The Clinical Development Director is responsible for the development, execution and management of clinical programs worldwide across all phases of clinical research. The Clinical Development Director will oversee study teams and will be responsible for leading cross-functional teams in a matrix environment. The individual is expected to be able to function independently in the daily management of clinical research projects including the preparation/review of related key documents (i.e. protocols, Investigator’s Brochures, clinical study reports, summaries for regulatory submissions). The Clinical Development Director is responsible for designing and implementation of the clinical development plan and will provide leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, and pre-clinical development in this regard. The Clinical Development Director will be a key contributor to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. The Clinical Development Director will foster relationships with opinion leaders in assigned disease areas.
How you’ll spend your day Will be a core member of the Global Program Team Will have and maintain the expertise necessary for the clinical development of the product Prepares and manages multiple Clinical Development Plans Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion Makes presentations at the Investigator Meetings and other relevant internal or external Venues Responsible for securing the required human resources to implement the Clinical Development Plan Provides clinical leadership and expertise in meetings with Health Authorities globally. Provides input and direction to Protocols, Clinical Study Reports and other relevant clinical documents Able to secure, manage and maintain critical partnerships with key business partners; Ability to interface professionally with a wide spectrum of internal and external academicians, agencies and industry executives in the scientific/medical arena Serves as medical monitor providing medical support and guidance in investigator selection, study design, data collection and study conduct, patient/subject safety and oversees CRO medical monitor. Foster relationships with opinion leaders in assigned disease areas.
This position can be based in West Chester, PA or Parsippany, NJ on-site 3 days a week.
Your experience and qualifications MD is required Board certification in psychiatry and/or strong experience in clinical development in psychiatry A minimum of 3 years pharmaceutical industry experience with experience developing and directing clinical trials Proven track record of leading studies from early stage through to regulatory submissions Must have the ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena Must be able to work on multiple projects with aggressive timelines Must be able to work independently, without daily direction Strong interpersonal and leadership skills Excellent oral and written presentation capabilities Fluent English Enjoy a more rewarding choiceWe offer a competitive benefits package, including:
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays. Life and Disability Protection: Company paid Life and Disability insurance. Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
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