Cambridge, Massachusetts, United States
Project leader with over 20 years of extensive international experience initiating and leading cross-functional teams, programs, regulatory submissions and establishing strategies for product portfolios. Key team member developing and executing strategic and operational programs, crafting business plans, executing changes, and adapting to fast paced environments. Proven track record in strategy/procedural analysis, out-of-the-box thinking, business process efficiency, sustainable and innovative product development. Generating buy-in on all levels while building and mobilizing teams. Broad therapeutic area experience across multiple indications. Key achievements: Pharmaceuticals/ Biologics: • Cross-functional development leadership of a licensed product to strategize/ initiate post-marketing commitments and life cycle management • Building cross-functional strategic and executable plans for Phase 2 studies in motility disorders (Gastroparesis & post-operative GI dysfunction) to move program(s) successfully forward into late-stage development • Successful initiation of geographic expansion into Europe and Emerging Markets for GI motility drug partnership (bridging studies, regulatory submissions) Vaccines: • Adjuvanted, seasonal influenza vaccine (Fluad) in elderly (65+): Developing strategies & clinical programs for the licensure in US & EU; Leading & defending regulatory submissions to FDA; BLA submission achieved (Fluad 65+) in November 2014 - first adjuvanted seasonal vaccine approved in November 2015 (USA) • Pediatric, adjuvanted quadrivalent influenza vaccine: Spearheading strategies for development & implementation of large Phase 3 program (efficacy endpoint, > 10K subjects, budget > $100m) • Licensure of pre-pandemic vaccine Aflunov & H1N1 swine influenza vaccine contributing > 2bn US Dollar in sales/ > 180m doses delivered Cross-functional: • Lead development & roll-out of a “state-of the art” project management tool for the use in Global Program Teams to track key deliverables for research, drug development, manufacturing and marketing.
• Provides global program management and matrixed leadership at an expert level on a high-impact, multi-indication, flagship program with global, cross-functional, and cross-divisional teams, driving development and delivering results under intense organizational scrutiny and expectations. • Demonstrates a strategic vision, and executes on this vision, for establishing a novel organizational structure for program teams of high complexity programs. • Provides inspirational leadership, both within program team and across the TAU. • Leads governance engagements for operational aspects of the program. • Establishes, and executes on strategy for streamlined, timely program communication across a broad and diverse audience. • Direct line management of a team of GPMs supporting the program, including performance management, career development, and mentorship. • Exhibits expert strategic and change management abilities and is seen as change champion for the organization. • Maintains strong team cohesiveness and decision making even through controversial topics. • Influence across R&D organization by proactively sharing insights into how enterprise initiatives are impacting franchise and sharing solutions cross programs.
• Provides leadership and project management skills to global, cross-functional, cross-divisional teams for the successful delivery of early to late-phase complex, (i.e. multi-regions/indications and/or alliance partners) major development or life cycle management activities (including established/marketed products) to meet Takeda’s strategic objectives. • Responsibilities include strategic direction and translating the cross-divisional, integrated GPT product/program strategy into an efficiently executable plan; predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with management and influencing decision-making, monitoring slippage and developing strategies to get back on plan and navigating through the internal governance for projects.
• Appointed to spearhead Submission Project Management Team independently supporting the Regulatory Function and aligning with Senior Management objectives. • Leading and planning for timely delivery of high quality documents for BLAs/sBLA/MAAs/Type II Variations to Health Authorities and related follow-up activities. • Overseeing logistical aspects of building the CTD sections of a submission dossier, communicating status reports within and outside the submission team; anticipating regulatory obstacles and emerging issues throughout the dossier compilation process, and collaboratively developing solutions. • Negotiating and tracking timelines, accountabilities and responsibilities for CTD sections of submission by partnering with Clinical, Technical, Regulatory, PJM and other line functions. • Leading a team of Project Managers; accountable for performance management and talent/career development of direct/indirect reports.
For Job description & details see above (GSK)
• Initiated the design and execution of cross-functional, integrated projects for multiple major vaccines programs. • Provided strategic and critical input to the vaccines programs with regards to content. • Oversaw and enabled sub-teams to develop frameworks addressing development requirements and issues within the program. • Established and implemented processes to ensure cross-functional alignment. • Led and managed feasibility, scenario generation, and contingency planning with functional representatives. • Guided teams to deliver on time, budget, quality, and target assuring cross-functional alignment, pro-actively addressed issues, risk management, and development of contingency plans and alternate solutions. • Created team-building strategies to cultivate high-functioning teams.
• Drove the design and implementation of integrated project plans for global vaccines programs. • Provided strategic and operational leadership to Global Program Team [GPT]. • Acted as deputy GPT Head reporting program progress/issues, preparing selected communication to development leadership such as presentation of strategic issues to senior management. • Instrumental in communicating vision and setting strategic directions for the GPT team to optimize value, time, resources, and mitigating risks while promoting interface with other functions. • Provided critical input to the vaccines portfolio with regard to strategy, content, and managed feasibility considerations with functional representatives. • Demonstrated clear understanding of commercial & financial aspects, provided input into the commercial strategy of the franchise, and challenged assumptions made by line functions.