Director/Sr. Director Global Specialty Development, Neurodegenerative Diseases
The Director/Sr. Director is responsible for the development, execution and management of multiple clinical programs worldwide across all phases of clinical research in the areas of Neurodegenerative Diseases (NDD). Reporting to the VP, Global Head of NDD Clinical Development, the Director/Sr. Director will oversee clinical study teams, represent the clinical development department in functional area 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). He/she will be the point person for all clinical questions (e.g. methods, safety) that arise on specific protocols and programs under his/her responsibility.
Key responsibilities include:
- The Director/Sr. Director will responsible for the clinical development plan and will provide leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, and pre-clinical development in this regard.
- The Director/ Sr. Director will be a key contributor to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. The Director/Sr. Director will engage in scientific interactions foster relationships with opinion leaders in the field of migraine and headaches.
- 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
- Responsible for identifying human resources requirements 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 Pharmacovigliance, VP Clinical Research and the Head of the Global Respiratory Therapeutic Area as needed.
- Oversees the preparation of documents for IND/NDA/MAA and other regulatory documents
- May lead an NDA/MAA submission team independently, as needed
- Partners cross-functionally with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, GCO, and GCPR in the execution of Clinical Development Plans
- Capable of analyzing and interpreting clinical results and provide a guidance to prepare high quality reports working with Medical Writing
- Responsible for authoring protocol synopses and working with Medical Writing. Provides 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
- MD, DO or equivalent combination of education and related work experience. PhD, PharmD with strong proven track record will be considered
- At least 3 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 neurodegenerative disease, movement disorders, rare diseases (CNS) therapeutic areas is strongly preferred (Huntington’s Disease, Parkinson’s disease, Alzheimer’s disease, Motor Neuron Disease/ALS)
- Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks, 2-4 years of managerial experience preferred
- Strong sense of urgency and understanding of time pressures, ability to thrive and enjoy working independently in a fast-paced, multi-tasking environment
If interested, please call/send CV to:
Sr. Strategic Sourcing Partner