The Director, GCD CNS will be responsible for all of the clinical development activities for the CNS projects assigned to him/her and for the successful implementation and completion of trials leading to NDA and/or global filings.
The Director, GCD CNS:
Conceives and analyzes drug development programs, by:
- Understanding the pharmacology of drugs and unmet medical needs;
- Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy;
- Working with experts and consultants in the field to refine a clinical development strategy;
- Designing clinical trials for the purpose of meeting specific objectives;
- Anticipating and addressing future commercial and clinical development needs, based on the clinical character of the compound.
Implements clinical development programs, including:
- Co-authoring global clinical development plans with all practical elements;
- Leading and motivating the clinical development team to operationalize the clinical development strategy, i.e., clinical trials management;
- Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects;
- Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality;
Develops and leads formal presentations of results to the medical community, in written, verbal, and visual formats.
- Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts;
- Partners with biostatistics, medical writers, and external consultants to understand and present the results of clinical development programs.
Partners with internal decision makers to evaluate critical decision points.
Acts as a signatory for the medical monitoring team.Contributes to corporate initiatives by participating in continuous process improvement to meet company objectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
Participates in NDA development, submission and defense.
Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
Requires advanced understanding of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).An advanced understanding of drug development principles and clinical trial implementation and management.Ability to design and run clinical trials and speak to the strategy of the clinical development plan.Complete understanding of the global regulatory requirements.Working knowledge of marketing and commercialization.Complete understanding of overall corporate goals with a fundamental grasp of basic principles needed to work in a business setting.
Skills and Experience
Demonstrated experience in all developmental phases, including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies.Demonstrated experience in successful regulatory filing. Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).Strong data analyses and complex problem solving skills.Strong communication and presentation skills.Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).Knows how/when to apply organizational policy or procedures to a variety of situations.Ability to operate at both strategic and operational levels. This requires:
-A willingness to be hands on, on a regular basis, and personally do whatever it takes to get the job done;
-Ability to be flexible and highly tolerant of ambiguity;
-Being well organized, resourceful, planful, and attentive to detail;
-Ability to persevere and be a game-changer;
Ability to work well with others, in teams. Is open, receptive, and self-aware. Alliance experience desired.Cultural sensitivity (esp. able to work with our Japanese colleagues).Willingness to travel up to 20% of time.
The ideal candidate will have an MD (or equivalent). Board certification in neurology is highly desired, as is a PhD qualification. Minimum of ten years of clinical research experience required, including significant experience in neurodegenerative diseases, such as Alzheimer’s. Prior management experience is ideal.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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 and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also 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.