Medical Director, Clinical Development - Oncology

 and development of innovative therapies to benefit patients sooner.

Job Overview

We are looking for a passionate and experienced Medical Director, Clinical Development - Oncology to join our team. In this crucial role, you will lead the design and management of clinical studies while fostering relationships with investigators and key opinion leaders in the field.

Key Responsibilities
• Take charge of the development and implementation of clinical programs aligned with the overall product development strategy, utilizing strong medical and scientific foundations, knowledge of compliance, regulatory standards, and business operations.
• Oversee educational efforts for investigators, study site personnel, and team members involved in clinical projects.
• Lead clinical study teams, ensuring the integrity of studies, while effectively analyzing and communicating safety and efficacy data.
• Present findings and updates at scientific, medical, and regulatory meetings globally.
• Nurture relationships with academic investigators, pharmaceutical partners, KOLs, and patient advocacy groups.
• Contribute to regulatory submissions by authoring clinical sections for INDs, NDAs, and related documentation.
• Collaborate with Drug Safety & Pharmacovigilance to evaluate the safety profiles of treatments.
• Keep abreast of clinical advancements in oncology through literature review, conferences, and engagements with industry experts.
• Author impactful manuscripts and work with colleagues and thought leaders to fulfill publication objectives.
• Uphold the highest ethical standards and ensure compliance with all relevant regulations.
• Participate in due diligence and other business development initiatives as needed.
• Collaborate with Discovery teams on the design and execution of translational strategies when applicable.
• Engage actively in meetings and committees with our parent company and affiliates.
• Build and sustain productive relationships with internal and external stakeholders.
• Coordinate closely with late-stage development teams.
• Perform additional duties as assigned.

Core Competencies
• Proficiency in managing complex clinical research initiatives independently.
• In-depth knowledge of clinical trial methodologies, regulatory and compliance processes, and experience in clinical strategy and protocol design.
• Exemplary leadership abilities and adept in maximizing team potential in a cross-functional environment.
• Strong communication and presentation skills are essential.
• Possess analytical and problem-solving skills, adaptability, and a detail-oriented mindset.

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 a plus.
• Minimum of 3 years of drug development experience in pharmaceuticals is required.

The base salary for this position is $236,100 to $295,100. We offer a comprehensive rewards package that includes opportunities for merit-based salary increases, incentive plan participation, and eligibility for our 401(k) plan along with various insurance coverages. Our generous time-off policy includes flexible paid time off, 11 holidays, additional leave during the holiday season, and 80 hours of paid sick time upon hire and each year following. Total compensation will reflect individual experience, skills, and other relevant factors.

Sumitomo Pharma America (SMPA) is proud to be 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.