Director of Clinical Development - Oncology

Sumitomo Pharma Co., Ltd. is a prominent global pharmaceutical company based in Japan, committed to addressing patient needs across various therapeutic areas including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a strong portfolio of commercialized products and a robust pipeline of investigational assets at various stages, we aim to expedite the discovery and development of innovative therapies for patients. Job Overview We are seeking a passionate and seasoned Director of Clinical Development - Oncology to join our dynamic team. In this pivotal role, you will spearhead the design and execution of clinical studies while cultivating relationships with investigators and key opinion leaders within the oncology field. Key Responsibilities Lead the development and implementation of clinical programs that align with our overall product development strategy, leveraging your strong medical and scientific expertise and knowledge of regulatory compliance and business operations. Oversee educational initiatives for investigators, study site personnel, and team members involved in clinical projects. Guide clinical study teams to ensure study integrity and effectively analyze and communicate safety and efficacy data. Present research findings and updates at global scientific, medical, and regulatory meetings. Build and strengthen relationships with academic investigators, pharmaceutical partners, KOLs, and patient advocacy groups. Contribute to regulatory submissions by authoring clinical sections for INDs, NDAs, and related documents. Work closely with Drug Safety & Pharmacovigilance to evaluate the safety profiles of treatments. Stay current on clinical advancements in oncology through literature reviews, conferences, and engagements with industry experts. Authorship of impactful manuscripts and collaboration with colleagues and thought leaders to achieve publication goals. Maintain the highest ethical standards and ensure compliance with all applicable regulations. Engage in due diligence and other business development initiatives as necessary. Collaborate with Discovery teams to design and execute translational strategies as appropriate. Actively participate in meetings and committees with our parent company and affiliates. Establish and maintain productive relationships with internal and external stakeholders. Work closely with late-stage development teams. Perform additional duties as assigned. Core Competencies Demonstrated ability in managing complex clinical research initiatives independently. Extensive knowledge of clinical trial methodologies, regulatory and compliance processes, along with experience in clinical strategy and protocol design. Exceptional leadership skills and proficiency in maximizing team effectiveness in a cross-functional setting. Strong communication and presentation abilities are critical. Possess excellent analytical and problem-solving skills, with adaptability and attention to detail. Education and Experience Required: Medical Doctor (MD) or Doctor of Osteopathy (DO) or equivalent. Preferred: Completion of a residency program. Desirable: Completion of a subspecialty fellowship. Experience with blood cancers or solid tumors is advantageous. A minimum of 3 years of drug development experience in the pharmaceutical industry is required. The base salary for this position ranges from $236,100 to $295,100. We offer a comprehensive rewards package that includes opportunities for merit-based salary increases, participation in incentive plans, and eligibility for our 401(k) plan along with various insurance coverages. Our generous time-off policy features flexible paid time off, 11 holidays, additional leave during the holiday season, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will reflect individual experience, skills, and other relevant factors. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. All qualified applicants will receive consideration without regard to race, color, religion, national origin, age, gender, sexual orientation, disability, or any other protected characteristic.

Created: 2026-03-04