Company Description
Job Description
We are seeking a Director in Clinical Supply Chain to be part of our Supply Chain team. This individual will lead the clinical supply chain team and manage end-to end clinical supply activities for our early and late-stage programs. This position will design, develop, and implement clinical supplies strategies to ensure appropriate continuous supply of material. The successful candidate will work closely with Clinical Operations, Quality Assurance, Regulatory Affairs, and third-party CMOs. Strong cross-functional team leadership and project management skills are essential requirements of the role.
This position will report to the Senior Director, Supply Chain Management and be in the Waltham, MA office or Hybrid.
The Role:
Responsible for all levels of studies, ranging from simple and complex, requiring in-depth understanding of GMPs and global Health Authority requirements, project management, IRT, medication management and/or use of advanced simulation tools.
Exhibit leadership capabilities to manage and develop Clinical Supply Managers of all experience levels by aligning team goals with organizational objectives.
Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies, workflows, and priorities in response to changing business needs, technologies, and stakeholder expectations.
Ability to manage budgets, analyze cost-effectiveness, and ensure financial goals are met.
Manage external consultants and third-party vendors, including collaborating with QA on vendor selection and quality and supplier agreement development, to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements.
Interpret clinical trial drug requests and protocols and develop clinical packaging strategies, timelines, and budgets.
Responsible for scheduling and delivery of CTM including strategies for creating label and packaging design, randomization, packaging, labelling and distribution of clinical supplies.
Contribute to protocol development.
Contribute to IRT system design for areas related to drug supply management and participate in related system activities from user acceptance testing to archival.
Operate closely with logistics function to proactively plan, document, and facilitate global cross border distribution strategies.
Coordinate primary and secondary packaging, labeling, testing, distribution and return drug management activities with CMO's.
Interface with QA, RA, CMC/manufacturing to ensure trial supplies are appropriately supported including shelf life, quantities, country approvals and specification.
Develop and manage the forecasting and ordering investigational product, commercial and comparator material in global trials.
Proactively find solutions to emerging issues in an effective manner while taking into consideration risks and cost-effectiveness.
Independently create clinical supply study budgets and monitor spend to-date compared to the approved study budget.
Develop new functional SOPs, Policies/Plans as necessary.
Demonstrate behaviors that fosters Deciphera's "PATHS" core values.
Identify gaps and makes appropriate mitigation recommendations to ensure business continuity.
Qualifications
What You'll Bring:
10 + years of clinical supply chain experience in the pharmaceutical industry supporting complex global trials
Bachelor's degree in supply chain, engineering, life sciences, or a related field; advanced degree preferred
Demonstrated ability to support and empower team members through fostering autonomy, building trust, and delegating responsibilities effectively to promote growth and success.
Results driven with proven ability to perform in a fast-paced environment
High attention to detail and demonstrated ability to manage and prioritize multiple competing tasks
Experience working cross-functionally with CMC, regulatory, clinical operations, and clinical development
Experience managing contract development and manufacturing (CDMO) partnerships
Effective listener who maintains successful communications with internal and external stakeholders including on issue escalation, responding to inquiries and concerns
Ability and willingness to travel (up to 10%) to industry partner sites
Ability to identify and appropriately resolve issues
Collaborative leader who can influence across business and external partners
Excellent verbal and written communication skills, with the ability to build productive long-term team relationships at all levels of supplier organizations, including with senior executives
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $180,000.00 - $248,000.00. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).
Benefits:
Competitive salary and annual bonus.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
Generous parental leave and family planning benefits.
Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
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