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Responsibilities:
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The role will have responsibility for executing and refining organizational strategies for multiple Clinical Trial Materials (CTM) and the necessary management competencies, to ensure of a continuous product supply for drug products (IMP) in support of clinical trials worldwide.
CTM Management competencies include Forecasting and Planning, Packaging and Labeling, Global Distribution, IRT Technology, Outsourcing Management, Capacity and Performance Metrics, Project Management, and Conformance of Quality and Compliance requirements.
As a Karyopharmer, reporting to The Director of Clinical Supply, you will positively impact patients’ when you:
- Coordinate internal teams responsible for US and international clinical distribution with CMOs
- Develop manage and implement CTM supply plans, integrated with clinical trial timelines, including assignment of resources, for sponsored and IST clinical trials. Oversee the creation and review the clinical supply and demand forecasts based on strategic elements/study forecasts from Clinical Operations for studies and/or programs
- Aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast, ensuring a supply chain capable of supporting multiple complex phase III
- Identify the most suitable CRO/CMO and initiate contracts. Oversee work assignment and deliverables for CTM suppliers, and collaborate on and review of pre- and post-executed batch records to ensure timely completion of CTM milestones and internal development work.
- Oversee the distribution/logistics activities of complex supply chains by evaluating supply strategies, tracking inventories, tracking expiry dates, initiating bulk shipments, and coordinating import/export requirements to minimize time to drug availability at sites
- Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered
- Oversee global label development strategies and packaging timelines
- Oversee IRT selection and implementation, including development of internal User Acceptance Testing plans which augment and operate in conjunction with the vendor UAT to ensure the IRT is in line with clinical trial needs
- Develop and maintain companywide metrics for Clinical Supply. Identify gaps in departmental procedures, and design and implement gap
- Develop and implement harmonized best practice policy and operational procedures that are in- line with the integration of Clinical Operations and CTM supply needs of managed clinical studies.
- Build new or advanced expertise to match up with CTM supply needs driven by the clinical program dynamics, new therapeutically area(s) and product development
- Manage operating budgets for outsourced services and activities. Lead initiatives for generation, refinement and maintenance of clinical supply infrastructure and cross- functional
- Ensure department compliance with ICH, Federal U.S. and any pertinent local regulations and adhere to internal SOP and Guidance
Qualifications:
- Bachelor’s degree in life sciences or business major with 10+ years of clinical supply management experience in the pharmaceutical field or an MS degree with 8+ years of experience
- Relevant experience will include: selection/implementation and management of IRT systems, label design, labeling and packaging operations, supply chain CMO
- A thorough understanding of the clinical trial process and clinical trial supply chains
- Experience CMO management, including labeling, packaging, and distribution in North America and Europe
- Knowledge of cGMPs and relevant FDA and EU Regulations
- Familiarity with US and EU regulatory agencies and their guidance as they pertain to clinical supplies
- Effective communication (oral and written) internally and externally with vendors and partners
- Ability to multi-task and work in a fast paced and dynamic environment
- Strong working knowledge of standard business software, including MS Excel, Word, PowerPoint and Project
- Strong analytical and/or organizational skills
Overview:
Our Karyopharmers live and demonstrate our ICARE values every day!
#ThisIsWhyKPTI
Karyopharmers are passionately driven in our mission to positively impact patients’ lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!
What We Offer:
In addition to our exciting, supportive, and intellectually challenging global workspaces(s), Karyopharmers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.
- A fun, collaborative, work environment
- A culture of employee engagement, diversity, and inclusion
- Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
- Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), and tuition reimbursement.
- Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
- Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development programs, and a variety of reward and recognition programs)
- Cell phone allowance
- Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment
- This position is eligible for remote/hybrid working arrangement (may work from home/virtually; may also work hybrid on-site-virtual as required/approved by hiring manager.
ABOUT KARYOPHARM
WE ARE COMMITTED TO DE&I
