Careers

Position: Clinical Research Associate

Level: Associate

Reports to: Clinical Operations

Dept: Development

___________________________________________________________________________

Overview of Position:
Under minimal supervision in Clinical Operations, works with the team to coordinate the activities associated with the evaluation, initiation and management of clinical trials and study sites. May assist in managing clinical studies including site and/or vendor oversight.

Essential Duties & Responsibilities:

• Assist with study site CDAs, feasibility, and selection
• Coordinates and assists with the activities associated with site start-up and overall study site management, including review of site documents in anticipation of site activation and site oversight through close-out
• Review and management of site documents
• Review, tracking and documentation of monitoring reports
• Identification and escalation of issues and assists with corrective action plans
• Provides review and input on study-specific plans
• Coordinates the review and content of study materials such as eCRFs, study guides and site/subject instructions
• Assists with the preparation, conduct and presentations for CRA Training
• May assist with coordination and management of study site budgets
• Manages the overall site investigational product accountability and reconciliation process
• Assists with the review and oversight of data (EDC and vendor data) for quality (e.g. ensures CRF data queries are resolved and data reconciles, i.e. AEs and Medical History to con meds)
• Coordinates CRO tracking, and training, including lab samples
• eTMF support and management; assurance of ongoing document maintenance and completion of study files, checking eTMF and assisting with loading documents and follow-up on missing items. Must be able to identify what documents should be posted in the eTMF per study status and manage to fulfillment.
• Builds CRO relationships and provides oversight on vendor performance
• Assists with program oversight, identifies deficiencies and risks, and assists with improvement and mitigation plans
• Ensures compliance with Equillium policies and procedures
• Intermittent clinical site monitoring for adherence to protocol and GCP
• May complete site visits in assistance of CRO and to promote timeline
• Review of clinical protocols and amendments, as needed
• Other duties as assigned

Job Requirements:

      Education:

• BA/BS in Biological Sciences or related field, or BSN/RN

      Experience:

• 5 years (2-3 years for CRA) related experience in life sciences or medically related field, including 4 years of
  experience in industry within Clinical Development (Sr. CRA)
• Experience with development of prospective site-selection criteria
• Protocol input experience
• Familiar with advanced concepts of clinical research
• Ability to deal with time demands, incomplete information or unexpected event
• Experience with interactions with outside vendors (i.e. sites, CROs, contract labs) and all functions of clinical
  research
• Experience with reviewing adequacy of site-proposed documents for compliance with relevant regulations

Skills and Attributes:

• Attention to detail
• Excellent time management and organizational skills
• Proven ability to manage multiple tasks and associated deadlines
• Exceptional and timely communication and interpersonal skills
• Strong computer literacy, including: SharePoint, Microsoft Excel, Word, Outlook and PowerPoint
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
• Travel required 10-50%, as needed

Position: Manager, Clinical Supply Chain

Level: Manager

Reports to: Vice President, Manufacturing Operations

Dept: Operations

___________________________________________________________________________

Overview of Position:
The Manager, Clinical Supply Chain will be responsible for managing investigational medicinal product (IMP) and clinical trial material for all Equillium clinical studies/programs. The Manager, Clinical Supply Chain will oversee all aspects of clinical supply management including packaging, labeling, monitoring inventory levels, distribution, destruction and overall reconciliation. There will be significant external interaction with contract service providers (CSP) and use of Interactive Response Technology (IRT) to track and ensure adequate supply of IMP at depots and clinical sites. This position will manage the IMP supply CSP and work with the selected IRT(s).

