Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Sr. Clinical Supply Manager Location: Burlington Canada or Remote Department: Clinical PM Reporting To: Director, Clinical Supply Chain for North America Responsible For (Staff): Yes The SMART Services Senior Clinical Supply Manager (CSM) is responsible for developing drug supply planning strategy and overall management of supplies for all phases of clinical trials, including Phase I-IV, Expanded Access Program, Compassionate Use, international to domestic, and all levels of trial and supply chain complexity. The Senior CSM role supports PCI Clinical Service Customers by bringing clinical supply chain management experience and providing expertise throughout the clinical study and program supply lifecycle. The Senior CSM can act as the Client’s single point of contact in coordinating the necessary information cross-functionally within PCI as well as the Client's organization and other external vendors. ESSENTIAL DUTIES AND RESPONSIBILITIES: Forecast clinical supply demand and manage clinical supply inventory throughout the clinical trial globally. Adjust re-supply strategies by assessing clinical protocol revisions and analyzing enrollment rates, inventory usage, and trends. Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies. Work with IXRS vendors in creation of system specification for supply algorithms and manages drug supply portion of IXRS development for clinical trials. Manage clinical supply depot set-up and monitor depot inventory throughout study. Manage clinical drug for a wide range of study types, including packaging design and contingency planning. Build drug projections, distribution strategy, packaging schedules, as well as managing/monitoring depot and site inventory levels. Act as client advocate, assisting with study set-up with CRO. Work in an unblinded capacity with secure, confidential study information. Participate in high level cross-functional teams. Manage the project budget (protocol and program level). Participate in CMC meeting to help manage expectations and ensure clear communication. Supports comparator procurement strategies. Requests manual drug orders as needed. Manage/monitor/procure ancillary and comparator supplies inventories. Provide final drug accountability reports to Clinical group. Coordinate drug return, accountability, and destruction process. Will manage IMP across multiple clinical trials when necessary. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager. QUALIFICATIONS: Required: Bachelor’s Degree and/or 5-7 years Clinical Supplies Experience; majority in Clinical Supply Management at Sponsor Company College Level Mathematical Skills Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. Ability to Travel Preferred: Ability to effectively present information to various people as the job requires. Ability to identify and resolve problems in a timely manner. Ability to display excellent time management skills. Ability to work independently and/or as part of a team. Experience with Clinical Supply Planning, Packaging, and Distribution. #LI-RS1 The base salary hiring range for this position is ($109,360 - $123,030) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
