Position Summary

The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.

The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.

The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings. 

Key Job Responsibilities

• Conceives, implements, and analyzes drug development programs, including:

• Understanding 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 develop 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.
• Developing and leading 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.
  • Mentors junior team members.

Knowledge, Skills, Competencies, Education, and Experience

Required:

• 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. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia). 
• Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
• An advanced understanding of clinical medicine and science.
• Advanced understanding of drug development principles and clinical trial implementation and management.
• 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 to work in a business setting.
• 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 leading a successful regulatory filing.
• Ability to work across different therapeutic areas and different stages of clinical development.
• Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
• 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.

Physical Demands and Work Environment

Travel (approximately 30%)

See document Physical Demands and Work Environment for further requirements.