Summary of Key Responsibilities:

• Translate clinical study requirements into IMP demand forecast for individual clinical studies.
• Create and maintain overall (Company) IMP supply forecast.
• Manage all clinical supply activities including but not limited to: study monitoring and initial and resupply planning, packaging/distribution, completing clinical supply manager role in Interactive Response Technology (IRT) and assisting with IRT set-up, and managing distribution activities.
• Manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction and storage tasks for all clinical trial materials.
• Review and approve documentation related to packaging, labeling, distribution and destruction of clinical study materials. Maintain appropriate documentation in compliance with US and international regulations.
• Manage distribution and logistics for global clinical programs, including but not limited to clinical supply chain services, inventory control, import-export, and shipment of clinical supplies from third-party warehousing.
• Work with Clinical Operations, Manufacturing, Quality Assurance and Regulatory Affairs to maximize supply efficiency and develop risk mitigation plans.
• Work with clinical operations to configure and set up IRT, including automated randomization and drug supply management, design and UAT testing.
• Represent clinical supplies function at clinical study team meetings; ensure plans, timelines, and deliverable are communicated to internal and external customers.
• Work with cross-functional teams to develop specifications and complete user acceptance testing (UAT) of IRT systems provided by contract service vendors.
• Will review vendor and clinical study plans, such as, but not limited to: clinical supply processing and distribution protocols, pharmacy manual, IRT specifications and user manual
• Will review and respond to any temperature excursion or other IMP issues (CSP or site) and communicate such within a matrix environment.
• Will be responsible for ensuring clinical supply documentation is accurate and reflected in the electronic Trial Master Files.
• Ability to manage unblinded material/documentation and information to maintain the study blind.
• May provide input and/or draft supply SOPs.
• Other duties as assigned.

Qualifications:

• BS/BA degree
• Five years of related/relevant experience in a biopharmaceutical, CRO, or clinical supplies company
• Experience working with cross functional activities and teams
• Demonstrated experience with clinical supply management planning, forecasting. labeling, packaging, distribution, and reconciliation.
• Clinical Supply management experience using contract manufacturing companies.
• Experience with Interactive Response Technologies (IRT).
• Working knowledge of GMP/GCP/GLP regulations.
• Excellent communication, organization, computer (MS Office, Outlook, Excel, databases, Zoom) and project management skills.
• Ability to travel up to 10% of time

Skills and Specifications:

• Attention to detail is a must
• Excellent teamwork and collaboration skills
• Strong stakeholder and relationship management skills
• Demonstrated ability to think strategically and analyze issues and opportunities
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
• Effective process and project management skills
• Ability to manage multiple studies, large volumes of data and deadlines simultaneously
• Ability to work in a fast paced environment

Position: Senior Director/Head of Quality

Position Level: Senior Director

Reports to: VP Regulatory

___________________________________________________________________________

Overview of Position:
Responsible for the Quality Management System for Equillium, including: providing strategic and operational leadership for all quality related activities, as well as developing, implementing and promoting Equillium’s quality program for GCP, GMP and GLP activities. The incumbent will develop, implement, prioritize, and communicate the company’s quality strategy and its quality programs, including quality assurance and quality management throughout the organization.

As such, the Senior Director/Head of Quality plays a key role in enabling Equillium to achieve its business objectives, both in respect of existing products and in the identification, assessment, acquisition and development of new products.

Essential Duties & Responsibilities:

Quality

• Build a stage-appropriate quality team, hire appropriate personnel, and manage consultant team members.
• Manage and implement Quality systems. Manage and oversee SOPs, policies, training and vendors and vendor qualification processes. As appropriate, select, implement, and maintain a suitable software system to support quality related activities.
• Conduct ongoing review of quality and assessment metrics, including development of mitigation strategies as needed and communicate quality metrics to senior leadership on a regular basis.
• Work with clinical development, drug safety and regulatory affairs staff to ensure that all activities, whether performed by Equillium or contract organizations, are conducted in compliance with applicable GCP requirements.
• Work with technical operations and manufacturing staff to ensure that clinical supply and planned commercial manufacturing activities are conducted in compliance with applicable GMP requirements.
• Be responsible for the review of batch records and release of clinical trial material lots and products, and the review of incident/deviation reports and change controls related to manufacturing/quality processes.
• Develop, implement and monitor compliance with quality agreements established with vendors and partners.
• Ensure that the company and all company sites, vendors and clinical trial sites are prepared, for inspection by regulatory authorities.
• Provide post-regulatory agency inspection support and follow-up as required.
• Perform or oversee internal and external audits, ensuring compliance with company policies, procedures and applicable regulations.
• Review and approve audit reports and Corrective and Preventive Actions (CAPAs).
• Report compliance-assessment metrics and updates to senior clinical, regulatory, and quality-management personnel.
• Promote the company’s quality programs to its customers and employees.
• Develop and implement employee communication and training programs in connection with quality objectives, strategies and processes.

