Planet Pharma Cambridge , MA 02138
OBJECTIVE: This position is responsible for helping to further the strategic advancement of GPSE in support of GPSEs mission to ensure patient safety. Primary responsibilities include but are not limited to:
Leading key initiatives that have cross-functional impact and that are critical to GPSEs business objectives and/or Takedas global business objectives. This includes integration activities related to acquisitions, mergers and divestments.
Provides expert project/program management and leadership skills to ensure internal, cross-functional, cross-divisional project plans are in place for GPSE related initiatives. This includes providing strategic direction and translating the cross-divisional, integrated GPSE strategy into an executable plan using innovative approaches to ensure rapid and effective decision making
Work directly with the GPSE Head, Chief of Staff (COS), GPSE Leadership Team, and outside departments to support the strategic direction of GPSE by leading high-impact, high-priority projects and overseeing department-wide initiatives.
Support functional resourcing oversight using financial forecasting and headcount management techniques to drive operational excellence.
Enable GPSE to be a successful partner in due diligence activities by creating a Due Diligence Center of Excellence; author and maintain due diligence SOPs, tools, templates, and other related resources.
Liaise with other GPSE functions and Business Development to support due diligence reviews of target companies Pharmacovigilance System, infrastructure, and organization.
Lead or support integration projects for M&As, which may include representing GPSE on cross-functional integration teams. Directly manage and/or liaise with appropriate SMEs on all aspects of the GPSE integration, including project plans & timelines, budget, personnel transitions, safety systems migrations, etc.
Proactively identify and drive project and resource priorities that align with global business objectives. Work closely with stakeholders to balance operational execution with GPSE strategy
Support transformational project/initiatives and change-management activities.
Identify and execute opportunities for infrastructure enhancements and efficiencies, including process improvement.
Develop and implement tools and templates to enable consistency and transparency across GPSE projects.
Liaise with Takedas Vaccine Business Unit to prepare for GPSE support of postmarketing vaccine activities.
Manage and track GPSE budget and FTE resources along with GPSE Chief of Staff, including yearly mid-range planning efforts with Global Finance, comprehensive FTE capacity planning, monthly headcount reconciliation, and GPSE travel oversight.
Support GPSE outsourcing initiatives and vendor engagement, including strategic future-state planning. Work with stakeholders to identify and support implementation of opportunities for efficiency gains.
Contribute to GPSE goal and KPI development, initiative tracking and prioritization, and team engagement activities.
Represent pharmacovigilance department in cross-functional teams and/or meetings at a regional and global level as required, alongside the commensurate communication skills required.
Utilize project and program management expertise to drive project teams to achieve clarity on issues and focus on effective contingencies; interface with management and influence decision-making, monitor progress, gaps, risk management to ensure progress and business continuity
SCOPE OF SUPERVISION: NUMBER SUPERVISED WORKERS Direct In-Direct Employees 0-2 0 Non-Employees 0-2 0
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be highlighted.)
Bachelors required. Post-graduate degree or equivalent (Masters Degree/MBA) preferred
Experience in Alliance Management - both with external business partners/vendors, and with internal key stakeholders and colleagues. Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally
Experience in program and/or project management, preferably in the Pharmaceutical or Biotech industry in clinical development, regulatory affairs, pharmacovigilance, or related function.
Strong ability to proactively identify areas for process improvement and lead infrastructure-related projects efficiently and within given time constraints
An understanding of and experience in the drug development process, including post-marketing and life-cycle management, with a focus on drug safety/pharmacovigilance
Experience in and knowledge of due diligence for company acquisitions and/or licensing partnerships
Demonstrated ability and experience leading high performing teams internally and cross functionally in a global highly matrixed and collaborative environment
Ability to proactively identify and anticipate project risks, including those associated with non-adherence to the regulations, and a keen understanding of when to escalate issues quickly and efficiently
Strong understanding and knowledge of the business areas both internally within the organization and touch points externally
Excellent time management skills
Self starter and strategic thinker
Able to lead teleconferences and meetings
Ability to drive change and manage complex situations, particually with multinational matrix teams
Proven ability to create and implement operational efficiencies
Excellent oral and written communication skills
Strong relationship management skills
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).