VP, Clinical Research, Parkinsons

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Job Overview: This position reports to Chief Development Officer and is part of the Biopharma Clinical Research Team. The role is responsible for providing overall leadership and scientific oversight of clinical development strategies and plans for stem cell therapies, symptomatic treatments, and disease-modifying therapies in the Parkinson’s disease and movement disorders field. Accelerate the US development of DSP-1083, which is building on the success of Amchepry®, a iPS cell-based regenerative therapy developed by Sumitomo Pharma, which has received the world’s first conditional approval in Japan.  The role is responsible for providing overall leadership and scientific oversight of clinical development strategies and plans for Stem Cell Therapies and CNS (Parkinson’s disease and movement disorders) pipeline assets   leading to successful NDA’s, sNDA’s and label optimization from Proof of Concept (PoC) through all phases of clinical development. Essential Functions Required for Job Lead clinical development team to deliver efficient and rigorous clinical development plan in alignment with scientific, ethical company goals in full compliance with global and local regulatory standards and practices Collaborate with key opinion leaders to establish optimal and highly integrated clinical/regulatory development strategies, in full compliance with global and local regulatory standards Maximize design and execution of development plans to achieve an optimal label in all markets Oversee full life cycle of clinical research activities including clinical trial design, and operational planning, execution and project management Ensure that regulatory commitments and all alliance contractual relationships are met and supportive of business development plans Advise R&D and other key stakeholders on the need for additional or new related research relevant to new directions/market trends, and anticipate major changes pertaining to Stem Cell Therapy and CNS clinical pipeline to ensure the maintenance of company leadership in the competitive landscape Develop and maintain excellent peer-to-peer relationships with scientific leadership of key clients, academic institutions and governmental agencies as required Monitor new regulations and maintain regulatory relationships and oversee regulatory compliance policies Collaborate effectively with the leadership team in defining strategic priorities, financial planning activities to support clinical programs and reduce those priorities to executable plans Oversight of the execution of Stem Cell Therapies and CNS clinical programs to assure successful and timely advancement of clinical candidate therapeutics through the clinic and corresponding regulatory submissions, with a special emphasis on an integrated approach to portfolio management and optimization Support publications of pivotal trial data in line with established timelines and ensure study results are reported and in compliance with company standards Conduct reviews of published literature or of clinical and preclinical reports in the field to provide the context for clinical development programs Oversee writing of protocol synopsis and full protocols, and drive the selection of the Scientific/Clinical Advisory Boards and Independent Safety Boards, and play the lead role in their management and oversight Develop, maintain and expand collaborations with outside clinical investigators, key opinion leaders, clinical researchers, and consultants to facilitate and provide guidance for the optimum performance of clinical development programs Provide critical input to CNS related discovery and nonclinical development activities and assist in the establishment of key criteria and selection process of promising clinical candidates within preclinical testing in close partnership with Discovery and other appropriate functional groups. Provide direction and oversight to global and local CNS clinical research teams on all communication to internal and external stakeholders pertaining to the company’s planned or ongoing CNS clinical development plans Perform other duties as directed Knowledge, Skills and Abilities (general & technical): Highly developed understanding of global clinical research dynamics Demonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through continual communication of group mission and team-based outcomes Ability to provide motivational leadership to help the global clinical research organization understand the company's strategy and future Ability to shape, implement and sustain change efforts and instill a culture of accountability and nimbleness Positive reputation with the FDA and other regulatory bodies as well as with peers, investigators, etc. Successful track record of through Ph. II/III stage therapeutic candidates through the clinic to regulatory submission and approvals Extensive knowledge of FDA, Health Canada, European and Asian regulatory markets Must be able to present scientific and integrated clinical/regulatory/business strategy clearly, concisely and credibly to both technical and non-technical audiences Solid understanding of fundamental technology associated with drug candidates and relevant therapeutic areas of expertise specifically in Stem Cell Therapies and CNS, broad spectrum of clinical indica