CMCPM Radiopharmaceuticals

Role Summary

CMCPM Radiopharmaceuticals

Responsibilities

• Effectively partner with global program teams and therapeutic business units to translate preclinical, clinical, and asset strategy into CMC development & delivery goals (working closely with asset leadership, PPM, clinical/medical, and regulatory partners).
• Lead the creation, development, communication and implementation of integrated CMC plans for assets from portfolio entry through early-phase clinical development (inclusive of both therapeutics and imaging agents)
• Leverage portfolio knowledge, development and financial acumen to enable investment strategies and optimization at both project and portfolio level.
• Drive cross-functional CMC teams to maximize the value of data, create bold, competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions.
• Understand when and how to appropriately raise issues to teams and to stakeholders. Keep both team members and stakeholders fully apprised of project status and issues at the right level of detail.
• Develop high performing matrix teams with an ability to quickly identify gaps in team effectiveness and implement remediation efforts to ensure project success.
• Support Due Diligence efforts by leading CMC development plans while integrating and communicating key findings with stakeholders.
• Participate in or lead continuous improvement projects, which significantly impact the work and/or effectiveness of CMC development.

Qualifications

• Required: 10+ years of drug development or radiopharmaceutical product experience
• Required: Four-year degree, preferably in a scientific or engineering field
• Required: Practical experience leading cross-functional projects, preferably within radiopharmaceutical CMC.
• Required: Demonstrated expertise in PM tools and processes (e.g. management of scope, timeline, cost, communications, risk and procurement as defined by PMBOK), with ability to identify and drive business process improvements and incorporate new PM technologies/methodologies
• Required: Demonstrated ability to communicate complex issues accurately and succinctly, both horizontally and vertically across the development organization

Preferred Skills

• Advanced degree (Master of Science, Master of Business Administration, Ph.D. or PharmD.)
• Understanding of development phases, associated radiopharmaceutical CMC deliverables, and interactions of various functional areas and how each relates to a comprehensive development strategy
• Experience in clinically-enabling radiopharmaceutical CMC development, inclusive of therapeutics and imaging
• Understanding of early- & late-phase therapeutic landscapes, incl. clinical & regulatory environments

Education

• Four-year degree required; advanced degree preferred

Additional Requirements

• Physical Demands/Work Environment: The physical demands of this position are consistent with light office duties, performed in a typical office setting.
• Location: Remote or onsite