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
Disclaimer: The above statements are intended to describe the general n
Benefits
Health insuranceDental insuranceVision insurance401(k)Flexible schedule
Additional Information
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.
Sumitomopharma · Remote