Associate Medical Director, Clinical Research

Sumitomo Pharma•Marlborough, MA

2d•Remote

About The Position

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. We are currently seeking a dynamic, highly motivated individual for the position of Associate Medical Director, Clinical Development – Oncology. This individual will develop, plan, execute, and interpret clinical trial activities of novel compounds, in various indications through early development to global regulatory submissions. This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.

Requirements

Medical Doctor (MD), Doctor of Osteopathy (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.
Ability to run a complex clinical research program with some direction.
Extensive knowledge of hematological malignancies is preferred.
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.
Fast-paced environment handling multiple demands is involved.
Must be able to exercise appropriate judgment as necessary.
Requires a high level of initiative and independence.
Excellent written and oral communication skills required.
Requires ability to use a personal computer for extended periods of time.

Nice To Haves

Completion of a residency program strongly preferred.
Completion of a subspecialty fellowship is desirable.
Experience in blood cancers or solid tumors desirable.
Extensive knowledge of hematological malignancies is preferred.

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.