Onsite 2-3 times per week in either Oceanside, CA OR Foster City, CA-
Relocation assistance provided
Must have: Clinical trail vendor sourcing (Biopharma/Pharma background)
We are a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining us, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. The Sr. Manager, Comparator Sourcing works collaboratively with internal teams (Clinical Supply Chain Management (CSCM), Pharmaceutical Development and Manufacturing (PDM), Clinical Operations, Finance, Regulatory, Quality Assurance (QA), Development and Business Operations) and external vendors to develop comparator sourcing strategies for clinical studies, meet project deliverables, and solve business problems.
· Collaborates with supply chain planners and external vendors on comparator supply managing activities, including providing ordering schedule, and comparator sourcing plan according to study timelines and/or marketing needs
· Proactively identifies risks and creates strategies to avoid any impact to study timelines
· Acts as the operational point of contact for comparator vendors including continuous oversight of the assigned comparator drugs, managing the comparator portfolio assignments to suppliers, leading joint operations meetings with comparator suppliers to address day-to-day topics, and identifying continuous improvement opportunities
· Evaluates and improves sourcing strategies (frequency, supplier, quantities) for comparators used in clinical studies by leveraging market intelligence, demand forecasts, IRT reports, distribution plans, simulation tools, and real-time availability
· Initiates process improvement activities, ensures alignment, and streamlines communications with internal and external cross-functional groups such as QP, Regulatory, Finance, etc.
· Leads the selection of new procurement vendors to provide/ensure study drug continuity, coordinates with supplier compliance (audits) and aligns vendor processes for the CSCM planners
· Keep abreast of all incidents related to comparator drug shipments and reports trending to Quality Assurance and supports the resolution of CAPAs
· Responsible for maintaining GDP, GMP and global trade compliance
· Collaborates with Logistics management and other members of CSCM, PDM, and external partners to resolve comparator sourcing shipping related issues; escalates to senior leadership as needed
· Revises and author SOPs and Work Instructions with manager direction and support.
· Obtains and reviews quotes, approves purchase requisitions, and invoices.
Knowledge and Skills:
- Possesses solid experience in sourcing and managing comparator drugs and other co-meds for clinical studies.
- Strong knowledge of supply chain considerations (sourcing, manufacturing, distribution, quality, regulatory, finance, clinical operations)
- General understanding of clinical trial design, drug technical development, IRT functionality, demand forecasting, import/export, and supply planning techniques
- Possesses extensive knowledge of comparator sourcing strategies (e.g., central sourcing, site sourcing, Pharmacy cards, among others)
- Mature knowledge of the FDA, cGMP, GCP standards and regulatory guidance documents.
- Possesses collaboration, influencing and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet aggressive clinical study timelines and patient needs.
- Ability to lead in an agile, fast-paced environment with flexibility, empowerment, integrity, and authenticity
- Works well with ambiguity, can assess options quickly and efficiently implement the best option (e.g., wholesaler, supply agreement, collaboration agreement) in alignment with culture and expectations for clinical timelines
- Strong analytical and problem-solving skills, with advanced knowledge of Excel or other similar tools. Project management experience is a plus.
- Excellent verbal, written, and interpersonal communication skills, with the ability to simplify complex topics into key messages for senior leadership
- Ability to mentor planners in evaluating the risk/reward tradeoffs in the timing of comparator purchases given known business intelligence on product availability
- Demonstrated ability to lead process improvement activities; delivering business processes and/or technical solutions that satisfy multiple sets of stakeholders