Director, Clinical Supply Chain at Ultragenyx in Novato, CA

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

Reporting to the Head of Global Planning, Ultragenyx is seeking a highly motivated Director of Clinical Supply Chain with expertise in end-to-end pharmaceutical clinical supply strategies and operations. In this position you will be responsible for development, management and execution of demand and supply plans for priority clinical programs, and all associated studies. You will partner with Clinical Operations, Manufacturing, Packaging and Labeling, Regulatory, Quality and Program Management to supply clinical sites internationally.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

Accountable for end-to end clinical supply chain responsibilities, including but not limited to, study design and operation input regarding supply, multi-stage (i.e., from raw materials through finished goods) demand and supply planning, inventory management and distribution.
Develops strategies to ensure robust clinical supply throughout clinical trial duration in collaboration with Clinical Operations, Manufacturing, Packaging, Quality Assurance, Regulatory, and Project Management. Proactively plans for expiry and remaining shelf-life requirements to meet country, site and patient requirements and minimize obsolescence.
Leads the Demand & Operations Planning (D&OP) process, including presenting in the D&OP meeting, participation in pre-D&OP meetings, compiling, and validating data, generating supply plans and reports/dashboards, and creation of meeting content.
Establishes and over sees production forecasts for contract organizations, liaise with Contract Organization (CO) business owners to ensure schedules meet plan objectives and adhere to CO requirements.
Supply Chain lead on designated clinical product CMC teams, maintains strong communication between Supply Chain and the CMC team.
Coordinates and provides oversight of distribution of Investigational Medicinal Products (IMP) to depots and sites, as well as import and export of GMP materials.
Superuser for advanced planning system (Kinaxis). Requires SME level knowledge of system capabilities, process, and ability to troubleshoot basic issues. Owns clinical product master data, including planning attributes requiring understanding impact of attributes to the supply plans.
Manages contracts/SOWs/purchase orders with CMOs for storage and distribution and other related clinical supply activities.
Directs projects, including acting as project team lead, for activities related to clinical product supply.
Accountable and responsible for clinical inventory reconciliation and destruction at depots.

Requirements:

Bachelor’s degree in biotechnology, Supply Chain, Engineering or related STEM discipline; MBA or similar Master’s degree strongly preferred.
5 – 8 years of supply and / or demand planning experience
Minimum of 5 years of experience in biotech / pharmaceutical industry
Experience with Kinaxis, SmartSheet, PowerBI and Oracle or similar systems; proficient in quality event documentation practices and Veeva QMS
In-depth understanding of CMC, quality, clinical operations, and blinding practices, and IRT/IWRS systems
Working knowledge of cGXP’s and pharmaceutical industry procedures and regulations, including import and export requirements
Experience in building new processes and establishing standards
Demonstrated ability for analytical and systematic thinking. Strong problem-solving and decision-making skills
Ability to lead mid-size projects through the change management process and the use of project management tools
Travel: approximately 10% #LI-CS1 #LI-Remote

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$197,600—$244,100 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.