Oncology Medical Director, Clinical Development (Remote)

Sumitomo Pharma; Raleigh (NC); Remote; USD 225,000 - 282,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Flexible paid time off

Holidays

Job summary

Sumitomo Pharma America is seeking an Associate Medical Director, Clinical Development – Oncology. The role leads design and execution of complex oncology studies, collaborates with investigators, and supports regulatory filings while maintaining high scientific standards.

The position emphasizes hematologic malignancies, cross-functional leadership, and active scientific leadership across global meetings. Strong communication and collaboration skills are essential for success.

Qualifications

• Medical Doctor (MD), DO, or non-US equivalent of MD
• Completion of a residency program strongly preferred
• Completion of a subspecialty fellowship is desirable
• Experience in blood cancers or solid tumors desirable
• 0 to 3 years of pharmaceutical drug development experience required

Responsibilities

• Demonstrate ownership of the design and implementation of a clinical protocol that supports the product development plan, based on strong medical and scientific principles. An emphasis on hematological malignancies is preferred
• Provide clinical and medical input to protocols, regulatory documents, publications, and site/investigator interactions especially in complex patient cases
• Respond to site questions related to eligibility, concomitant medication assessments, dose modification guidance, and provide investigator medical support
• Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data
• Conduct study support, data review and query of sites, and provide scientific leadership with clinical research scientists
• Present at scientific, medical, and regulatory meetings globally
• Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOLs, and patient advocacy groups
• Contribute to company’s planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents
• Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders
• Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
• Maintain ethical standards of the highest level and have the knowledge and ability to
• undefined
• As required by program needs, contribute to partnership with Discovery colleagues to the design and implementation of translational strategies
• Participate in meetings and committees of parent company or other affiliates.
• Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates.
• Work in close collaboration with the late-stage development group
• Perform other duties as requested.

Skills

Clinical trial leadership

Hematological malignancies knowledge

Regulatory & compliance understanding

Cross-functional collaboration

Communication skills

Education

MD/DO or non-US equivalent

Residency completion

Subspecialty fellowship desirable

Experience in hematologic cancers

0-3 years pharma drug development experience

Job description

Sumitomo Pharma America is seeking an Associate Medical Director, Clinical Development – Oncology. The role leads design and execution of complex oncology studies, collaborates with investigators, and supports regulatory filings while maintaining high scientific standards.

The position emphasizes hematologic malignancies, cross-functional leadership, and active scientific leadership across global meetings. Strong communication and collaboration skills are essential for success.