At Jaguar Health, we’re passionate about developing health solutions for humans and animals. Our culture is about providing everyone who works here with opportunities to exercise their responsibility, integrity, and creativity while growing themselves, their careers, and our business. The success of our vision depends on people who are bold, focused, innovative, passionate, and can work as a team. If this sounds like you then review the opportunities below to learn more about a career at Jaguar Health.
Jaguar is seeking to fill a full-time position within our Quality Assurance/Quality Control group. The Quality Assurance Manager will be responsible for maintaining superior quality standards while the company pursues development objectives in Animal Health.
This is a unique opportunity for an outstanding QA specialist to build a Quality Management System and integrate into key departments including Regulatory, Logistics, Legal, Marketing, and R&D.
The successful candidate will be self-motivated, work well in both independent and group settings, quickly adapt to changing situations and possess a willingness to learn.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Duties and Responsibilities
- Build a Quality Management System that establishes a set of guidelines for unifying company principles under one umbrella.
- Mange the efficient resolution of product inquiries
- Serve as the primary point person for all site visits by state and federal agencies.
- Manage the interaction with all external contract labs and manufacturing operations.
- Serve as the company safety advocate
- Manage compliance with all OSHA requirements.
- A. in chemistry or a related field
- Prior experience developing and implementing a Quality Management System.
- 5 to 7 years of experience in a Quality Assurance department managing contract facilities.
- Experience with process & product investigations, OOS issues, and stability studies.
- Experience with auditing contract lab and manufacturing organizations.
- Experience writing scientific documents for FDA submissions.
- CFR Part 210 & 211 (GMP guidelines for manufacturing drug substance and drug product for the Animal Health Industry)
- CMC section of FDA filing for Animal Health Product
- Microsoft 2007 suite of programs including, Word, Excel, PowerPoint, Outlook and Adobe
- Strong organizational, problem solving, and time-management skills
- Good oral and written communication skills in chemistry or a related field.
- Flexible and quick to learn new concepts
- Ability to follow Standard Operating Procedures
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Ability to multi-task and work in a fast paced environment
- Effectively organize, prioritize and follow-up on work assignments
- Maintain accurate records
- Professional and confidential
- Work independently and as a member of a team
- Establish and maintain effective working relationships
To perform the job successfully, an individual should demonstrate the following core competencies:
- Safety – Absolute commitment to safety for self and others.
- Values – Honors and demonstrates Company values.
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Interpersonal Skills – Maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others’ ideas and tries new things.
- Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; participates in meetings.
- Written Communication – Writes clearly and informatively; able to read and interpret written information.
- Teamwork – Balances team and individual responsibilities; exhibits objectivity and openness to others’ views; gives and welcomes feedback; contributes to building a positive team spirit; able to build morale and group commitments to goals and objectives.
- Quality Management – Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
Jaguar Animal Health is seeking an experienced regulatory affairs executive to lead the registration of its early-stage prescription product portfolios in the companion and equine animal sectors. The company is committed to identifying animal health market opportunities where it can develop species-specific products that leverage its broad intellectual property portfolio, deep pipeline and extensive botanical library. The successful candidate will drive all US and OUS regulatory initiatives at Jaguar, providing regulatory expertise, a strong network of animal health industry contacts, and proven success in the approval of new and innovative products for production animals and/or companion animals. Candidates must be skillful strategists and critical thinkers who are excited about the opportunity to serve as a C-level contributor at this innovative, emerging animal healthcare company. This hands-on position will be based out of Jaguar’s San Francisco headquarters and report to Jaguar’s CSO.
- Direct submission activities for a variety of veterinary pharmaceuticals.
- Compile and submit registration dossiers to FDA CVM in a timely manner with minimal supervision (and provide follow-up).
- Direct and manage interface/written communications on regulatory and technical matters with FDA CVM as well as regulator responses to submissions.
- Prepare and coordinate CMC areas of submissions to CVM; review manufacturing documentation and reports.
- Drive all OUS regulatory efforts in selected markets.
- Provide regulatory support to project teams and other departments at Jaguar.
- Maintain current knowledge of applicable regulatory requirements and guidelines.
- Manage label approval process for regulatory affairs with minimal supervision. Assure that product label claims are in compliance with all relevant laws and regulations.
- Prepare dossiers to obtain MUMS designation.
- 4+ years of experience in veterinary pharmaceutical regulatory role with demonstrated success in achieving regulatory approvals for veterinary pharmaceuticals.
- Experience should preferably include writing submission to FDA CVM and subsequently obtaining NADAs.
- A scientific degree in an appropriate biomedical subject (e.g. life sciences, biology, pharmacy, veterinary medicine, engineering).
- Experience working both independently and in multidisciplinary, geographically dispersed teams.
- Ability to prepare and present information to regulatory agencies and other scientific groups.
- Experience submitting documents to CVM electronically.
- Knowledge of European registration process a plus.
- Solid understanding of the manufacturing and testing of veterinary pharmaceuticals.
