Director, Clinical Research

About the Role

The role is part of a global organization with a strong presence in the pharmaceutical industry. Sumitomo Pharma America is committed to addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. As a director, you will be part of a team that is dedicated to bringing novel therapies to patients sooner.

The company is looking for a candidate who is passionate about clinical research, has a strong work ethic, and is able to work collaboratively in a team environment. If you are a motivated and experienced clinical research professional looking for a new challenge, this could be the ideal role for you.

What You Will Do

• Develop and implement clinical development plans for assigned products or indications
• Manage and oversee the execution of clinical trials, including study startup, conduct, and closeout
• Collaborate with cross-functional teams, including medical affairs, regulatory affairs, and commercial operations
• Ensure compliance with regulatory requirements, including GCP, ICH, and FDA regulations
• Develop and manage budgets for clinical trials and programs
• Communicate study results and findings to internal stakeholders, including senior management and external partners
• Participate in the development of regulatory submissions, including IND, NDA, and MAA
• Collaborate with external partners, including CROs, academic institutions, and patient advocacy groups
• Develop and maintain relationships with key opinion leaders and investigators
• Stay up-to-date with industry trends, regulatory requirements, and competitive landscape

What We Are Looking For

• Advanced degree in life sciences, clinical pharmacology, or related discipline
• 10+ years of experience in pharmaceutical clinical research, with at least 5 years of experience in a leadership role
• Strong knowledge of clinical trial methodology, regulatory requirements, and GCP
• Excellent communication and presentation skills
• Ability to work collaboratively in a team environment
• Strong leadership and management skills, with experience in managing cross-functional teams
• Experience with multiple therapeutic modalities, including small molecules, biologics, and ATMPs
• Experience with Phase 4 clinical studies and various study modalities

Nice to Have

• Experience in women's health, CNS, or rare diseases
• Knowledge of data management and statistical analysis
• Experience with global regulatory submissions and FDA interactions
• Certification in clinical research, such as CCRA or CCRP

Benefits and Perks

• Competitive salary and bonus structure
• Comprehensive benefits package, including medical, dental, and vision insurance
• 401(k) retirement plan with company match
• Paid time off and holidays
• Remote work stipend and flexible work arrangements
• Opportunities for professional development and career advancement
• Collaborative and dynamic work environment

• Be prepared to discuss your experience in clinical research, including study design, protocol development, and regulatory submissions.
• Highlight your leadership and management skills, including experience in managing cross-functional teams and collaborating with external partners.
• Show a strong understanding of regulatory requirements, including GCP, ICH, and FDA regulations.
• Emphasize your ability to work collaboratively in a team environment and communicate effectively with internal stakeholders and external partners.
• Consider obtaining certification in clinical research, such as CCRA or CCRP, to demonstrate your expertise and commitment to the field.
• Be prepared to discuss your experience with multiple therapeutic modalities, including small molecules, biologics, and ATMPs.
• Research the company's focus on oncology, urology, and women's health, and be prepared to discuss your experience in these areas.