About this role
Oversee critical design and analytical aspects of clinical protocols and statistical analysis plans (SAPs).
Oversee strategy and support operational aspects of clinical trial execution, data management and data analysis in partnership with program operations managers.
Guide content of important clinical and regulatory submissions supporting clinical programs for all stages of development.
Build and maintain relationships with Key Opinion Leaders and recognized thought leaders.
Lead program specific team meetings/presentations with senior management in US, EU and Japan as needed.
Evaluate, interpret, and present complex scientific clinical data as required for senior management on a global basis.
Support regulatory safety reporting for clinical programs: SAE assessment, queries and follow-up, annual reports and investigator brochures.
Draft and review presentations for professional meetings hosted by MDTA on a global basis.
MD or MD/PhD
7+ years clinical development experience, preferably in large pharmaceutical companies, with a strong background in clinical trial design. Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA). Experience in GI is preferred. Experience managing/leading global, cross-functional teams is preferred.High level of expertise working under local and international clinical and regulatory requirements for clinical medicine and drug development processes.
Superior interpersonal skills coupled with multicultural awareness. Able to successfully establish relationships, communicate effectively within/across company disciplines, and thrive within a global, highly matrixed organization. Superb leadership, mentoring and motivational skills; able to marshal teams to achieve goals. Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and commitment to high quality and on-time deliverables. A highly analytical and scientific mind coupled with business acumen; thinks both strategically and tactically. Outstanding writing skills. Willingness to travel up to 50% domestically and internationally.
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee’s Savings Plan (401K Plan) | Competitive Paid Time Off