Associate Director Project Manager

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 .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

• Accountable for leading & delivering Project Management activities for assigned products, Core Medical Teams, Core Medical Plans, Product Strategy Teams (Global / Regional) and integrated plans.

• Works in partnership with the relevant TA Head(s) and Core Medical Team Leaders. Provides strategic direction and oversight in ensuring execution and delivery of MA tactics and Launch Excellence activities on time and within budget. Develops new processes and improve existing processes within the organization and governance model.

Essential Job Responsibilities:

Medical Affairs Leadership

• Lead, create, drive and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration with the CMT Lead in the delivery of the CMP and all CMT activities. Same responsibilities for the Global Product Strategy Team working with the GPSTs co-leads (Medical Affairs and Marketing Strategy) and chair. Monitors, tracks and reports timelines, budgets, resource and risks related to all CMT and GPST activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Provides Launch Excellence project management expertise on the tools, planning, processes and execution oversight.

• For assigned products, lead the execution of the annual Core Medical Plan (CMP) and annual budget process for compounds, including quarterly forecasting and proactively manage and communicate budget and budget variance to the PM Forum and senior leadership. Same responsibilities for the Global Product Strategy Team and iGBP working with the GPSTs co-leads (Medical Affairs and Marketing Strategy).

• Collaboration with other medical affairs colleagues in budget planning, forecast review and management in collaboration with M&D finance. Member of team for quarterly budget forecasting for program. Identify tactics at risk and develop plans to mitigate risk of tactics identified. Maintain adherence to scope, budget, timelines and risk mitigation plans. Responsible for vendor contracting for relevant tactics, management, and assess performance and adherence to SOPs.

Matrix Leadership

• Works closely with MA Leadership Team members (MA-LT), Medical Affairs Committee (MA-C), Project Management Forum and other cross functional team members (including, Commercial, and external partners) to ensure full and timely implementation and execution of MA sponsored activities related to CMT, CMP, GPST and integrated plans.

Project Management Technical Expertise

• Leads, develops, and executes strategies focused on Project Management, process improvements, system enhancements, industry benchmarking and organizational learning. Drives continuous improvement. Responsible for upgrading supporting infrastructure, resources, and tools to maximize process efficiencies. Leads Development and maintenance of excellence in strategic planning and project management oversight of all assigned MA activities, as well as project management methodologies, tools, and competencies.

• Delegate for Head of Project Management for assigned initiatives and committees.

• Provide project management support for other MA functional-level projects or initiatives. Assist in the creation of process improvements and help lead organizational change. Share and adopt best practices to improve PM competency

• Leads initiatives to introduce best practices, ensuring adoption and execution of Good Project Management Practices within and across assigned projects

• Provides leadership in identifying and managing risk, including the development of contingency plans

Medical Governance

• Member and/ or Operations Leader of Project Management Offices and member of multiple task forces / committees to develop new processes and improve existing processes within the organization and governance model. Member / co-lead of PM Community, as relevant. Representation in PM Forum meetings or other global project management initiatives. Responsible to provide guidance and training on PM to Project Managers, and to other stakeholder as applicable.

Global / Regional (Geography) Additions

US

• Accountable for leading and collaborating with co-development teams (Pfizer, SeaGen (JMAC, JMWAG, JSC). Project leader for co-development teams (Pfizer, SeaGen (JMAC, JMWAG, JSC) As medical brand plan operational lead, accountable for collaborating with medical brand team leader to drive brand medical team operational excellence & develop and execute medical brand plan. Responsible for driving and implementing effective project management of the brand strategy plan.

• Lead, create, drive and ensure effective project management to all aspects of the US Medical Brand Team (US MBT) functioning and collaborate with global PM members to ensure effective execution. Works in close collaboration with the US Med Brand Lead in the delivery of the CMP and all US MBT activities. Same responsibilities for the US Product Strategy Team working with the PST co-leads (Medical Affairs and Marketing Strategy) and chair. Monitors, tracks and reports timelines, budgets, resource and risks related to all US MBT and US PST activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Leads iGBP development.

• Lead quarterly budget forecasting for program. Identify tactics at risk and develop plans to mitigate risk of tactics identified

• Maintain adherence to scope, budget, timelines and risk mitigation plans

• Responsible for vendor contracting, management, and assess performance and adherence to SOPs.

• Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders

Established Markets

• Pro-actively liaises with tactic owners. Close collaboration with product lead. Serves as a point of address for CMP/CMT/Planning cycle related issues. Provides input for reporting format and process. Takes the lead in coordinating the planning process and format for the rCMT, in close collaboration with the rCMT lead. Pro-actively monitors issue management, analyses root causes and proposes process improvements.

• Lead, create, drive and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Leads the Regional PM Team. Works in close collaboration with the Regional PMs in the delivery of the CMP and all CMT activities. Monitors, tracks and reports timelines, budgets, resource and risks related to all CMT activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution.

• Lead quarterly budget forecasting for program. Identify tactics at risk and develop plans to mitigate risk of tactics identified

• Maintain adherence to scope, budget, timelines and risk mitigation plans

• Responsible for vendor contracting, management, and assess performance and adherence to SOPs.

• Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders.

