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Manager/Director, Clinical Research

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Taro in USA
 
JOB TITLE: Manager/Director, Clinical Research
DEPARTMENT: Clinical
REPORTS TO: Senior Director, Clinical
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GENERAL SUMMARY:
The Manager/Director, Clinical Research is responsible for leading the set-up, implementation, conduct, analysis and reporting of clinical trials for US and Global (Canada, EMEA & Innovative) projects. Responsible for the designing, planning and outsourcing of phase I-IV studies in support of Taro's applications to Global regulatory agencies. Ensures that studies sponsored by Taro are conducted and data is generated, documented and reported in compliance with the study protocol, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), the Declaration of Helsinki and the applicable regulatory requirements in the country where the study is to be conducted. Provides administrative and logistical support, as required. Follows up on current guidance and regulatory requirements related to conduct of clinical studies.
 
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Lead and coordinate clinical development activities for outsourced clinical studies in support of Taro's applications to regulatory agencies
2. Contribute in development and review of clinical protocols, review of scientific literature, work with external consultants to develop clinical study design.
3. Ensure that the studies are completed according to investigational plan and GCP/ICH guidelines
4. Manage CRO’s and other vendors; select CROs, and maintain budgets and timelines; supervise CRO's activities for the set-up, implementation, conduct, analysis and reporting of Taro's clinical studies
5. Review and analyze clinical trial data, prepare scientific conclusion for study results
6. Communicate clinical information and coordinate timelines with multiple internal departments.
7. Prepare clinical documents for ANDA/NDA submissions
 
OTHER DUTIES AND RESPONSIBILITIES:
1. Participate in the development or implementation of clinical trial documents.
2. Support regulatory department in response to FDA deficiency letters
3. Maintain current knowledge of relevant regulations, including proposed and final rules.
4. Provide clinical and FDA/ICH support within and outside of Taro including R&D, Regulatory Affairs, Pharmacovigilance, Marketing and Sales.
 
KNOWLEDGE, SKILLS/ABILITIES & EXPERIENCE TO DO THE JOB:
1. B.Sc. in pharmacy or life science or higher degree and at least 7 years of clinical research experience.
2. Good understanding of the drug development process, GMP/GLP/GCP & ICH/FDA regulations and guidelines
3. Extensive experience in conducting studies for Regulatory Agencies
4. Extensive knowledge of applicable regulations, ICH guidelines and GCP directives.
5. 7+ years of experience in pharmaceutical industry with at least five years of extensive experience in biopharmaceutical aspect of drug product development.
6. Good researching skills and expertise in searching medical literature and databases for clinical and technical information
7. Strong computer skills, e.g. Microsoft Office Programs
8. Ability to multi-task and manage several projects in parallel, paying attention to detail.
9. Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion
10. Good project planning, negotiation and presentation skills.
11. Strong project management skills
12. Excellent interpersonal and verbal/written communication skills.
13. Ability to forge cross-functional working relationships with internal teams and external partners.
14. Ability to resolve routine issues effectively and independently
15. Strong Partnering and collaboration skills
 
WORKING CONDITIONS
1. Full time in-house position.
2. Travel 5% to 30% of time.
3. Work with confidential and sensitive information.
4. Work with international teams on different time zones.
5. Work under pressure of meeting time critical deadlines.
 
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude Taro Pharmaceuticals from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
Taro Pharmaceuticals U.S.A., Inc. provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
 
 
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