core Teams are effectively resourced. Establishes good working relationships and collaboration with members of the core teams and respective Functional Management. (GRL, GDOL, GSTATL, GPML, GCPL, GML, PM-TA and others). Global collaboration also includes key discussions with DDR, Technology, Global Marketing Strategy and Medical Affairs.
- 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 M&D development programs meet the highest level of scientific, clinical and technical excellence.
- Participates in the assessment and due diligence of new chemical entities for potential in- licensing and acquisition, 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.
- 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, 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.
- Maintains an up-to-date knowledge of global drug development regulations, good clinical practice guidelines (i.e., GCP, ICH), and compliance issues (e.g.: PhRMA guidelines).
- Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, and regulatory) relevant for the execution of the job responsibilities. This includes attendance of major scientific conferences, review of published scientific medical literature, frequent meetings and discussions with key experts in the relevant therapeutic area. Develops and maintains an up-to-date knowledge base for assigned project(s) including knowledge of preclinical and early development program (as available).
- 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 specialty to ensure target product profile is appropriate from a scientific perspective.
- Supports the Global Therapeutic Area Head in development of the knowledge and experience base within the therapeutic area(s).
- Participates in the development and maintenance of effective collaborations with internal key stakeholders and functions, as well as the selection and oversight with PRSM of relevant external vendors.
- With TAHs, ensures common knowledge platform by therapeutic area and molecule, performance management process for GDPL role.
- With the Global TAH and with PRSM, DPM and IT ensures alignment with resources, budget, roles and processes associated with project planning and management.
- With Clinical Pharmacology, ensures alignment at level of CDP design and content quality, role of medical monitor for phase I and POC trials.
- With Commercial and Medical Affairs partners determines appropriate design of early and late phase studies to incorporate health outcomes, population modeling, etc.
The Director GDPL is accountable for Astellas Development programs and their annual budget. This includes direct study costs which will vary depending on the size and stage of the clinical program as well as general costs used for program related travel, consultant fees, etc.
The Director GDPL is accountable and responsible for the successful development and implementation of development 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 delays or additional cost. Proactive identification of risks and risk mitigation strategies are essential.
The Director GDPL reports to a Vice President, an Executive Director, or Senior Director GDPL and does not have any direct reports. The Director GDPL is accountable for effectively managing a multi-disciplinary group comprised of Core Team Members to meet critical development timelines. Members of the Core Team are often Associate Directors to Senior Directors (i.e. GML, GRL, GDOL, GSTAL, GMWL, GPML, GCPL and others).
- Bachelor's Degree and Minimum of ten (10) years' experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology. An MD, PhD or PharmD is preferable with a specialty in the assigned therapeutic area, or equivalent experience with global development required.
- Demonstrated effective cross-functional leadership in one or more areas including: line/project management, multidisciplinary program management experience, or leading one or more multi- disciplinary sub-teams within a matrixed, global organization.
- Experience includes leadership in more than one IND/IMPD, NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings.
- Demonstrated effectiveness in communication and partnership with team members and relevant people as well as scientists and external decision-makers worldwide.
- A thorough understanding of how to influence local and global regulatory, scientific and commercial environments.
- Ability to assimilate data, recognize key variables and analyze complex situations.
- Make quality judgments.
- Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
- Understanding of how to educate/advise others on Regulatory Guidance/Internal SOPs/PM concept
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Medical & Development