Senior Director, Global Clinical Development Psychiatry and Neurology

Otsuka Pharmaceutical Co., Ltd.

7d•$249,973 - $388,125•Remote

About The Position

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is seeking a Senior Director, Global Clinical Development to work remotely or from its Rockville, Maryland, or Princeton, New Jersey offices. The role is responsible for designing and overseeing clinical research programs and protocols for OPDC products in accordance with good clinical practices. The incumbent will evaluate and advance central nervous system and digital medicine products at different stages of development for global markets. The Senior Director works with patients and their representatives, clinical, regulatory, and scientific leaders, internal project teams, external regulatory agencies, vendors, and contract research organizations. The role develops clinical program strategies and protocols, oversees trials, interprets and communicates Phase I–IV results, and contributes to regulatory filings. It also includes lifecycle management and strategic planning to assess product safety, efficacy, medical usefulness, and value.

Requirements

M.D. or D.O.; a psychiatrist or neurologist is preferred. Candidates should preferably have direct or indirect management experience.
In exceptional circumstances, candidates with other clinical or scientific doctorates may be considered if complemented by a team or consulting clinician.
Typically 6–9 years of experience in the pharmaceutical industry or academic translational clinical research for Senior Director level, depending on the type of experience.
Thorough knowledge of clinical medicine and science management, including defining clear objectives and delivering business outcomes on time, on budget, and with superior quality.
Effective communication skills in meetings and written and oral presentations.
Facility with Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to lead, manage, and motivate team members, including internal staff and external investigators or consultants.
Advanced understanding of drug development principles and clinical trial implementation, management, and reporting.
Flexibility to work across therapeutic areas and stages of clinical development.
Working knowledge of biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
Complete understanding of global regulatory requirements.
Ability to dedicate effort to assigned projects and goals and work through matrixed teams in a compliant, regulated business setting.
Willingness to travel 30% of the time, including over weekends, and to travel internationally.

Nice To Haves

Supplementary degrees such as a Ph.D., M.P.H., or M.B.A.
Prior personnel management experience.
Experience with successful regulatory filings.
Working knowledge of health value creation, including financial assessment such as net present value, project planning and budgeting, market research, and commercialization strategies.

Responsibilities

Design and oversee clinical research programs and protocols for OPDC products in accordance with good clinical practices.
Evaluate and lead clinical development of CNS and Digital Medicine products at different stages of development for global markets.
Consult patients or their representatives and clinical, regulatory, and scientific leaders, applying their recommendations to optimize trial objectives, designs, development plans, and protocols.
Develop expertise and serve as an internal medical and scientific consultant to health economics, medical affairs, marketing, regulatory, statistics, and other research project teams, as well as external regulatory agencies.
Author global development and commercialization program strategies, protocols, and study reports, and oversee trials that evaluate product candidates’ safety, efficacy, medical usefulness, and value.
Interpret and communicate results from Phase I–IV investigations in preparation for new drug applications.
Act as signatory on NDA submissions and clinical study and safety documents.
Contribute to product lifecycle management from early development, identifying strategic innovations to add value.
Provide strategic oversight of vendor and CRO relationships and clinical input to their governance committees.
Help lead and support regulatory filing activities and documents, providing strategic direction and editing for clear, concise, and convincing communications.