Teva Pharmaceuticals
Director Clinical Development
Teva Pharmaceuticals, Parsippany, New Jersey, us, 07054
Teva Pharmaceuticals - Director Clinical Development - Parsippany, New Jersey
Parsippany, United States, New Jersey, 07054Job Id: 57466Who we areTogether, 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.The opportunityThis role can be based in Parsippany, NJ or West Chester, PA.The 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 lead cross-functional teams in a matrix environment.The individual is expected 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 will provide input to the clinical development plan and leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, early clinical, and pre-clinical development. 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 dayFoster relationships with opinion leaders in assigned Respiratory/pulmonary/atopic disease areas.Be a core member of the Global Project Team.Maintain expertise necessary for the clinical development of the product.Prepare and manage multiple Clinical Development Plans.Lead or oversee the cross-functional clinical development team.Support Global Clinical Operations in clinical trial initiation, resource planning, study implementation, and successful completion.Make presentations at Investigator Meetings and other relevant internal or external venues.Secure the required human resources to implement the Clinical Development plan.Work with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement.Ensure clinical trials comply with clinical guidance, ICH, GCP, and relevant laws.Resolve safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance.Oversee the preparation of documents for IND/NDA and other regulatory submissions.May lead an NDA submission team independently, as needed.Partner cross-functionally with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global Clinical Operations, and CROs.Analyze and interpret clinical results and provide guidance to prepare high-quality reports with Medical Writing.Work with Medical Writing team to author protocol synopses and provide input on clinical documents.Author and/or review abstracts, posters, and manuscripts; present data at scientific meetings as needed.Represent Teva at Scientific meetings, advisory boards, and meetings with regulatory agencies as needed.Your experience and qualificationsMD, 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 in a fast-paced, multi-tasking environment.Travel: Approximately 30%, both domestic and international, as needed.Enjoy a more rewarding choiceWe 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 CommitmentTeva 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.
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Parsippany, United States, New Jersey, 07054Job Id: 57466Who we areTogether, 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.The opportunityThis role can be based in Parsippany, NJ or West Chester, PA.The 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 lead cross-functional teams in a matrix environment.The individual is expected 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 will provide input to the clinical development plan and leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, early clinical, and pre-clinical development. 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 dayFoster relationships with opinion leaders in assigned Respiratory/pulmonary/atopic disease areas.Be a core member of the Global Project Team.Maintain expertise necessary for the clinical development of the product.Prepare and manage multiple Clinical Development Plans.Lead or oversee the cross-functional clinical development team.Support Global Clinical Operations in clinical trial initiation, resource planning, study implementation, and successful completion.Make presentations at Investigator Meetings and other relevant internal or external venues.Secure the required human resources to implement the Clinical Development plan.Work with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement.Ensure clinical trials comply with clinical guidance, ICH, GCP, and relevant laws.Resolve safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance.Oversee the preparation of documents for IND/NDA and other regulatory submissions.May lead an NDA submission team independently, as needed.Partner cross-functionally with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global Clinical Operations, and CROs.Analyze and interpret clinical results and provide guidance to prepare high-quality reports with Medical Writing.Work with Medical Writing team to author protocol synopses and provide input on clinical documents.Author and/or review abstracts, posters, and manuscripts; present data at scientific meetings as needed.Represent Teva at Scientific meetings, advisory boards, and meetings with regulatory agencies as needed.Your experience and qualificationsMD, 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 in a fast-paced, multi-tasking environment.Travel: Approximately 30%, both domestic and international, as needed.Enjoy a more rewarding choiceWe 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 CommitmentTeva 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.
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