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Biomarker Operations Manager

Employer
Janux Therapeutics
Location
San Diego, CA
Start date
Aug 6, 2022

View more

Discipline
Manufacturing & Production, Operations
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

Reporting into Janux Therapeutics’ Executive Director of Clinical Biomarkers, the Biomarker Operations Manager will play a pivotal role in bridging both translational science and operations through cross functional and external partnerships, strategic planning, and facilitating execution of key clinical biomarker execution discussions while contributing to a positive and collaborative team environment. The incumbent will manage the biospecimen lifecycle for Janux’ clinical stage programs; from clinical sample collection, analysis, to key data delivery.

This newly created position will require excellent attention to detail and strong organizational skills, coupled with aptitude and enthusiasm for collaboration and maintaining the integrity of complex clinical trial sample collections and records.

 

Responsibilities:

  • Assist in the development and lead the implementation of biomarker sample strategy within clinical programs in accordance with the requirements of quality, regulatory and ICH/GCP/GLP standards.
  • Provide scientific input, operational expertise, and technical oversight toward clinical biomarker design, implementation, and delivery of high-quality data.
  • Plan and coordinate all operational activities for the collection, handling, storage and delivery of biomarker samples and resulting data within clinical studies.
  • Contribute to the preparation of clinical documents such as clinical protocols, clinical study reports, lab manuals, ICFs, sample management plan, and site training materials.
  • Manage the development and oversight of the biomarker plans, analysis timelines, budgets, risk assessments, and quality metrics during study startup, conduct and closeout.
  • Contribute to central lab setup and management.
  • Establish and manage relationships with specialty vendors to ensure biomarker samples are processed, tested and data is reported to meet timelines and specifications.
  • As needed, manage relevant sample logistics and facilitate sample shipments and query resolutions among vendors or collaborator to ensure timely delivery.
  • Work with cross functional team members to identify an in-house LIMS/sample tracking system and lead implementation with associated supporting documents such as SOPs, Work Instructions, etc.
  • Identify areas of best practices and process improvements.
  • May perform other duties as required.

 

Required Skills/Qualifications:

  • Minimum of a BA/BS degree in life sciences or a related field.
  • 5+ years’ of relevant operational experience working within the CRO, biotech or pharmaceutical industry.
  • Industry experience must include the management of both peripheral blood and tumor biopsy samples and its corresponding activities on a range of complex multi-center clinical studies.
  • Knowledge of oncology drug development and/or biomarker development is preferred.
  • Experience with electronic databases/LIMS is required.
  • Detailed knowledge of the ethical, legal and logistical requirements of obtaining and processing human blood and tissue samples.
  • Strong understanding of ICH/GCP/GLP and other regulations is required.
  • Excellent oral and written communication skills are required, along with a solutions-based approach, flexibility, and the ability to focus and deliver on time-sensitive objectives.

 

Compensation:

In addition to a competitive compensation package with stock options and stock purchase plan, Janux also offers a comprehensive benefits package for our employees and their families, including medical, dental, vision, and supplemental disability insurance. Relocation assistance is also available.

Job Type: Full-time

 

Benefits:

  • 401K
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Supplemental disability insurance plans
  • Flexible schedule
  • Life insurance
  • Flexible vacation
  • Sick time
  • Incentive stock option plan
  • Relocation assistance

 

Schedule:

  • This position requires 24/7 response availability for emergency situations

 

Work authorization:

  • United States (Required)

 

Additional Compensation:

  • Annual targeted bonus %

 

Work Location:

  • Hybrid; San Diego, CA 92130

 

COVID-19 Vaccination required

Janux requires all new hires to be fully vaccinated for COVID-19 before the first date of employment.  As required by applicable law, Janux will consider requests for Reasonable Accommodations.

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

Since our inception in 2017, we’ve successfully built an innovative culture that encourages scientific creativity within the bounds of our data-driven decision-making philosophy. This enabled our agile R&D team to efficiently discover numerous novel preclinical candidates: each of our unpartnered pipeline assets was discovered in 2020.

We encourage energetic, scientifically driven professionals to review our open positions and apply to those that match their qualifications.

Company

At Janux, we are developing unique immunotherapies that have the potential to generate tumor-specific immune responses to attack and kill tumors without destroying a patient’s healthy tissue. We believe that combining Janux’s tumor-specific activation with multi-stage anti-tumor signaling will significantly improve safety, expand the therapeutic dosing window, and maximize patient responses.

Find Us
Website
Phone
858-750-4731
Location
11099 Torrey Pines Rd. Suite 290
La Jolla
CA
92037
United States
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