What are the responsibilities and job description for the Director Clinical Development position at Teva Pharmaceuticals?
The opportunity
The Director, Clinical Development is responsible for overseeing the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA / QC) procedures, OSHA guidelines, and other state and local regulations as applicable.
How you’ll spend your day
- Performs all job responsibilities in accordance with standards of Good Clinical Practice
- Delegates study responsibilities as appropriate to trained study staff
- Possesses a working knowledge of GCP / ICH guidelines, Clinic SOPs, QA / QC procedures, and Investigator 1572 Form
- Reviews all protocols prior to acceptance at the site for feasibility
- Reviews Investigator's Brochure prior to performing any study related activities
- Ensures informed consent has been obtained prior to performing any study procedures
- Participates in Sponsor dose escalation meetings and other safety discussions with the Medical Monitor
- Performs all study responsibilities in compliance with the IRB approved protocol
- Reviews screening documentation and approves subjects for admission to study
- Reviews admission documentation and approves subject for randomization
- Interprets ECGs within agreed Sponsor timelines
- Reviews and evaluates all study data and comments to the clinical significance of any out of range results
- Performs physical examinations as part of screening evaluation and active study conduct
- Documents all findings in subject specific source documents
- Provides ongoing assessment of the study subject / patient to identify Adverse Events
- Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events and assigns causality
- Provides medical management of adverse events as appropriate
- Completes all study documentation in accordance with the study specific
Your experience and qualifications
Education :
Experience :
Certification / Licensure : ACLS Certification
Knowledge, Skills, Abilities (Other pertinent qualifications / skills / knowledge necessary to perform the essential functions of the job)
Physical Requirements and Working Conditions : Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 50 pounds.
Work Environment :
Enjoy a more rewarding choice
We 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 and holidays.
Life and Disability Protection : Company paid Life and Disability insurance.
The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and / or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
