Director / Senior Director, CMC Clinical Supply Chain

job
  • Shelby American, Inc.
Job Summary
Location
San Diego ,CA
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
16 Feb 2025
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Job Description
Description*Note: exact level depending on experience*Company Overview:Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression.Vividion has been recognized as a Top Workplace by The San Diego Union-Tribune in 2022, 2023, and 2024.Job Summary:The Director or Senior Director of CMC Clinical Supply Chain will be responsible for developing a robust clinical supply packaging, labeling, and distribution network, as well as implementing a long-term strategy for delivering finished drug product globally for the clinical development portfolio. They will lead the team(s) accountable for the seamless execution of complex supply models demanding the highest degree of quality, trade, and financial compliance globally. These activities include management and oversight of the planning, forecasting, sourcing, packaging, labeling, distribution, and return of clinical supplies, as well as direct/matrix line management of other supporting clinical supply staff members. The successful applicant will collaborate closely as an integrated partner with other CMC departments colleagues, as well as a member of cross-functional study teams that include Project Management, Clinical Operations, Clinical Development, and RA/QA.RequirementsEssential Duties and Responsibilities:Manage all aspects of Investigational Product (IMP) and ancillary supplies for global and domestic clinical trials.Oversee IVR/drug distribution vendors, packaging, labeling, reconciliation, destruction, and supply accountability tracking.Develop and implement clinical supply chain strategies to optimize efficiency and minimize waste.Serve as the clinical supply lead for assigned programs and develop/manage the clinical supply chain team as needed.Lead demand forecasting, supply planning, and label development to align with study needs.Partner with Commercial Supply Chain for seamless program transitions and regulatory compliance.Manage the clinical supply budget, prepare financial plans, and present strategic updates to senior leadership.Work with cross-functional teams to develop study-specific IXRS specifications and manage unblinded IP supply activities.Establish key performance indicators (KPIs) and provide regular updates to senior management.Qualifications and Experience:Bachelor’s degree in health or life sciences or equivalent with 15+ years of industry experience in the field of pharmaceutical manufacturing and supply chain, in roles of increasing responsibility directly overseeing finished goods supply pack, label and distribute supply chain activities.Strong managerial and leadership skills, fostering a collaborative and results-driven team environment.Expertise in supply chain systems, clinical packaging, labeling, and distribution within a global biopharma organization.Thorough knowledge of GMP, GCP, ICH guidelines, and global pharmaceutical regulations.Strong negotiation, strategic planning, and problem-solving skills.Experience with IXRS design, implementation, and management.Knowledge, Skills and Abilities:Experience with IXRS design, implementation, testing, and monitoring.Proficiency in Microsoft applications, EDC systems, and inventory management tools.Strong leadership, cross-functional influence, and strategic planning skills.Expertise in finance, risk management, and complex distribution/labeling strategies.Highly organized, creative, self-motivated, and accountable.Strong business acumen with the ability to multitask, meet tight deadlines, and engage professionally at all levels.Skilled in coaching, mentoring, and fostering high-performance teams.Excellent communication, presentation, and critical-thinking skills.Pay & Benefits:The anticipated base salary for this position ranges from $200,000 to $240,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance.EEO & Employment Eligibility:Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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