Exton, Pennsylvania, United States
Global Drug Development Leader Program Delivery / Strategy & Organization/ Alliance Management Spirited and decisive leader with demonstrated success at devising, driving and executing organizational vision through the implementation of resourcing, clinical and marketing strategies. Unique ability to articulate complex concepts in digestible formats, enabling optimized and expeditious decision making within the executive leadership team. Strong problem solving skills, combined with scientific and general business acumen, enabling successful leadership of multi-disciplinary teams and engagement. Expert ability to develop and foster sustained internal and external relationships, create empowered and motivated teams, lead without direct authority, and serve as mentor and coach to colleagues. Drug Development Breadth and Diversity: Oncology (12 yrs), CV (1 yr), Respiratory (4 yrs), GI (3 yrs), Female Health (1 yr), Immuno Inflammation (1), Preclinical, Phases I-IV, Medical Affairs and Life Cycle Management, including both small and large molecule.
Accountable for the study delivery and quality of clinical studies in the USA, across all development phases through life cycle management and including in house studies and studies executed by our strategic partners. Oversee and actively engages with all stakeholders to ensure efficient clinical operations support, quality & delivery of studies placed in the USA, including oversight and business continuity to deliver to agreed objectives. Drive study delivery, business efficiencies, implementation of new process and quality improvement, facilitate sharing of best practices, learning’s and expertise within the US and regional or global where appropriate.
Specialty Franchise including immuno inflammation, dermatology and oncology. Work in partnership with functional team members to optimize plans in support of a reimbursable file and life cycle strategy. Devised and led global ad boards, established a patient advocacy plan, KOL strategy, ISS strategy and IEP. Ensure medical affairs and commercial alignment by coordinating the scientific platform with strategic imperatives, evidence generation plan, marketing company meetings, budget, advisory boards, medical education training roadmaps, publications and governance preparation.
Facilitate the Global Integrated Evidence Team (IET) for a $.5B brand with remit of determining Votrient portfolio data generation gaps and opportunities, create scenario plans, establish solutions for reimbursement challenges, prepare for governance committees and establish focused teams to execute plans Spent 7 months at Novartis Pharma during oncology acquisition and transition.
Respected reputation for building and leveraging external academic and business partnerships collaborating on scientific strategies and program execution. Expert in facilitating comprehensive business scenario strategies enabling decision making for clinical programs, submission planning, portfolio planning and competitive landscape leapfrog strategies. Built cross functional, high performing and empowered teams, while ensuring open and encouraging environments. Accountable for strategic and operational planning strategies for early phase oncology portfolio. Partnered with Clinical, DMPK, Payer Evidence, commercial and Project Management to plan lines of therapy approaches, mono/combo strategies, global influences and time to launch acceleration strategies. Concise decision making by developing and implementing go/no go strategies for compounds moving from PreClinical to FTIH through Phase 2A.
Established and led teams from Protocol Synopsis through Clinical Study Report, preparing for Health Authority Submissions in respiratory and Oncology (budesonide portfolio and early to mid phase oncology) Created an empowered environment where teams feel motivated enabling high performance. Ensure members have the tools and skills to be successful, and mentor based on individual strengths, business goals, and personal needs. Exceptional collaboration and interface skills working with CROs, AROs, KOLs, subsidiaries, and external academic collaborators including NCI, ECOG, and MRC.
Led first clinical signal search collaboration, consisting of 33 Ph I and II studies, between AstraZeneca and the National Cancer Institute (NCI). Authored and implemented Drug Safety Plan marrying NCI and AZ processes, enabling delivery of first NCI CTEP program for AstraZeneca. Awarded Clinical Innovation Award for plan. Strategy and Operational lead for Global Lung and GlioBlastoma Delivery Teams (DTs), in partnership with NCIC and Mass General. Created Ph III go/no go scenarios for a Lung program in partnership with NCIC, while ensuring strong alliance between all entities. Developed and maintained an Academic Alliance process of standards for other emerging compounds to implement, globally across AstraZeneca Oncology. Trained multiple members of processes.
Respiratory