Job Requirements:

      Education:

• An advanced scientific degree
• RAPS / RAC desirable

      Experience:

• 15+ years experience leading oversight of and/or responsibility for Quality teams and activities across a range of GxP development functions within the biotech/pharmaceutical industry for both drugs and biologics with 7 years of specific leadership and management experience.
• Experience designing and implementing quality systems, including development of policies and procedures, work instructions, auditing, change management and quality training.

Skills and Attributes:

• Expertise in Quality and Compliance, including preparations for BLA and NDA submissions, manufacturing and batch release and commercialization
• Demonstrated experience preparing for and hosting GxP quality audits, regulatory inspections, etc.
• Strong leadership competencies and strategic business perspectives required, to ensure that compliance practices are fully integrated throughout all clinical studies, clinical development and post-marketing activities
• In-depth understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA and EMA
• Effective leader – able to work across all levels of the organization, including coaching and mentoring employees, directing consultants and communicating regularly with executives
• Thorough understanding of the manufacturing batch review and release process (GMPs), especially in the contract manufacturing organization setting
• Able to design and execute vendor audits, as well as internal audits
• Ideally, a history of active involvement with joint ventures, highly collaborative partnerships, and in/out-licensing of business opportunities.
• Ability to assimilate and interpret trends in the US healthcare policy environment that directly affect business decisions in the pharmaceutical/biotech industry
• Proven interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross functionally with multiple corporate sites, partners, vendors, teams and personalities.
• Excellent oral and written communications skills.
• Commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
• An entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, attitude and approach
• The ability to think strategically as well as execute tactically
• Ability and strong desire to work in a dynamic “start-up” environment and be able travel from time to time domestically and/or internationally

Position: Senior Director, Clinical Operations

Level: Senior Director

Dept: Development

___________________________________________________________________________ 

Senior Director, Clinical Operations

Position Overview:

The Senior Director, Clinical Operations is key leadership position responsible for the global execution of clinical trials. The position will report to the Vice President of Development Operations. The Senior Director Clinical Operations must have a mastery of FDA regulations and ICH guidelines relating to industry sponsored clinical research to lead an internal team and/ engage and manage vendors.

Essential Duties & Responsibilities:

• Works closely with the internal stakeholders to finalize clinical protocols and generate study timelines and study budgets. Manages timelines and budgets for the clinical trials.
• Plans and manages internal and external logistics and all activities/services required for the execution of clinical trials.
• Initiates, cultivates, and maintain strong relationships with investigators, site staff, and vendors.
• Development of the Clinical Operations team and providing leadership, guidance, and oversight.
• Works closely with finance, regulatory affairs, project management, drug safety, biometrics, manufacturing and legal to develop corporate, program and vendor budgets, agreements, scopes of work, study strategies and standard operation procedures (SOP’s).
• Evaluates and manages contract research organizations, contractors, specialty laboratories and other vendors and internal support staff.
• Pro-active in identifying issues internally, with vendors and/or at clinical sites that could interfere with achievement of project goals and timelines.
• Management of risk at the program level and provision of justification for risk mitigation and contingency plans; lead implementation of accepted plans.
• Develop clinical project staff to meet current and future business needs by ensuring the staff is adequately trained and issues within clinical programs are escalated effectively.

Job Requirements:

Education: BA/BS in science-related field

Experience: 15+ years biopharma industry experience including 7+ years of relevant work experience in a clinical operations management role.

