Senior Director, Clinical Development

• 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