Job Title: Senior Analyst, Supply Chain
Reports To: Senior Director, Supply Chain
Functional Area: CMC / Clinical Supply Chain
Position Location: Remote (possible hybrid)
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
We are a nimble, driven, and accomplished team of entrepreneurs, physicians, and industry experts with a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead program has completed multiple Phase 1 and Phase 2 clinical trials. We launched our Phase 2b clinical trial in Thyroid Eye Disease (TED) in 2023 and our Phase 2 clinical trial in cardiovascular disease in Q2 2024. We plan to initiate our Phase 3 clinical trial in TED later in 2024. More information about Tourmaline can be found at www.tourmalinebio.com.
General Responsibilities:
The Senior Analyst, Supply Chain, will be a member of Tourmaline’s Technical Operations team, reporting to the Senior Director, Supply Chain, and will work in close alignment with Clinical Operations, CMC, Regulatory, and Quality. The successful candidate will support all activities related to clinical demand forecasting, production planning, and coordinate both clinical and non-clinical shipments in support of overall supply logistics. This individual will ensure that patients in Tourmaline’s clinical trials are able to receive treatments when scheduled and that drug inventory is maintained at all clinical study sites domestically and internationally. The candidate should have strong organizational, communication, and team-building skills, and will have a proven ability to take initiative and manage multiple tasks in a fast-paced environment.
Responsibilities:
- Product use analysis and forecasting to determine the supply needs for global studies based on review of clinical trial protocols and discussions with Clinical Operations and Regulatory.
- Assist and support clinical supply labeling, packaging, and logistics in support of global Phase 2 and Phase 3 clinical trials.
- Assist in the creation and approval of label designs, content, and translations for investigational drugs used in clinical trials by soliciting appropriate cross-functional input from Clinical Operations, Regulatory and Quality.
- Participate in all relevant vendor meetings to discuss and maintain supply chain strategies, regulatory compliance, and partnership opportunities with the aim of optimizing clinical trial operations and ensuring timely delivery of investigational materials.
- Maintain and review action items to ensure timely completion of tasks, track progress, and facilitate communication among team members, fostering accountability and alignment with project objectives.
- Participate in the maintenance and monitoring of web-based clinical supply ordering systems for global supply management of placebo-controlled and open label clinical trials.
- Coordinate the collection and tracking of required documentation for clinical and non-clinical shipments such as import licenses, QP declarations and certifications, and pro-forma invoices.
- Provide oversight for import/export compliance and logistics vendor management supporting the clinical supply network.
- Monitor shipment and storage of investigational product for potential excursions or loss and disposition as appropriate.
- Maintain documentation in an audit ready state.
- Travel to vendors, internal team meetings, and clinical sites is anticipated to require up to 10-20% of the candidate’s time.
Education and Licensure:
- Bachelor’s degree is required.
- Additional degrees or certification a plus
Experience and Attributes:
- Minimum of 3 to 5 years relevant (e.g., clinical, pharmaceutics, clinical trial material) pharmaceutical/biotechnology experience in a Supply Chain Planning role.
- Excellent project management, organizational and communication skills. Project Management Professional certification is a plus.
- Experience working with contract packaging and labeling organizations, developing supply and demand models, and working with IRTs and regional depots with global IP distribution.
- Experience with distribution and recall processes for investigational products.
- Experience in cold-chain clinical supply distribution.
- General understanding of regulatory requirements for clinical supply distribution in North America, APAC, and EU including QP requirements.
- General understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
- Demonstrated ability to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
- A good team player with a solid record of collaboration within and across functional areas.
Base Salary Range:
$88,000 – $106,000 based on candidate professional experience level.
Note:
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.
