Senior Director, Global Clinical Development Psychiatry and Neurology

Otsuka America Pharmaceutical Inc.; Annapolis (MD); Remote; USD 180,000 - 250,000; Full time

Job summary

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, remote-based or in Rockville, MD or Princeton, NJ. You will design and oversee clinical research programs and protocols for OPDC products under good clinical practices (GCP).

The incumbent will evaluate CNS and Digital Medicine products for a global healthcare market, leading cross-functional teams and strategic regulatory activities.

Qualifications

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist with management experience.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products under GCP.
• Evaluates and develops CNS and Digital Medicine products for a global market.
• Acts as internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and other teams.
• Authors program strategies and study reports; oversees trials essential for determining safety, efficacy and value.
• Interprets and communicates results of Phase I–IV investigations for NDA submissions and regulatory filings.
• Provides strategic oversight of vendor and CRO relationships and governance.
• Leads regulatory filing activities and drafts concise regulatory communications.
• Willingness to travel up to 30% of the time and travel internationally.

Skills

MD/DO physician

Management experience

Clinical medicine knowledge

Communication skills

MS Office

Leadership ability

Drug development knowledge

Education

MD/DO medical degree

PhD/MPH/MBA a plus

Tools

Microsoft Office

Job description

Remote

Full time

R13220

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.”

Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs as well as nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (9.9 billion) in 2016.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

-Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary exists the Global Clinical Development (GCD) department. OPDC-GCD are a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. Our team is collaborative, innovative with a mantra of “acting as though the company was our own.”

Our responsibilities range from due-diligence evaluations, where we stress-test others’ development plans, to development and implementation of our own global development & commercialization plans (GDCP). The GDCP translates basic research and preclinical pharmacology & toxicology into a streamlined plan for first in man, proof of mechanism, registrational and post-approval trials. Its goal is to efficiently evaluate the product’s potential and probability of success, support an effective commercial launch and plan for meaningful innovations to improve or expand the value of the initial product for our global customers (patients, prescribers, and payors).

Detailed Description of Duties:

Otsuka is seeking a Senior Director, Global Clinical Development remote based or in our Rockville, MD or Princeton, NJ offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).

The incumbent will be responsible for the evaluation and clinical development of CNS and Digital Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Senior Director; Global Clinical Development include the following:

Consults with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs, clinical development plans and protocols. - Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and other research project team members, and to external regulatory agencies.

Authors program strategies (i.e., GDCP), protocols, study reports, and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.

Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.

Acts as the signatory on NDA submissions and clinical study and safety documents.

Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.

Provides strategic oversight in our vendor and CRO relationships and provides clinical input into their governance committees.

Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear, and convincing argumentation in all such written and verbal communications.

Detailed Description of Required Qualifications:

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.

• Experience in the pharmaceutical industry or in academic translational clinical research, 6-9 years for Senior Director levels is typically required depending on type of experience at application).

• A thorough knowledge of clinical medicine and science management. This entails defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality.

• An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

• Demonstrated experience leading, managing, and motivating team members (e.g., internal staff and external investigators or consultants). While not essential, prior personnel management experience will support position at entry (Associate Director/Director/Senior Director).

• An advanced understanding of drug development principles and clinical trial implementation, management and reporting is essential and will be further developed, including:

• Flexibility in working across different therapeutic areas and experience in different stages of clinical development.

• Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.

• Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.

• Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies.

• Dedication to assigned, developed projects and project goals. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.

• Willingness to travel 30% of the time, over weekends and ability to travel internationally.

Disclaimer:

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by