International Markets and GCN

• Responsible for supporting the Director Clinical Operations & Project Management with leading efforts to develop department expertise to ensure consistent and effective support to the Regional Medical Teams (RMT), Affiliates Medical teams, Regional TA and Regional TA leads, Core Medical Teams (CMT) and Core Medical Plans (CMP) across multiple therapeutic areas. This position will support the department efforts to align with internal stakeholders to ensure best practices are used consistently across functions and regions for project management. This position will also have TA project management responsibilities by managing and tracking the completion of Core Medical Plans (CMPs) and Integrated Brand Plans (IBPs) in order to meet regional project, department and organizational objectives

• Lead, create, drive and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Leads the Regional PM Team. Works in close collaboration with the Regional PMs in the delivery of the CMP and all CMT activities. Monitors, tracks and reports timelines, budgets, resource and risks related to all CMT activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution.

• Lead quarterly budget forecasting for program. Identify tactics at risk and develop plans to mitigate risk of tactics identified

• Maintain adherence to scope, budget, timelines and risk mitigation plans

• Responsible for vendor contracting, management, and assess performance and adherence to SOPs."

• Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders.

• Partners with the regional Clinical Operations groups to support CMP related processes for all study tactics including feasibility assessments as needed.

• Key driver of collaboration efforts within the RMT, building relationships across the Medical Affairs organizations (GMA and the regions) and other functions (HEOR, APGD, Statistics, PV, Regulatory Affairs) to align activities within the CMP

Japan

Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders

Lead, create, drive and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration with the Regional PMs in the delivery of the CMP and all CMT activities. Monitors, tracks and reports timelines, budgets, resource and risks related to all CMT activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Support Affiliates for CMP/CMT/Planning cycle related issues and provides input for reporting format and process. Pro-actively liaises with tactic owners. Close collaboration with product lead. Serves as a point of address for CMP/CMT/Planning cycle related issues. Provides input for reporting format and process. Pro-actively monitors issue management.

Facilitates the logistics of Regional Medical Team (RMT) meetings, CMP review meetings and processes.

Facilitation/Organization of RMT meeting, Updates/coordination to regional MALT meetings

The Associate Director Project Management is the head of the Medical Affairs Japan Project Management team.

Works in partnership with the relevant Japan TA Head(s) and J-CMT Leaders.

Quantitative Dimensions:

• Monitor, tracks, reports annual MA budget for assigned products, ensuring issues are reported efficiently with required level of detail. Member of cross-functional planning, budget and key Medical Affairs operational projects. Acts as department liaison to ensure transparency and implementation of organizational best practices and standards for Medical Affairs. Collaborates with other Medical Affairs members of region to ensure alignment within region or global, as relevant.

• Core Medical Plan (Strategy and Operations) and GPST deliverables development and execution. US MA: US PST deliverables development and execution

• Oversight and execution of assigned Medical Affairs product portfolio, including co-development partners, where relevant.

• Proactively assesses constraints for their assigned programs and departmental projects to mitigate risks.

• Contribute to divisional and corporate initiatives; influences the acceleration of all projects assigned to MA.

Organizational Context:

• May Report to Director or Head Project Management, Medical Affairs in relevant structure e.g. global or region / affiliate.

• Maintains strong working partnerships with Project Management peers and subject matter experts in Global/ Regions / Affiliates, Development, and Commercial. Maintains strong working partnerships with co-development partners.

• Collaborates directly with TA Heads; MA-C member; CMT members; GPST members; regional PSTs; global, regional and affiliate MA; MAPAC; MA-C; E&C; Legal; PM Forum members; Budget & Control; Commercial; Development and key other stakeholders necessary to accomplish corporate and department goals. Collaborates with co-development partners and associated joint committees / joint teams.

• Collaborates closely with external stakeholders: Key External Experts (KEEs) and vendors to lead and execute Advisory Engagements.

• This role often works with a virtual team and may require up to 30% travel.

Qualifications:

Required

• Bachelor’s degree and at least 10 years pharma industry (or related) experience extensive pharma industry (or related) experience, or Master’s degree and at least 7 years pharma industry (or related) experience

• Substantial project management, operations, or business analysis experience

• Previous leadership experience and demonstration of working autonomously

• Proven decision-making skills leading to successful outcomes

• Strong written and oral communication, strong negotiation and influencing skills

• Significant knowledge of global drug development and product lifecycle management processes

• Significant knowledge of key interfacing organizations (finance, development, marketing)

• Experience of leading and driving project management activities

• Ability to work in a matrix environment and function autonomously

• Demonstrated ability to manage multiple projects simultaneously

• Advanced use of word, PowerPoint, and spreadsheet software (PivotTables, etc.)

• Good time management, planning and scheduling skills, strong attention to detail

• Team player, collaborative, relationship oriented, good decision and problem-solving ability

• Fluency in English, both written and verbal

• Strong ability to be proactive in identifying and managing project-related issues

• Strong ability to work effectively and collaboratively across a global organization, both cross-functionally and cross-culturally

• Strong ability to be proactive in identifying and managing project-related issues

Preferred

• PMP certification

• Previous line management experience

Benefits:

Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks

• LI-JB1

Category Operational Excellence

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans