Spirovant is looking for a Senior Director who has experience in non-clinical and clinical pulmonary drug delivery. The successful candidate will be responsible for the selection of pulmonary delivery devices (including inhalation, intra-nasal, intra-tracheal) for non-clinical development programs and subsequently for clinical trials based on in vitro and in vivo characterization datasets.
The candidate will be responsible for identifying laboratories (academic or CRO) to conduct needed studies and for establishing study budget and timelines.
The candidate will work closely with the CMC function to optimize formulations for pulmonary delivery. They will also work closely with the nonclinical and clinical development groups to facilitate method development and protocol generation for in vivo studies.
The incumbent will also be expected to draft nonclinical regulatory documents for INTERACT, preIND, IND, EoPII, NDA/BLA filings etc., and represent the device component on internal project team meetings.
RESPONSIBILITIES
- Selection of appropriate non-clinical pulmonary delivery device(s) for use in studies for advancing candidates to global registration.
- Interface with contract research organizations (CROs) to request quotes for selection of testing labs and serve as technical interface between outsourced entities and Spirovant.
- Conduct detailed technical evaluations of device(s) to support each of the gene-therapy modalities within the Spirovant pipeline, as well as assist in due diligence and licensing activities.
- Define device development plan(s) and establish timelines and budget for a comprehensive integrated overall asset development plan.
- In collaboration with the CMC function, work to identify optimal formulations for pulmonary drug delivery.
- In collaboration with relevant stakeholders develop strategies for global registration.
- Provide SME support to other individuals / groups within Spirovant as needed.
- Participate in the scope-creation, execution, and oversight of Strategic Research Agreements with external collaborators.
- Provide oversight to external device consultants, as needed.
REQUIREMENTS:
- MSc or PhD in relevant biological or mechanical sciences.
- Minimum 8+ years pharmaceutical or CRO industry experience with inhalation devices.
- Knowledge of or prior experience in device development strategies, and development phase-appropriate regulatory requirements.
- Experience in nonclinical aspects of gene therapy (strongly preferred), biologics, or vaccine development.
- Aerosol physics background preferred, but not required.
- Excellent written and oral communication skills.
- Proven ability to independently manage multiple projects/tasks at one time.
- Ability to travel to CRO partners, and Philadelphia main office, on an as-needs basis (up to 30% of time).
Spirovant is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.