Skills and Attributes:

• Attention to detail
• Excellent time management and organizational skills
• Proven ability to manage multiple tasks and associated deadlines
• Exceptional communication and interpersonal skills
• Strong computer literacy, including Microsoft Office suite
• Strong project management tools/process experience (e.g. management integration, scope, timeline, cost quality, resources, communications, risks and procurement)
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment Extensive experience in successfully managing the operations of domestic and international clinical trials.
• Understanding of the requirements and company/regulatory needs concerning project documentation.
• Demonstrated success in the conduct of multinational clinical trials and management of multiple service providers.
• Strong skills and experience with budget development, negotiation, forecasting, and finance.
• Strong line-management skills, resource management skills, aptitude for public speaking and training of both in-house and site personnel is essential.
• Experience managing remote employees.
• Significant (domestic and international) travel may be required.

Position: Research Intern

Dept: Research

Level: Intern

___________________________________________________________________________

Overview of Position:
Equillium is looking for a long-term Research Intern (RI) to join our research team. This position will be an integral part of our research team working on advancing our understanding of the CD6-ALCAM pathway. The candidate will be a motivated individual with an interest in science and would like to gain experience working in an immunology research lab. Through guided mentorship, the RI will be responsible for providing services and administrative support for Equillium’s lab space located at the Center for Novel Therapeutics (CNT). The successful candidate will also learn how to perform a variety of molecular biology and immunology research techniques and work on assignments of moderate complexity which includes performing experiments, making detailed observations, analyzing data, and interpreting results. May be asked to perform other scientifically-related duties as needed.

Essential Duties & Responsibilities:

• Assist with upkeep of a small laboratory by maintaining inventory, placing orders, restocking supplies, and organizing documents for financial review
• With proper training, assist with daily lab maintenance including:
  • Cleaning & sanitizing equipment when needed
  • Managing proper disposal of biohazardous waste
  • Receiving and distributing packages from the loading dock
• Attend internal scientific research meetings when schedule allows for
• With sufficient experience, will progress to designing and executing small-scale experiments

Job Requirements:

      Education:

• High school diploma or equivalent education

      Experience:

• 0-6 months of relevant experience in a biology focused laboratory, such as a semester long undergraduate research project or a temporary assignment in industry
• Some laboratory experience in biology, chemical biology, or related discipline (relevant courses may be considered for laboratory experience)
• Mechanical aptitude with operating laboratory equipment, basic maintenance, and calibration with minimal supervision
• High motivation and independence in reading scientific literature and performing experiments under minimal supervision

Skills and Attributes:

• Highly self-motivated
• Detail-oriented with excellent time management and organizational skills
• Exceptional communication and interpersonal skills
• Strong computer literacy, including Microsoft Office suite
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment.

Position: Assoc. Director/Director Clinical Data Management

Level: Management

Dept: Clinical Operations

___________________________________________________________________________

Overview of Position:

The Position The Clinical Data Management (CDM) department plays an integral role as part of the cross-functional study team. CDM are responsible for the collection, organization, and integrity of data collected as part of our clinical trials and other sample accrual programs. The Associate Director/Director, CDM, will oversee data management activities across multiple studies and compounds from study start-up through study closure in support of clinical trial objectives and corporate goals. You will play a key role in ensuring complete, accurate, high quality clinical data for outsourced trials.

Essential Duties & Responsibilities:

• Oversee clinical data management (CDM) activities across multiple studies and compound
• Represent CDM in cross-functional meetings
• Ensure DM project deliverables are completed on time and in accordance with quality standards and requirements from study start-up through study closure/archival
• Apply effective vendor management throughout the study
• Responsible for ensuring complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans
• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable
• Ensure accurate development and execution of data integrations between EDC, IXRS and/or external vendor data sources
• Responsible for management of data transfers for assigned studies, including review of test data transfers for consistency with data transfer agreements
• Participate in the RFP process including the evaluation of potential vendors
• Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
• Perform supplemental data reviews according to the data quality checks outlined in the data quality review plan
• Participate in reviews of blinded TFL output prior to final database locks
• Report query trends and data/query/SDV metrics to the Study Management Team (SMT)
• Participate in the development of EDC custom report specifications or SAS Clinical Programming report specifications as needed
• Participate in the development and/or enhancement of CDM department standards, operational procedures and best practices
• Assist with strategic planning activities for the CDM department and participate in the implementation of new departmental

