Remote Global Director of Clinical Research

Sumitomo Pharma Co., Ltd. is a global pharmaceutical enterprise based in Japan, dedicated to addressing patient needs across oncology, urology, women's health, rare diseases, cell and gene therapies, and CNS. We pride ourselves on our marketed products and a diverse pipeline of early- to late-stage investigational assets aimed at bringing innovative therapies to patients more swiftly. For more information on us, follow our updates online.

Scope:

In this pivotal role, you will lead and manage clinical research activities across various indications, covering all stages of development, including post-marketing requirements.

Key Responsibilities:

• Oversee the planning and implementation of clinical development programs, ensuring alignment with the broader product development strategies grounded in medical and scientific principles.

• Facilitate end-to-end clinical development planning, managing internal governance and long-range plans.

• Oversee project-related budgeting.

• Educate investigators and study site personnel on study protocols and compliance.

• Lead clinical study teams, ensuring the integrity of studies, and participate in the analysis and dissemination of safety and efficacy data.

• Manage relationships with Scientific Advisory Boards (SAB) and Data Safety Monitoring Boards (DSMB).

• Present findings at relevant scientific, medical, and regulatory meetings.

• Foster relationships with academic investigators, pharmaceutical partners, Key Opinion Leaders (KOLs), and patient advocacy groups.

• Support regulatory submissions by drafting clinical sections for IND, NDA, MAA, PIP, and other pertinent documents.

• Collaborate with Drug Safety & Pharmacovigilance to monitor and assess the safety profile of compounds.

• Maintain a strong awareness of clinical and scientific developments within targeted disease areas by reviewing literature, attending conferences, and engaging with experts.

• Contribute to publication objectives by co-authoring manuscripts and collaborating with cross-functional teams.

• Uphold the highest ethical standards in compliance with all relevant regulations and guidelines.

• Engage in business development activities, including due diligence, as needed.

• Participate in various committees and company meetings.

• Build collaborative relationships within the organization and with external partners.

• Execute other duties as assigned.

Qualifications:

• 10+ years of experience in pharmaceutical clinical research; experience in an academic setting is a plus.

• Proven track record in leading global, multi-center clinical research programs with minimal guidance.

• In-depth understanding of clinical trial methodologies, regulatory, and compliance standards, along with demonstrated strategic implementation of study protocols.

• Strong leadership and collaboration skills to foster a high-performing culture within cross-functional teams.

• Experience with global regulatory submissions is essential.

• Familiarity with various therapeutic modalities, including small molecules, biologics, and ATMPs.

• Knowledge of Phase 4 studies and diverse study modalities is beneficial.

• Strong background in data management is preferred.

• Experience in Women's Health is preferred; knowledge in CNS and Rare Diseases is a plus.

• Exceptional communication and presentation skills are crucial.

• Advanced degree in life sciences, clinical pharmacology, or a related field is required.

• Clinical research certification or regulatory knowledge is advantageous.

• Fluency in English is mandatory; additional languages are a plus.

The base salary range for this position is $192,320.00 - $240,400.00. This salary is part of a competitive benefits package that includes merit-based increases, participation in short incentive plans, eligibility for our 401(k) plan, and comprehensive medical, dental, vision, life, and disability coverage. Our generous time-off policy incorporates flexible paid leave, 11 paid holidays, a shutdown week during the last week of December, and 80 hours of paid sick leave upon hire and annually thereafter.

Total compensation will be determined based on unique candidate elements including experience, education, and other legal factors.

Disclaimer: The above statements describe the general nature and level of work performed by individuals in this position and are not meant to be an exhaustive list of all responsibilities and qualifications.

Confidentiality: Employees are expected to handle all information with the highest level of confidentiality in accordance with applicable law.

Compliance: Commit to maintaining compliance with all regulatory and operational guidelines, ensuring that all activities adhere to industry best practices and ethical standards.

This position primarily allows for remote work with occasional on-site meetings. Travel may be required both domestically and internationally.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer.

Applicants will be considered without regard to race, color, creed, religion, national origin, age, ancestry, marital status, sex, disability, military status, or other protected characteristics under law.