Sumitomo Pharma Co., Ltd

VP, Clinical Research, Parkinsons

US-Remote · Vp

Sponsorship not specified$20k-$30kDetected 5 days ago

ComplianceAccessibilityProject ManagementBusiness DevelopmentRecruitingSignal ProcessingClinical TrialsClinical ResearchFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationCollaboration

About the role

Ensure that regulatory commitments and all alliance contractual relationships are met and supportive of business development plans
Conduct reviews of published literature or of clinical and preclinical reports in the field to provide the context for clinical development programs
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

Responsibilities

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.
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
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
Support publications of pivotal trial data in line with established timelines and ensure study results are reported and in compliance with company standards
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

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
Must be able to travel domestically and internationally as needed.
Must be able to exercise appropriate judgment as necessary.
Excellent written and oral communication skills required.
Requires ability to use a personal computer for extended periods of time.

Skills

Highly developed understanding of global clinical research dynamics
Ability to provide motivational leadership to help the global clinical research organization understand the company's strategy and future
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
High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.

Compensation

The base salary range for this role is
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.

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