Careers

Position: Lab Services Project Manager

Level: Manager

Dept: R&D

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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

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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

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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

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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

Position: Vice President, Drug Safety and Pharmacovigilance

Level: Executive

Dept: R&D

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Overview of Position:

The Vice President, Drug Safety and Pharmacovigilance position is responsible for determining the strategy for managing all operational processes and information systems supporting the global Drug Safety and Pharmacovigilance (PV) function within Equillium and coordinating such with its partners. Reporting to the Chief Medical Officer (CMO), this role will provide leadership to the PV & Drug Safety Team and woThis position will have a high degree of visibility and impact across the organization and oversees the management of the Equillium drug safety operations team and the Contract Research Organization who handle safety data from receipt to submissions, system operations, and quality management system. The VP also manages all DSPV operational compliance functions. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PV compliance.

Essential Duties & Responsibilities

Drug Safety Operations

• Determine data management strategy for the global safety database including the allocation of case processing tasks between Drug Safety operations and Contract Research Organization (CRO) staff
• Manage and direct Drug Safety operations staff to oversee case management functions ensuring process optimization, case quality, and accurate regulatory reporting.
• Work with external partner(s)to jointly manage cases, safety reporting and signal detection across global development for molecule candidates
• Optimize utilization of information systems supporting case management (e.g., Oracle Argus).
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Determine processes and/or tools supporting Pharmacovigilance signal management in accordance with GVP

Drug Safety Sciences

• Provide medical oversight of the PV and risk management functions at Equillium
• Direct signal detection activities based on regular and ad hoc reviews of aggregate safety data
• Coordinate safety governance within the company and ensure cross-functional involvement in the evaluation of potential emerging safety issues and any associated risk mitigation/management measures that are proposed
• Participate as a key stakeholder in safety analyses and ensure proactive and timely benefit-risk assessments of safety data involving Equillium products

Quality Management

• Ensure compliance of the PV system for all safety data sources in collaboration with Equillium cross functional stakeholders
• Identify procedures for monitoring compliance with drug safety-related policies, procedures, applicable regulations, and agreements with contractual partners
• Establish and measure key compliance, quality and performance indicators (KCI/KQI/KPIs) for the drug safety department
• Plan, conduct and document internal and external GVP audits to assess compliance with applicable regulations, regulatory commitments, company SOPs, protocols and contractual obligations as applicable
• Provide recommendations for corrective and preventive actions and tracking corrective action commitments until closure
• Manage the operational compliance for partnership, participate in and support audits of contractual partners as necessary
• Act as the representative in various Company-wide committees
• Oversight of Department Process and Project Management Efforts.
• Proactively identify procedural gaps and challenges and propose/implement solutions, lead the establishment of business process optimization efforts to ensure efficiency and process improvements with the department.
• Formulate controls to maintain a system of third-party vendors to ensure compliance with PV reporting requirements.
• Ensures meeting business objectives while adhering to agreed scope, time, quality and budget and oversee preparation of inspection readiness and manage/participate in the audits of business partners
• Develop operating plans and budgets and allocate resources to ensure budgets, schedules and performance requirements are met
• Model the Equillium Values including promoting collaboration at all levels of the organization

Supervisory Responsibilities

• Will supervise employee(s) directly and indirectly through matrix, direct reporting or in collaboration with external partners

Education:

• MD, or PharmD in related discipline and 10+ years of related experience, or equivalent

Experience:

• Equivalent combination of education and experience

Skills and Attributes:

• Demonstrated excellent organizational and planning capabilities – Excellent critical data analysis skills (clinical/systems/processes/compliance)
• Entrepreneurial, small/high-growth company experience is preferred
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Demonstrated excellent teamwork, collaboration and interpersonal skills – Demonstrated leadership skills including significant managerial experience, team motivation, collaborative interaction, ability to problem-solve, prioritize, take initiative, meet challenges
• Excellent communication skills (oral/written)
• In-depth knowledge of US and international pharmacovigilance regulations (e.g. EU PV Legislation), FDA requirements, international guidelines (ICH/CIOMS) with experience in their practical application
• In-depth understanding of pharmacovigilance processes, regulatory compliance and standardization
• Pharmacovigilance data systems (Oracle Argus, signal detection, and data analytics tools) experience is required
• Experience managing the DSPV process in development and post marketing, and with partnered products

Physical Demands / Travel:

• The physical demands of this job are consistent with light office duties.
• Travel Requirement- Domestic and/or international

Work Environment:

• The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
• To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.
• This position’s primary work environment is in an office / traveling in the field as indicated.

Position: Senior Director, Medical Affairs

Level: Director

Dept: R&D

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Senior Director, Medical Affairs

Position Overview:

The Senior Director, Medical Affairs serves as the scientific leader for the development and implementation of medical affairs strategic plans in support of  Research and Development objectives. The Senior Director works cross-functionally in a matrixed environment with internal colleagues and engages externally with key opinion leaders and stakeholders to support the strategic generation of scientific data and the consistent and accurate scientific communication of Equillium’s data globally.

Summary of Key Responsibilities:

• Leads Medical Affairs strategic planning and oversees implementation of activities in support of Research and Development objectives; key areas include medical/scientific communications, Key Opinion Leader engagement, collaborative evidence generation and scientific publications.
• Builds a cross-functionally aligned medical communications strategy in collaboration with Corporate Communications, Regulatory, Legal, Research, Clinical Development, Pharmacology and Compliance, etc., to ensure alignment of communication of key activities.
• Leads evidence generation activities (clinical and preclinical) including investigator sponsored research, collaborative research, strategic partnerships and expanded access programs.
• Establishes key opinion leader networks and steering committees to gather insights and support clinical trial enrollment in collaboration with Research and Development teams.
• Develops academic research center strategic engagement plans to identify and explore new collaborative research opportunities.
• Contributes to regulatory and business development activities; provides input into regulatory documents and participates in the evaluation of potential in-licensing candidates.
• Leads the development of global publication strategy and plans, in collaboration with cross-functional colleagues; drives the timely and scientifically accurate implementation of publication plans.
• Oversees the medical grant program, including establishing key objectives, managing incoming grant requests, coordinating review, and overseeing implementation.
• Leads Medical Information activities to address unsolicited requests for medical information, in the form of standard response documents, frequently asked questions, payer executive summaries, AMCP dossier, to health care professionals, payers and consumers.
• Plans and coordinates advisory board meetings.
• Ensure compliance with all industry best practices such as GPP3, ICMJE
• Establish Corporate publication policies and procedures.
• Establishes SOPs and sets standards to ensure that the Medical Affairs function operates effectively, efficiently and compliantly.

Qualifications:

• Doctorate degree required (MD, PhD or PharmD)
• Exceptional leadership experience with a minimum of 10 years of industry experience and a minimum of 8 years of Medical Affairs experience
• Experience leading and coordinating cross functional Medical Affairs activities and teams
• Strong statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately
• Awareness of regulatory landscape globally and provide appropriate guidance for the development of digital initiatives
• Strong knowledge of the transplant and immunology therapeutic area preferred
• Ability to travel up to 30% of time

Skills and Specifications:

• Excellent teamwork and collaboration skills
• Strong stakeholder and relationship management skills
• Demonstrated ability to think strategically and analyze issues and opportunities
• Excellent communication and negotiation skills
• Expert knowledge of scientific principles and concepts
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
• Effective process and project management skills