1+ months

Senior Director, Clinical Development (Headache TA)

Frazer, PA 15084
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

The Senior Director, Clinical Development - Headache reports directly to the Vice President, Clinical Development - Headache, within Teva R&D, Specialty Clinical Development, and supports assigned drug development projects, including the planning and implementation of one or more clinical programs worldwide and across all phases of clinical discovery and development.  

Specifically, the Senior Director works within a cross-functional matrix environment to provide clinical leadership and medical oversight for a global development team.  The individual functions independently in the daily management of clinical research projects, including medical monitoring of clinical studies, the interpretation of study data and safety findings, as well as the preparation of key study documents (i.e. Protocol, Investigators Brochure, Clinical Study Report, and regulatory submissions).  The Senior Director will provide clinical leadership in the development of the assigned asset strategy and clinical development plan, working closely in this regard with other functional areas such as Commercial, Regulatory Affairs, Pharmacovigilance, Chemistry Manufacturing and Controls, Medical Affairs, and pre-clinical development.  The Senior Director will be a key contributor to and responsible for the clinical aspects of INDs, NDAs, BLAs, and other global regulatory filings. The Senior Director will foster relationships with key opinion leaders/external experts within the assigned Therapeutic Area.   

Maintains the expertise necessary for early and late stage clinical development of headache medicines

Participates as a core member of the global team that supports strategic development of assigned assets

Prepares and manages multiple Clinical Development Plans

Ensures that clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating Procedures
Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigliance, VP Clinical Research and the Head of the Global Therapeutic Area as needed

Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion
 

Qualifications

MD, DO, PhD or equivalent combination of education and related work experience

Experience in Research and Development of medicines of at least 8 years, + and with direct experience in developing and directing clinical trials of at least 5 years.

Clinical experience in headache medicine and/or strong experience in clinical development in the therapeutic area of headache is highly preferred

Board certification and medical training preferred

Proven track record of leading studies from early stage through to regulatory submissions

Must be an excellent scientific and clinical writer, and have a track record as the primary author of peer-reviewed publications

Must be highly proficient in the preparation and oral presentation of clinical R&D material

Must have a track record of leading cross-functional teams to achieve clinical discovery objectives on aggressive timelines, and to navigate the needs and concerns of clinical investigators and clinical research contractors 

Must be recognized externally for leadership and excellence in a relevant therapeutic area, through peer-reviewed publications, service in grant review, invited scientific presentations, by regional (Associate Director), national (Director), or international (Sr. Director) organizations and societies 

Must have a track record of delivering innovation and excellence in clinical trial design, execution, and data collection 

Function
Research & Development
Sub Function
Clinical Development
Reports To
In process of validation
Tevas Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Categories

Posted: 2019-08-22 Expires: 2019-11-09

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Director, Clinical Development (Headache TA)

Teva Pharmaceuticals
Frazer, PA 15084

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