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Director Clinical Development
3 months ago
Date: Aug 2, 2024
Location: Parsippany, United States, New Jersey, 07054
Job Id: 57466 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
Director, Clinical Development is responsible for the development, execution and management of several clinical programs worldwide across all phases of clinical research. The individual will oversee study teams and will be responsible for leading cross–functional teams in a matrix environment.
The individual is expected to be able to function independently in the daily management of clinical research projects including the preparation/review of related key documents (i.e. protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions).
The Director, Clinical Development will provide input to the clinical development plan and will provide leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, early clinical and pre–clinical development in this regard. The Director will be a key contributor to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. How you'll spend your day
The Director, Clinical Development will foster relationships with opinion leaders in assigned Respiratory/pulmonary/atopic disease areas.Will be a core member of the Global Project Team.Will have and maintain the expertise necessary for the clinical development of the product.Prepares and manages multiple Clinical Development Plans.Leads or oversees the cross–functional clinical development team.Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion.Makes presentations at the Investigator Meetings and other relevant internal or external venues.Responsible for securing the required human resources to implement the Clinical Development plan.Works with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement.Ensures 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 Pharmacovigilance, SVP Late Clinical Development and the Disease Area Heads, as needed.Oversees the preparation of documents for IND/NDA and other regulatory documents.May lead an NDA submission team independently, as needed.Partners cross–functionally with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global Clinical Operations, and CROs in the execution of Clinical Development Plans (CDPs).Capable of analyzing and interpreting clinical results and provide guidance to prepare high quality reports working with Medical Writing.Working with Medical Writing team, responsible for authoring protocol synopses, providing input and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant clinical documents.Author and/or review abstracts, posters and manuscripts, present data at scientific meetings, as needed.Represent Teva at Scientific meetings, advisory boards, KOL boards and meetings with regulatory agencies, as needed. Your experience and qualifications MD, DO or equivalent combination of education and related work experience. PhD, PharmD, DVM with strong proven track record will be considered.Minimum of 2 years' experience in a pharmaceutical industry environment or related area planning/managing clinical trials, with proven ability to manage projects and/or lead project teams effectively. MD/DO without prior industry experience but with relevant knowledge and expertise in clinical trials will be considered.Experience in the Respiratory/pulmonary/allergy therapeutic area is strongly preferred.Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks preferred.Strong sense of urgency and understanding of time pressures, ability to thrive and enjoy working independently in a fast–paced, multi–tasking environment. Travel:Approximately 30%, both domestic and International, as needed. Enjoy a more rewarding choice We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance. Teva's 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. We are committed to a diverse and inclusive workplace for all.