Job Requirements:

Education:

Bachelor’s degree with at least ten (10) years of relevant industry experience

Experience:

• Demonstrated project management experience and be able to perform under tight timelines and balance conflicting priorities
• Experience working with and managing CROs
• Experience with writing SOPs, Work Instructions, Data Management Plans and Guidelines
• Experience with SAS or SQL programming techniques with clinical data management application a plus
• Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices

Skills and Attributes:

• Attention to detail
• Ability to work effectively in both a team setting and independently
• Proficient in Medidata Rave
• Comfortable working in a highly regulated environment and have an understanding of relevant regulatory requirements
• Exposure to other EDC platforms is a plus
• Excellent time management and organizational skills
• Proven ability to manage multiple tasks and associated deadlines
• Exceptional communication and interpersonal skills
• Strong computer literacy, including Microsoft Office suite
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment Extensive experience in successfully managing the operations of domestic and international clinical trials
• • Travel Requirement- Domestic and/or international

Position: Manager, Trial Master File (TMF) Operations

Level: Manager

Dept: Clinical Operations

Reports to: Clinical Operations

___________________________________________________________________________

Overview of Position:

This position will provide subject matter expertise and Clinical Operations Team support required to ensure that study Electronic Trial Master File (eTMF) documents are audit and inspection ready. Ensure the eTMF is managed in accordance with relevant regulations, ICH-GCP guidelines and Equillium SOPs. Contributes to the development of SOPs, Work Instructions (WIs) and other tools to ensure compliance with applicable regulations and records retention policies and practices. Train Clinical Trial Associates (CTAs) and other team members on eTMF systems and processes. Work cross-functionally with internal departments and external resources, such as CROs, to resolve gaps and quality issues in the eTMF.

Essential Duties & Responsibilities:

• Act as the main-point-of-contact at Equillium for assigned study eTMFs
• Serve as subject matter expert on domestic/international documentation requirements
• Maintenance and management of overall eTMF operations including metadata specifications, filing and QC of all study documents per DIA reference model structure from set-up to archival.
• Assist in developing eTMF-related SOPs, forms, and plans as needed, to ensure compliance with ICH E6(R2).
• Lead development and finalization of TMF plans.
• Ensure document quality and compliance through active engagement with clinical study teams, Equillium personnel and study vendor teams
• Identify opportunities for continuous process improvement; recommend solutions and implement as needed.
• May contribute to the specification, configuration, migration, UAT and implementation of the eTMF solution (Veeva Vault)
• Evaluate study requirements (essential document list); ensure appropriate eTMF structure is developed prior to start-up based on type of study designed (blinded vs unblinded, etc)
• Support training of Equillium and vendor team personnel on the eTMF solution and relevant SOPs
• Ensure Equillium and vendor team personnel are appropriately assigned eTMF user roles and permissions
• Ensure study eTMFs are maintained with an audit-ready strategy
• Create and distribute eTMF trending metrics and status updates to Equillium Clinical Operations and CRAs for CRO / Vendor follow-up and resolution
• Ensure identified discrepancies noted in status reports are addressed and resolved within timelines designated in TMF plan
• Coordinate interim, and close-out eTMF QCs with Clinical Operations
• Participate in audits and/or inspections of Clinical Operations and the eTMF
• Ensure Clinical privacy and security standards are met and adhered to.
• Assist in routine internal and external master file audits to ensure compliance with applicable Standard Operating Procedures (SOPs), Policy & Procedures, US Food and Drug Administration (FDA) and International Council for Harmonization (ICH) Good Clinical Practices (GCP) guidelines.
• May supervise other eTMF specialists
• Perform other tasks and assignments as needed

Job Requirements:

