Associate Director, Pharmacometrics, Clinical Pharmacology Clinical Dynamix, Inc.
San Diego, CA9 days ago
Janux Therapeutics is seeking a Senior Director, Clinical Supply Chain will lead and execute Janux’s clinical supply strategy across Phase 1–3 programs, with a focus on enabling progression into late-stage development. This is a hands-on leadership role responsible for ensuring uninterrupted global supply of investigational medicinal product (IMP) while building scalable processes to support growing clinical program complexity.
This role partners closely with Clinical Operations, CMC, Quality, and Regulatory to align supply planning, manufacturing, and trial execution. The ideal candidate brings deep experience in biologics and global clinical trial supply, including hands-on support of late-stage clinical programs in a fast-paced biopharma environment.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Lead and develop clinical supply strategies across Phase 1–3 programs
- Ensure uninterrupted supply of IMP across global, multi-region clinical trials
- Lead the team in end-to-end clinical supply operations, including packaging, labeling, distribution, returns, reconciliation and destruction.
- Provide strategy and support in global logistics, including import/export activities and depot strategy, ensuring compliance with country-specific labeling and regulatory requirements
- Provide strategic leadership, cross-functional alignment, and operational oversight to ensure the successful execution of key activities across Clinical Operations, Quality, Regulatory, and CMC functions.
- Contribute to and review clinical trial documentation, including clinical protocols, pharmacy manuals, batch records, drug labels, and shipping documentation. Provide oversight of IRT strategy, setup, and execution
- Partner closely with CMC to align manufacturing schedules with clinical supply needs and scale-up activitiesOversee comparator sourcing and supply strategies as needed
- Select, manage, and oversee external vendors (CDMOs, depots, packaging and logistics providers), including RFPs, SOWs, and performance management
- Partner with QA on vendor qualification, audits, compliance activities, and the development and maintenance of supply chain-related SOPs and processes.
- Ensure compliance with GcPs, and global regulatory requirements
- Support inspection readiness and regulatory submissions related to clinical supply
- Develop and manage clinical supply budgets, forecasts, and spend tracking
- Provide regular updates to leadership on supply status, risks, and planning assumptions
- Lead, mentor, and develop a small clinical supply team and build scalable processes to support company growth
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
- Bachelor’s degree in life sciences, supply chain, or related field
- 12+ years of experience in biotech/pharma supply chain with 4+ years of people management experience within a clinical supply chain organization.
- Strong experience supporting Phase 2 and Phase 3 clinical trials
- Proven experience supporting global clinical trials (including EU, APAC, Canada), including multi-region labeling and distribution requirements
- Biologics experience required; oncology therapeutic area background strongly preferred
- Demonstrated ability to operate in a hands-on role within a small to mid-size biotech environment
- Strong expertise in clinical supply planning, forecasting, and inventory management
- Experience managing external vendors, including CDMOs, depots, and logistics providers
- Strong working knowledge of IRT systems and clinical supply infrastructure
- Solid understanding of GcP guidelines, 21 CFR and Annex 13 requirements
- Oncology experience strongly preferred
- Experience supporting transition from early-stage to late-stage clinical development
- Experience building or scaling clinical supply chain functions in an emerging biotech environment
- Strong leadership and people management skills, with the ability to mentor and develop team members
- Excellent cross-functional communication and stakeholder management skills
- Ability to operate effectively in a fast-paced, evolving environment and navigate ambiguity
- Strong problem-solving skills with a focus on practical execution
$257,000 - $275,000 a year
In addition to a competitive base salary ranging from $257,000 to $275,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.
Job Type: Full-time
Benefits:
· Annual bonus program
· Incentive stock option plan
· 401k plan with flat non-elective employer contribution
· Comprehensive medical insurance with 90-100% employer-paid premiums
· Dental and vision insurance
· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
· Unlimited PTO
· Generous holiday schedule; includes summer and winter company shutdown
· Relocation assistance
Schedule:
· Monday to Friday
Work authorization:
· United States (Required)
Additional Compensation:
· Annual targeted bonus %
Work Location:
· On site (San Diego, CA)
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies
The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.