Senior DirectorDirector, CMC Project Management
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Job Location:
Waltham, MA - USA
Monthly Salary:
$ 250000 - 306000
Posted on:
2 days ago
Vacancies:
1 Vacancy
Department:
Job Summary
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
The Senior Director/Director CMC Project Management is responsible for leading and coordinating the strategic planning integration and execution of the companys CMC development programs across the portfolio. This role serves as the central program leadership function within Technical Operations and Quality Assurance driving cross-functional alignment integrated planning and disciplined execution from early development through clinical and commercial milestones.
Reporting to the Chief Technical Operations & Quality Officer this individual will partner closely with Technical Operations Regulatory Quality Clinical and Finance to ensure CMC programs are delivered on time within scope and aligned with corporate objectives. This role is best suited for a strong program leader with deep experience in CMC project management governance and cross-function team leadership in a matrixed biotech environment.
Responsibilities:
Strategic Leadership:
- Lead and manage a portfolio of strategic CMC projects ensuring alignment with enterprise priorities
- Define clear strategic priorities project milestones performance standards and expectations across a matrixed cross-functional team of key stakeholders
- Act as a trusted liaison between executive leadership and project teams translating strategic goals into actionable plans
- Ensure consistent application of project management best practices including integrated project plans timelines risk registers and governance
- Review and challenge project strategies critical paths and risk mitigation plans; escalate issues and trade-offs as needed
- Drive effective transition of projects from Research into Technical Operations and onward to commercial manufacture
- Partner cross-functionally with Manufacturing Analytical Development Quality Regulatory External Supply Procurement Finance Clinical and Commercial stakeholders
- Partner with CDMOs and external vendors to ensure aligned execution transparent communication and risk management
- Enable proactive portfolio visibility through integrated project plans scenario planning and resource forecasting
Operational Excellence
- Identify Establish and continuously improve project management processes tools metrics and operating models across Technical Operations to improve efficiency
- Identify capability gaps capacity constraints and opportunities for operational excellence
- Drive adoption of standardized tools and frameworks for program tracking and reporting
- Champion a culture of inclusion continuous improvement and operational excellence
Financial & Resource Management
- Support development and accountability to budget and other financial planning deliverables across the function
- Optimize resource utilization and monitor KPIs to assess program health and impact
Communications & Stakeholder Engagement
- Prepare executive-level dashboards or MS PowerPoint milestone timelines to communicate progress and escalate risks
- Serve as communications conduit to external partners and internal cross-functional project teams including executing project tasks and details
- Coordinate and document agenda and meeting notes to ensure smooth execution of functional activities and extended leadership meetings
Qualifications:
- Bachelors degree advanced degree preferred in Chemistry Chemical Engineering or related field
- 12 years of experience in pharmaceutical or biotech industry with at least 3 years in CMC project management or related technical operations role or equivalent experience
- Strong understanding of drug substance and drug product development technology transfer and GMP manufacturing
- Small molecule and solid oral dosage form experience preferred.
- Experience managing external partners (CMOs/CDMOs)
- Working knowledge of regulatory CMC requirements (FDA ICH)
- Decision Making has a systematic and methodical approach to making decisions obtains relevant information thinks beyond the immediate decision point challenges assumptions and considers business implications of potential solutions
- People Leadership - Ability to lead and influence effectively
- Strong analytical problem-solving and planning skills
- Exceptional organizational and communication skills with the ability to work independently and collaboratively across all levels of the organization
- Positive Change Agent curious adaptable and energizing leader with a global mindset
- Culture Ambassador - champions and models the organizations values fostering a culture of quality inclusion and continuous improvement across all teams
- Proficiency with project management tools (Smartsheet strongly preferred)
- Strong problem-solving critical thinking and risk management skills
- Ability to thrive in a fast-paced dynamic environment with shifting priorities
Work Environment:
- The position is hybrid working out of the Waltham MA or Newark CA location.
- Travel is estimated at 15 % but will flex depending on business need.
The anticipated annualized base pay range for this full-time position is $250000 - $306000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision)life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Required Experience:
Exec
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