• Associates/Bachelor’s degree in a relevant discipline preferred
• 5 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment in roles focused on clinical trial documentation
• Proficiency with eTMF technology including prior, demonstrated experience managing eTMF systems and/or service providers is required
• Experience with Veeva Vault eTMF software is required
• Experience with the Drug Information Association (DIA) Trial Master File Reference model (3.2 preferred) and a demonstrated understanding of records management best practices
• Demonstrated understanding of the clinical drug development process and clinical trial methodology
• Demonstrated current knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical documentation
• Demonstrated ability to assess current and future business needs to ensure the clinical documentation function is strategically and operationally positioned to properly support the Clinical Operations, Clinical Development, Biometrics, Regulatory Affairs and QA
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Able to attend off-site meetings/training/conferences as needed
• Knowledge of ICH-GCP guidelines in relation to TMFs
• Technology to be used: Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, Outlook e-mail, Teams), Zoom, Adobe Acrobat, Veeva Vault eTMF, cell phone and printer/copier/scanner.

Skills and Attributes:

• Demonstrated ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.
• Demonstrated ability to discuss strategic and sensitive issues.
• Ability to work well with people and establish effective relationships across all levels of the organization.
• Requires task orientation for projects but has a good understanding of how the task meets the deliverable objective.
• Able to identify improvements in the process to meet the objective and/or recommend alternative tasks that meet objective.
• Achieves quality and timeliness of objectives.
• Ability to format and publish large documents and create and maintain tracking systems and spreadsheets.
• Ability to coordinate review and finalization of documents with multiple stakeholders.
• Aptitude to learn additional software programs and databases quickly.
• Ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner.
• Ability to work effectively under pressure of deadlines.
• Demonstrated ability to make decisions involving conflicts of interest.
• Expected travel time is less than 10% for this position.

Position: Lab Services Project Manager

Level: Manager

Dept: R&D

___________________________________________________________________________

Position Overview:

The Lab Services Project Manager is the key point of contact and liaison between external laboratories, clinical operations, clinical pharmacology and research.  The Lab Services Project Manager is responsible for performing activities related to the tracking, inventory, storage, sample processing, results and transport of biological samples for clinical studies and research.  This position is responsible for ensuring and maintaining lab vendor operational excellence in quality, service level, and compliance.

Summary of Key Responsibilities:

• Primary contact for external laboratories and internal stakeholders as related to managing biological samples.
• Coordinates and monitors sample shipments from clinical sites to central laboratories and ancillary labs.
• Leads the development of CSP (contract service provider) Laboratory specification documents, site manual(s) and training documents.
• Monitors and manages external laboratory performance metrics.
• Ensures shipping documentation and packaging requirements are met.
• Tracks and monitors sample shipments.
• Manages kit production at laboratories on behalf of Equillium and any back-up kit building needs to be completed by Equillium.
• Tracks inventory of collection kits (e.g. tubes, labels, requisitions, expiry) and assists with inventory at clinical study sites and any specialty tube requirements at the CSP.
• Maintains sample inventory in Excel /tracking software.
• Manages stored samples per consenting timelines.
• Manages sample discrepancies as necessary, with support from clinical operations and/or research.
• Ensures compliance with transportation regulations including any required import/export licenses or other permits.
• Supports the evaluation of novel technologies and techniques for their suitability for analysing clinical samples.
• Responsible for building and maintaining positive laboratory relationships

• Resolves resource allocation issues, conflicts, and priorities across vendors, team and timelines to ensure projects are staffed appropriately, completed on time, and within budget constraints.
• Manages cost of contracted laboratory work.
• Tracks progress and proactively communicates the impact of changes.
• May manage flow of data between external laboratories, CROs, and Equillium.
• Completes, files, and archives all relevant study documentation according to the applicable SOPs and plans.
• Liaises with couriers,  local and/or global shippers as appropriate.
• Ensures clear communication between Equillium, CRO, and laboratories

Qualifications:

• BA/BS (prefer in Biological Science or related field)
• 3+  years of relevant related experience in a biopharma company, CRO, or laboratory

Skills and Specifications:

