Job Description
We are seeking an experienced CMC Project Manager to oversee and drive cross-functional
development programs for small molecule therapeutics. This role will provide leadership and
coordination across CMC, non-clinical, clinical, and regulatory functions, ensuring that
programs are executed on time, within budget, and in compliance with global regulatory
standards. The ideal candidate possesses broad expertise in drug development, strong
organizational skills, and the ability to influence and motivate diverse stakeholders to achieve
program goals.
Roles and Responsibilities
Oversee CMC timelines and deliverable completion for activities that include process
development, manufacturing, analytical methods, formulation, stability, and clinical
supply readiness across multiple suppliers to ensure that materials are delivered on
time and within budget
Develop and maintain integrated project plans covering scope, timelines, budgets,
resources, and risk management strategies
Track progress against milestones, anticipate issues, and implement corrective actions
when necessary
Provide clear, concise updates and presentations to executive leadership, governance
committees, and external stakeholders
Identify and mitigate program risks across technical, regulatory, operational, and
financial dimensions.
Partner with Regulatory Affairs to develop regulatory strategy toward NDA completion
and submission
Drive end-to-end program lifecycle ensuring stakeholder alignment and objective clarity
Qualifications - Requirements
Advanced degree in life sciences, pharmaceutical sciences, or related field (PhD,
PharmD, MS, or equivalent strongly preferred).
8 12+ years of experience in the pharmaceutical/biotech industry, with at least 5 years
in program management.
Proven track record managing small molecule development programs through clinical
phases to NDA Submission.
Strong understanding of the drug development lifecycle, from discovery through
commercialization.
Advanced program management skills with experience in budgeting, forecasting, and
scenario planning.
Ability to communicate complex issues clearly to both technical teams and executive
leadership.
Strategic thinker with excellent problem-solving, organizational, and risk management
capabilities.
Strong interpersonal skills with a demonstrated ability to influence without authority to
deliver broad impact
Experience working with senior leadership and presenting to executive stakeholders
Excellent written and verbal communication skills; able to synthesize complex topics
into clear, actionable plans
Highly motivated, detail-oriented, and adaptable in fast-paced, dynamic environments
Prior experience in small molecule pharmaceutical launch
Proven ability to think strategically, plan and align product development with business
goals and market needs.
Naturally accountable, a self-starter, self-motivated, self-directed, self-sustaining.
Outstanding communication and presentation skills, written and verbal, to all levels of
an organization.
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