Senior Director, Clinical Development

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

In your new role as Clinical Project Leader physician (CPL) you will report to the VP Clinical Development Respiratory/Immunology TA, Respiratory TA - US. You will provide clinical leadership and medical monitoring of clinical studies. The CPL is responsible for supporting assigned drug development projects including the Planning and implementation of global clinical research and development programs across all phases of research. The CPL serves as a clinical and professional resource for a given product. 

 

In addition you will serve as a Clinical Leader designing clinical development plans and individual clinical studies from Phase 0 to Phase III and be fully accountable for clinical trial design and leading the clinical development team through study execution. You will provide clinical support and guidance in investigator selection, study initiation and study conduct, patient/subject safety or oversees CRO medical monitor.  Reviews safety and efficacy data, leads the study team through analysis and interpretation of the study results, and makes recommendations as to appropriate next steps. 

 

This open position will be within the Immunology Therapeutic Area.

 

Other duties:

• Trains and mentors clinical study staff on the clinical aspects of the product and its indications.  Leads a team of clinical study physicians also accountable for their respective clinical trials. Responsible for the clinical/medical leadership of INDs, NDAs, BLAs and other global regulatory filings.  Provides clinical leadership and expertise in meetings with Health Authorities globally.
• Lead intra- and inter-departmental teams, matrix-manage a cross-functional team with integrity, flexibility and excellent communication skills.
• Ability to interpret the significance of preclinical and clinical data, and to anticipate the information that will be needed to satisfy regulatory requirements. Ability to progress projects safely and efficiently. Know when to seek advice from colleagues and senior management.
• Build and lead clinical teams and determine what resources and talents are needed for the rapid progression of the project. Interact effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills. Able to secure, manage and maintain critical partnerships with key business partners.
• Form collaborations with key external experts to take world-class science and deliver meaningful benefits for patients.
   

Mostly remote opportunity with occasional onsite days required when business critical.

Qualifications

What you will bring to the role:

• Doctor of Medicine, MD or PhD in Immunology
• Minimum 5 years of experience with R&D clinical development in a pharmaceutical industry (on the sponsor side) with at least 2 years of R&D development in Immunology (Gastroenterology, Rheumatology, Respiratory, Immuno-Oncology)

 

Preferred Qualifications:

• Proven track record of designing and leading studies from early stage through regulatory submission
• Experience in interactions with global health authorities (FDA, EMA, PMDA)
• Knowledge of IBD pipeline and global and national network of IBD KTL’s
• Board certification and/or 2+ years of experience in R&D clinical development in Gastroenterology or Immuno-Oncology therapeutic area
   

Function

Sub Function

Reports To

Vice President, Global Specialty R&D, Respiratory/Immunology TA Head

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