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 inalignment 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 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 the interdependency and big picture.

Education & Experience Requirements:

• MD in Neurology with Parkinson 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

Travel Requirements:

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

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

This position includes people-management responsibilities, including day-to-day supervision, workload planning, and ensuring team members have the resources and support needed to succeed.

The base salary range for this role is

$352,200.00 - $440,200.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

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

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.