Director, Clinical Research Scientist

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  or follow us on Linked In.

The Director, Clinical Research Scientist role is an exciting opportunity for a highly motivated individual to be a key contributor to the development and execution of the clinical strategy across the oncology portfolio. This individual will manage a Clinical Development Clinical Research Scientist team to support early and late-stage clinical development to have a strategic and scientific impact on current and future clinical programs.

This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.

• Train Clinical Research Scientists to execute clinical trials in collaboration with clinical operations and medical directors to support study start up, present at SIV, develop deep relationships with Principal Investigators, review eligibility forms, support trials with intensive monitoring support, data review, and data cleaning.
• Lead, recruit and train a team of Clinical Research Scientists with diverse backgrounds and experience to meet the needs of the evolving business.
• Train Clinical Research Scientists to support NDA submissions and all regulatory responses.
• Support corporate goals by working closely with Senior Management.
• Provide strategic support and direction for clinical drug development programs through close interactions in a cross-functional environment by offering scientific and clinical guidance and expertise.
• Provide support for advisory boards, consultant, and investigator meetings, including the preparation and/or delivery of presentations.
• Understand the competitive landscape and provide insights on strategic development pathways.
• Keep abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory requirements.
• Proactively seek out and recommend process improvements.
• Provide development, coaching, and mentorship to direct reports in support of building a high-performing team.
• As necessary, perform medical review of data for safety and efficacy evaluation.
• Collaborate with the project team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting.
• Contribute to drafting manuscripts and other publications and presentations.

• People leadership:
  Demonstrate coaching skills to develop team.
• Cross-Functional Leadership in a matrix environment:
  Build alignment and drive outcomes through collaboration with Clinical Operations, Medical Directors, Biometrics, Clinical Pharmacology, Regulatory, Pharmacovigilance/Safety, Medical Writing, and other stakeholders without relying on direct authority.
• Agility, Resilience, and Change Leadership:
  Remain effective in a fast-paced environment; adapts to priorities quickly, manages ambiguity, and guides the team through an evolving program while maintaining delivery excellence.
• Global and Cross-Cultural Effectiveness:
  Must work effectively across different cultures and regions and maintain diverse and effective teams.
• Scientific Rigor and Clinical Judgment:
  Apply a deep knowledge of oncology and strong clinical reasoning to guide study design, endpoint selection, safety and efficacy evaluation, and interpretation of complex data.
• High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.

• BS/MS/PhD in a related life science discipline or Pharm
  
  D; RN, BSN or MSN preferred.
• Minimum of 10 years of clinical development experience in the pharmaceutical/biotech industry (clinical science, medical writing, etc.)
• Prior oncology drug development experience required.
• Prior experience leading a Clinical Research Scientist team through study design and startup, as well as NDA submission and approval process.
• The candidate will have clinical experience in an oncology clinic, and leading a team through NDA, establish data visualization tools, deliver high touch support of sites in multiple regions.
• Experience in the analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
• Patient profile and data listing review experience.
• Must possess strong analytical, problem-solving, and scientific writing skills.
• Excellent oral and written communication skills and solid PowerPoint, Word, and Excel.
• High level of organizational…