Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit a Manager Pharmaceutical Sciences/CMC Program Management.
- Independently leads development of Pharmaceutical Sciences (PS) strategy and plans for multiple programs.
- Leads/contributes to functional strategy and initiatives.
- Clearly communicates portfolio development to stakeholders.
- Serve both as a member of the Global Product Team and the Global CMC Team Lead, facilitating the cross functional team inclusive contributors from API, Formulations, Analysis, Regulatory, QA, Clinical Supplies, Commercial Supply Chain, and CROs/CMOs/other vendors.
- CMC Plan development, schedule development, budget estimation, risk assessment and issue management and cross-functional communications
- Leads multiple global PS teams while ensuring the defined scope, budget, and timelines of the program(s) are met with high-quality deliverables.
- Participates as functional expert in divisional initiatives.
- Leads/represents PS on cross-divisional governance and development teams while providing strategy and accountability for PS deliverables.
- Leads the preparation of the PS sections of global regulatory submissions (e.g. CTAs and commercial applications) and PS responses to regulatory agencies; represents PS at meetings with regulatory agencies as necessary.
- Manages PS development activities being performed by a contract lab or manufacturing facility to ensure project deliverables are being met; reviews contracts and invoices as necessary.
- Identifies and communicates project or program risks and provides risk response strategies in a timely manner to appropriate stakeholders and PS management.
- Identifies, evaluates, develops and communicates/negotiates criticality of new scientific standards and tools for potential implementation on programs.
- Applies scientific knowledge and principles to solve project problems and significantly influence the direction of projects/programs.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.