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.

Scope:

Key role in leading, planning, executing clinical research activities in various indications through all stages of development, including post-marketing commitments.

Key responsibilities:

• Ownership of the key elements in planning 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, and emerging issues.

• Support end-to-end clinical development planning; manage CDP, LRP, internal governance interactions.

• Responsibility for project-related budget.

• Oversee education of investigators, study site personnel, and study staff.

• Responsible for participating in and leading clinical study teams, monitoring overall study integrity, and participate in review, interpretation, and communication of safety and efficacy data.

• Responsible for SAB and DSMB relationships and interactions.

• Present at program-related scientific, medical, and regulatory meetings.

• Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups.

• Contribute to planned regulatory filings including authoring clinical sections for IND, NDA, MAA, PIP, and other related documents.

• Partner with Drug Safety & Pharmacovigilance to monitor the safety profile of compounds.

• Maintain a high level of clinical and scientific awareness 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.

• Co-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 contributions to due diligence or other business development activity.

• Participate in meetings and committees of parent company or other affiliates.

• Establish collaborative and productive relationships with parent company colleagues, internal/external partners, and relevant affiliates.

• Perform other duties as requested.

Professional experience and qualifications:

• 10+ years of pharmaceutical clinical research experience, additional experience in an academic setting advantageous.

• Experience successfully executing global, multi-center, complex clinical research programs with minimal direction.

• Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in implementation 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.

• Experience authoring and reviewing global regulatory submissions required.

• Experience with multiple therapeutic modalities (ex. small molecules, biologics, ATMPs).

• Experience with Phase 4 clinical studies and various study modalities.

• Experience and strength in data management an advantage.

• Experience in Women’s Health preferred; CNS, Rare Disease experience beneficial.

• Excellent communication and presentation skills are essential.

• Advanced degree in life sciences, clinical pharmacology, or related discipline.

• Clinical research certification or regulatory knowledge is beneficial

• Professional English proficiency required, additional languages beneficial.

The base salary range for this role is

$192,320.00 - $240,400.00

Base salary is part of our total rewards package which also inclu