• Attention to detail
• Excellent time management and organizational skills
• Excellent teamwork and collaboration skills
• Effective process and project management skills
• Exceptional communication and interpersonal skills
• Ability to work in a fast paced, matrix team environment
• Strong computer literacy, including Microsoft Office Suite
• Ability to travel up to 10% of time

Position: Vice President, Biometrics

Level: Vice President

Dept: Development Operations

___________________________________________________________________________ 

Overview of Position:

Responsible for the overall management and development of the department of biostatistics and clinical data management. The statistical leader for the company in terms of execution, strategy, and regulatory interactions. This position may be the lead statistician on individual projects.

Essential Duties & Responsibilities:

• Ensures overall effective operations in biostatistics, clinical data management, and clinical/statistical programming
• Interacts with executive leadership to establish a vision for the Department
• Ensures projects are appropriately resourced (with employees and/or consultants)
• Works with Clinical Development to design, conduct, and analyze clinical studies
• Lead author (or approver) of statistical analysis plans
• Approves appropriate statistical and data-presentation methods for publications and regulatory interactions
• Develops productive relationships with clinical development, clinical operations, regulatory, drug safety, research, and other functional groups
• Provides executive leadership for CRO activities, manages relationships, escalation, and resolution of issues
• Acts as the lead statistician for individual clinical studies
• Participates in due diligence reviews with Business Development for partnering, in licensing, and out-licensing
• Interacts with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to negotiate and ensure ongoing agreement
• Leads and manages the development and implementation of best practices, innovative study designs, and SOPs for clinical data management, biostatistics, and statistical programming
• Responsible for evaluating and managing biostatistics, data management, and statistical/clinical programming CROs (or those functions at full-service CROs
• Directly supervises employees and consultants
• Leads the development and implementation of strategies consistent with the Company’s strategic objectives

Job Requirements:

      Education:

• Ph.D. (preferred), Masters required

      Experience:

• Fifteen (15) years of related experience in life sciences or medically related field
• Ten (10) years in the biopharma industry
• Seven (7) years of departmental management
• Expert in advanced concepts of clinical research and clinical study design
• Expert understanding of the biostatistics, clinical data management, and clinical/statistical programming functional areas
• Proven implementation of successful management of statistical and data aspects of clinical studies in support of regulatory filings and marketing applications
• Significant experience with the FDA and other international regulatory authorities

Skills and Attributes:

• Attention to detail, business, and financial acumen
• Excellent time management and organizational skills
• Proven ability to manage multiple tasks and associated deadlines
• Exceptional communication and interpersonal skills
• Strong computer literacy, including statistical programs, Microsoft Excel, Word, Outlook, and PowerPoint
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment

Travel Requirement:

• Approximately 10% (Domestic & International) for regulatory interactions and advisory board

Position: Director, Regulatory Affairs

Level: Mid-Level

Dept: Regulatory

___________________________________________________________________________ 

Overview of Position:

The Regulatory Affairs Director serves as the Regulatory Lead for development projects while managing, reviewing, planning and preparing complex regulatory submission documents for global regulatory filings. Among other responsibilities, the Director will interpret regulations, and provide regulatory guidance to project teams. The Director drives regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives as well as provides regulatory affairs perspective to project teams and other functions. Lastly, the Director supports management with development and implementation of departmental strategies and policies.

Essential Duties & Responsibilities:

• Represent regulatory in cross-functional teams and provide functional teams with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration.
• Develop and execute regulatory strategies to ensure (nonclinical, clinical, CMC) development plans are comprehensive and comply with regulatory requirements for marketing applications.
• Coordinate the preparation, review and execution of regulatory submissions (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).
• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
• Effectively plan, organize, and conduct formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
• Maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on the development programs.
• Interact and manage external vendors and proactively resolve issues related to outsourced regulatory activities.
• Responsible for communication of submissions and approvals to relevant cross functional teams.
• Ensure archiving of regulatory documents (eg, submissions, internal memos, key correspondence).
• Plan, develop and write Standard Operating Procedures (SOP) to support the Regulatory Department activities. Interact with Company personnel to implement SOPs.
• Provide input into critical metrics and management reports.
• Proactively seeks out and recommends process improvements.
• Other regulatory activities as assigned.

