Newly created position for Director of PM with biopharmaceutical /device industry experience spanning from pre-IND to NDA through to launch. This team leader will integrate, manage and guide project deliverables and provide project direction related to all nonclinical, clinical and device development programs from all respective disciplines in the company (Nonclinical, CMC, Clinical, Device Development, Regulatory Affairs). Additionally, the team leader will oversee and provide project management related support to project teams to meet overall corporate objectives leading to successful development / submission / launch. This role requires effective and efficient interactions with all internal stakeholders as well as potentially external stakeholders such as CMOs, CROs and any other vendor as required for a program deliverable.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop overall project plans for all development programs including oversight of all project timelines with Regulatory Affairs integration
Implement activities including scheduling, organizing and managing team meetings with tracking of ongoing study progress
Track and manage project deliverables according to overall program timeline and goals including cost tracking support for all projects as required
Support the integration of alliance team projects and represent Antares as project manager in alliances
Create and circulate status reports as required
Integrate 3rd party contractors and external project managers where required
Ensure that corporate goals and timelines are appropriately managed and achieved
B.A./B.S./M.S. in Biology, Pharmacy, or related Scientific discipline from and accredited college or university.
Project Management certifications preferred
Minimum 5 years pharmaceutical experience with broad knowledge spanning from pre-IND to NDA and through commercial product launch.
Biopharmaceutical and / or drug-device combination experience preferred
Experience with Microsoft Project / Gant charts and timeline development
Experience integrating with alliance partners and external service providers
Cross-functional skills to work with all pertinent internal functions
OTHER SKILLS AND ABILITIES:
Rapidly acclimatizes to new environments and projects
Demonstrate project management skills with strength guiding cross-functional teams
Effective communication and interpersonal skills with senior management, interdisciplinary project teams, subordinates and external vendors
Good working knowledge of US and Canadian regulations
Must possess sound judgment and discretion
Solutions oriented individual willing to present solutions vs. problems