The opportunity
This role can be based in Parsippany, NJ or West Chester, PA
Senior 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 Sr. 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 Sr. Director, Clinical Development 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 Senior Director:
Will foster relationships with opinion leaders in assigned Respiratory/pulmonary/allergy disease areas.
Will work with external co-development partners, CROs and other development partners to manage ongoing and planned clinical development programs (i.e. individual studies and multiple studies in a program, as applicable)
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 with the clinical supplies group
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, development partners and CROs in the execution of Clinical Development Plans (CDPs)
Capable of analyzing and interpreting clinical results and provide a 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