Job Requirements:

      Education and Experience:

• Bachelor’s degree in scientific discipline is required. A Master’s degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable.
• 10 years of regulatory experience; OR a Master’s degree, or JD with a minimum of 7 years of regulatory experience in regulatory strategy development.
• Managing and coordinating regulatory submissions (IND, NDA/BLA, amendments, supplements, annual reports, etc).
• Preparation and coordination of CTA submissions.
• Experience in biologics is a plus.

Skills and Attributes:

• Ability to understand scientific and health principles related to product development and regulations.
• Attention to detail.
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment.
• Experience in successfully managing the operations of domestic and international clinical trials.
• Proven ability to manage multiple tasks and associated deadlines.
• Exceptional communication (oral and written) and interpersonal skills.
• Strong computer literacy, including Microsoft Office suite.
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment.

Position: Scientist

Dept: Research

___________________________________________________________________________

Overview of Position:

The Scientist will be an integral part of our research team working on pre-clinical development programs with a focus on immune cell biology in response to targeted therapeutics. The individual will provide technical and scientific expertise in efforts to understand drug dependent immune responses. The successful incumbent will have extensive hands on experience with standard immunological and biology techniques (Flow cytometry, ELISA-based techniques, primary immune cell culture, T cell activation, etc.). The Scientist will be responsible for internal research efforts related to pre-clinical and characterization.

This position is hands-on and requires the effective communication and documentation of results. Ideal applicants will be able to work both independently and collaboratively, self-motivated, possess excellent communication and organizational skills, and carry a strong commitment to excellence.

Essential Duties & Responsibilities:

Internal Scientific Duties

• Performs a variety of laboratory procedures, including cell-based and biochemical assays, using both new and established methods and techniques
• Conducts experiments and data analyses, and interprets results
• Assist in upkeep of a small laboratory
• Design experiments to address both mechanistic and disease-based questions and hypotheses
• Organize and maintain data files and reports
• Conduct literature reviews and attend seminars to keep up-to-date on topics relevant to research at Equillium
• Communicate results at research and cross-functional meetings 

External Scientific  Duties

• Provide input on study designs to be performed with external CROs and academic collaborations

Job Requirements:

      Education:

• PhD and 1-3+ years postdoctoral training in immunology or a related field

      Experience:

• Proven ability to make important contributions in immunology or related fields
• Current knowledge of research, drug discovery and development, with emphasis on immune cell activation, checkpoint, and exhaustion pathways
• Proven track record of success demonstrated by training from top research universities with first author papers in high impact journals and presentations at scientific conferences
• Knowledge of the molecular pathways involved in the activation of the innate and/or adaptive immune response
• Proficiency in the culture of human primary immune cells (mainly T cells and PBMCs)
• Proven experience with immune cell activation
• Experience with multi-color flow cytometry, molecular biology techniques (PCR, cloning etc.)
• Experience with both ELISA-based assays and multiplex cytokine assays (Luminex, MSD and/or CBA
• Excellent oral and written communication skills
• Be an effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines

Skills and Attributes:

• Design, conduct, interpret, and report laboratory experiments on a daily basis
• Interpretation, presentation, and detailed documentation of experiments within a lab notebook as well as preparation of reports
• Help manage internal laboratory activities under tight timelines
• Develop and follow standard operating procedures
• Conduct multiple research activities in parallel
• Help identify and prioritize high impact research activities
• Keep up with published literature directly relevant to the Equillium programs
• Must have strong communication skills as evidenced in public presentations and/or peer reviewed literature
• Must have effective troubleshooting and problem-solving skills
• Success in this role requires high attention to detail with the ability to multi-task
• Must be an effective team player, strong individual contributor, self-motivated, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines
• Highly organized and diligent about documentation is required and cannot be overstated