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.

About the role

This position reports to the Chief Development Officer and is part of the Biopharma Clinical Research Team. The role provides 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. The role will accelerate the US development of DSP-1083, building on the success of Amchepry®, an iPS cell-based regenerative therapy developed by Sumitomo Pharma, which has received the world’s first conditional approval in Japan.

Responsibilities

• Lead the clinical development team to deliver efficient and rigorous clinical development plans in alignment with scientific, ethical, and 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 the full life cycle of clinical research activities including clinical trial design, 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.
• Oversee 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 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.

Requirements

• 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 advancing 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 indications including recent developments in the field, and a strong track record of success.
• High degree of organizational awareness, ability to connect the dots to understand all interdependencies and the big picture.

Qualifications

• MD in Neurology with Parkinson’s disease and/or movement disorders experience required.
• Broad senior leadership experience of 12+ years in the biopharmaceutical industry with primary focus in Stem Cell or Neurology.
• Minimum 12 years of relevant experience in biotech or pharmaceutical industry.

Schedule

Primarily remote role with periodic on-site meetings in the office. Must be able to travel domestically and internationally as needed. 20-30% travel.

Benefits

• Opportunity for merit-based salary increases.
• Short incentive plan participation.
• Eligibility for 401(k) plan.
• Medical, dental, vision, life, and disability insurances.
• Flexible paid time off.
• 11 paid holidays plus additional time off for a shut-down period during the last week of December.
• 80 hours of paid sick time upon hire and each year thereafter.

Pay

The base salary range for this role is $352,200.00 - $440,200.00. Base salary is part of a total rewards package. Total compensation, including base salary, will depend on candidate experience, skills, education, and other factors permitted by law.