- Excellent organizational skills demonstrating ability to handle multiple projects concurrently
- Skilled at using the new electronic submission process of CVM.
- Detail-oriented and able to maintain accuracy in a fast-paced environment.
- Adept with MS Office suite, Adobe and other software.
- Excellent medical/technical writing and communication skills.
- Ability to learn quickly and adapt to change.
- Able to work collaboratively across functions as a member of the Jaguar team.
- Strong achievement and results orientation, with a “roll up your sleeves” attitude.
- Good communicator and listener who tests for understanding and is clear and concise.
- Resourceful, overcoming obstacles and achieving genuine results by bringing a creative approach to issues.
Other important parameters for this position:
- Compensation and benefits package includes attractive stock options component.
- Domestic and international travel will be required.
- Qualified candidate must be authorized to be employed in the United States.
Jaguar Animal Health is seeking a highly experienced Clinical Trial Manager to manage all aspects of studies, including management of clinical sites and CROs, for multiple trials related to gastrointestinal products for companion and production animals. The role will involve day-to-day collaboration with all members of Jaguar’s Clinical Operations team as well as with contract research organizations. This position will be based out of Jaguar’s San Francisco headquarters.
• Comprehensive oversight of operational aspects of assigned clinical trials.
• As applicable, manage Clinical Research Organization (CRO) interactions, including the development of RFPs, sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and project master files), interim and final data review of tables, listings and figures.
• Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• As applicable, work independently or with CRO to create study specific documents, such as data management plans, monitoring plans, etc.
• Facilitate protocol and final study report review amongst functional teams, internal and external.
• Support contract CRAs in the field; monitor data-cleaning progress.
• Monitor study progress: ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors including CRAs. Complete sponsor’s review of monitoring reports and periodic review of data quality. Identify potential study issues and recommend solutions or corrective actions as needed.
• Serve as a liaison and resource for investigational sites; review investigator contracts and site payments.
• Ensure transparent communication amongst team members and executive team members.
• Occasionally travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
• Organize and manage internal team meetings and other trial-specific meetings.
• Participate in the development, review and implementation of departmental SOPs and processes.
• Other job related duties as assigned.
• Minimum of 3 years’ experience as a Clinical Trial Manager (in the human or animal health world) or 4 years as a Sr. CRA or 4 years as a CRA II
• Prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance
• BS/BA degree in science or related field
• Prior animal health study management a plus
• Excellent oral and written communication skills
• Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
• Excellent organizational and the ability to re-prioritize tasks to meet changing timelines in a fast-paced environment
• Very detailed oriented
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
• In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
•Roll up your sleeve attitude
Other important parameters for this position:
• Compensation and benefits package includes attractive stock options component
• Candidates must be legally authorized to be employed in the United States. Jaguar does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position
• Relocation assistance is not being offered
Jaguar Animal Health has an immediate opening for experienced regional Clinical Research Associates to perform monitoring activities including overall management of clinical sites for multiple trials related to gastrointestinal products for companion and production animals. During the conduct of the study, the role will involve frequent collaboration with assigned study sites, members of Jaguar’s Clinical Operations team as well as with contract research organizations. This is a home-based position.
- Perform Site Qualification, Site Initiation, Interim Monitoring Visits and Close-out Procedures.
- Proficiently manage up to 10 regional sites.
- Monitor investigator performance and adherence to protocols.
- Address enrollment problems.
- Set up study centers and ensure each center has all required trial materials.
- Visit the study centers throughout the trial on a regular basis.
- Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment.
- Verify that the investigator followed the approved protocol and all GCP procedures.
- Perform site management including tracking of essential clinical trial documentation, training of site staff on study procedures, and monitoring of site adherence to protocol-specified procedures.
- Must use detailed knowledge of assigned protocol(s) and EDC training to ensure quality and deliverables are met across sites.
- Conduct initial review of adverse event reports for completeness prior to sending reports to regulatory groups.
- Monitor recruitment and data quality while on site and remotely through EDC systems and direct site communication.
- Communicate with central laboratories/vendors and internal study team on an ongoing basis to address and resolve issues.
- 6-8 years of clinical trial monitoring experience
- Experience monitoring veterinary clinical trials a plus, but not required.
- Demonstrated understanding of core veterinary terminology, medical records and clinical trial activities.
- Must have working knowledge of ICH-GCP guidelines and FDA regulations.
- Must be able to travel up to 45%.
- Proven ability to monitor and coordinate multi-site research trials.
- Excellent communication, interpersonal, decision making/problem solving and organizational skills.
- Attendance training and/or weekly update meetings either in person, via WebEx, or teleconference as required.
- Ability to work independently to initiate and implement appropriate quality control procedures.
- Proficiency with the MS Office suite and electronic data capture (EDC) systems.
Other important parameters for this position:
- This is a contracting role with hours that will vary
- Hourly rate to be commensurate with experience
- Relocation assistance is not being offered