Associate Medical Director, Clinical Research

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 https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Medical Director, Clinical Development – Oncology. The medical director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key opinion leaders.

Job Duties and Responsibilities

• Lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues.
• Oversee project-related education of investigators, study site personnel, and study staff.
• Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data.
• Present at scientific, medical, and regulatory meetings globally.
• Develop and maintain relationships with academic investigators, pharmaceutical

partners/sponsors, KOL’s, 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 comply with all relevant ethical, regulatory, and legal standards.
• May participate in or lead clinical development contributions to due diligence or other business development activity.
• As required by program needs, contribute in 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. 

Key Core Competencies

• Ability to run a complex clinical research program with minimal direction
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
• Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive
• Able to lead through influence
• Excellent communication and presentation skills are essential.
• Identify the key competencies or attributes required to excel in the role.
• Examples may include problem-solving, teamwork, communication, etc.
• Highlight any specific qualities or traits that are important for success in the role.
• These could include attention to detail, adaptability, creativity, etc.

Education and Experience

• Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD
  • Completion of a residency program strongly preferred<