Director Clinical Development

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

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:

• A medical degree with current Medical Licensure in the state of Florida is required.  A combination of board eligibility, medical education, training, and experience may be considered in lieu of board certification.

 

Experience:

• Minimum of two (2) years of clinical research experience, Phase I  preferred

 

Certification/Licensure:  ACLS Certification

 

Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)

• Possesses excellent organizational and time-management skills and a strong attention to detail
• Possesses excellent oral, written, and interpersonal communication skills
• Able to work independently and handle multiple competing priorities in a fast paced environment
• Demonstrates familiarity with database design and relational databases
• Knowledge of medical and research terminology and procedures and clinical data
• Trained in computerized systems for clinical trials
• Proficient in Word, Excel, Outlook, and Microsoft Access
• Speaks, reads, and writes English fluently

 

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:

• Predominantly clinical conduct environment
• Supervisory, team leadership

 

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. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.  
 
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. 
 
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Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.