CAREERS

Position: Senior Clinical Operations Specialist

Position Level: Associate

Reports to: Senior Director, Clinical Operations

Dept: Clinical Operations

___________________________________________________________________________ 

Overview of Position:

Under minimal supervision in Clinical Operations, the Senior Clinical Operations Specialist will work with the team to coordinate the activities associated with the evaluation, initiation, management, maintenance, and close-out of clinical trials and study sites. May provide site and/or vendor oversight.

Essential Duties & Responsibilities:

• Track and maintain clinical trials documentation and information for study files on relevant platform(s) (i.e. SharePoint, Veeva).
• Coordinate the activities associated with site start-up and overall study management, including review of site documents in anticipation of site activation and site oversight through close-out
• Provide review and input on study-specific clinical plans
• May perform site feasibility assessment for new clinical protocols
• May identify clinical investigators
• Review and manage site regulatory documents to include collection of essential regulatory documents
• Coordinate the review and content of clinical study materials such as Investigator Site File templates, study guides and subject instructions
• May assist with coordination of site budgets and contracts
• May coordinate meetings, prepare and distribute meeting materials and meeting minutes
• May assist in contacting investigative sites to provide study-specific documents and other information
• May assist in clinical trial supplies management and distribution
• May assist in preparation of clinical study newsletters
• May assist with the review and oversight of data for quality (e.g. ensures that CRF data queries are resolved)
• Coordinate vendor tracking
• Build relationships and provides oversight on vendor performance
• Assist with program oversight, identifies deficiencies and risks, and assists with improvement and mitigation plans
• Ensure compliance with Equillium policies and procedures
• Review of monitoring reports. Identification and escalation of issues and assists with corrective action plans.
• Other duties as assigned

Job Requirements:

      Education: Bachelor of Arts (BA)/Bachelor of Science (BS) preferred

      Experience:

• 5 years related experience in life sciences or medically related field, including 4 years experience in industry within Clinical Development
• Experience with development of prospective site-selection criteria
• Experience reviewing essential documents for clinical trials
• Familiar with advanced concepts of clinical research
• Ability to deal with time demands, incomplete information or unexpected events
• Experience interactions with outside vendors (i.e. CROs, contract labs)
• Experience with reviewing adequacy of site-proposed ICs 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 communication and interpersonal skills
• Strong computer literacy, including: Microsoft Excel, Word, Outlook and PowerPoint
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
• Travel Requirement- 10% (Domestic)

Position: Staff Accountant

Position Level: TBD

Reports to: Vice President, Finance

Dept: Finance

___________________________________________________________________________ 

Overview of Position:

Reporting to the Vice President, Finance, the Staff Accountant is responsible for the duties primarily related to Accounts Payable, Payroll, Clinical Accruals, management of General Ledger accounts and consolidated financial reporting.

As such, the Vice President, Regulatory Affairs and 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:

• Provide oversight to AP Specialist and maintain accounts payable workflows and SOX internal controls
• Perform cash deposits, wire initiation and initiate ACH transactions, as necessary
• Oversight and maintenance of Expensify travel & expense system including both employee and credit card company expenses – responsibility includes preparing related journal entries
• Manage company’s bi-weekly payroll (Coastal) and related HR administrative functions – liaising with outside vendors/consultants where appropriate
• Prepare payroll and benefit monthly accounting entries
• Coordinate and process new hire paperwork including entering new employees into the payroll system
• Support all external audits – preparation of audit schedules
• Manage monthly close process including maintaining the monthly close checklist
• Prepare monthly journal entries
• Support monthly clinical accrual process with internal operational management
• Prepare monthly balance sheet reconciliations – for such areas including accruals, debt, cash and investments to ensure accurate reporting and ledger maintenance
• Support tax compliance (property, federal and state, Delaware franchise tax, annual tax provision, et al.)
• Support 401(k) compliance and 401(k)annual audit, if applicable
• Maintain Australian subsidiary books and related compliance requirements including financial statement consolidations and proper intercompany eliminations.

Job Requirements:

      Education: Bachelor of Science (BS) in Accounting. CPA preferred.

      Experience: Minimum 3 to 5 years experience. Public company experience a plus.

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 Excel, accounting software, and payroll software
• ERP experience required. QuickBooks experience a plus.
• Flexibility to adapt in a cross-functional and dynamic “start-up” environment

Position: Vice President/Senior Director, Business Development

Position Level: Vice President/Senior Director

Reports to: President & Chief Business Officer

Dept: G&A – Business Development

___________________________________________________________________________

Overview of Position:

As an integral member of the Business Development team, the Vice President/Senior Director, Business Development will assist in the identification and pursuit of strategic business opportunities including: mergers, acquisitions, partnerships, alliances, joint ventures, and licensing agreements that fit within the overall corporate strategy to further drive future innovation and growth. This position will play a key role in researching and profiling both companies and assets, as well as project managing and conducting due diligence.

Essential Duties & Responsibilities:

• Ability to initiate partnering process: search, evaluation and execution of in- and out-licensing agreements.
• Develops presentation materials for both internal and external opportunities.
• Assembles confidential and non-confidential presentations for potential partners.
• Manages an electronic data room for the purpose of due diligence.
• Liaises between external and internal parties for the triage of information requests in the course of due diligence and provides project management as required.
• Creates and maintains a detailed tracking tool to manage the status of interactions between companies and opportunities.
• Builds competitive intelligence tools.
• Works with the contracts department to prepare Confidentiality Agreements as needed.
• Extensive domestic and international travel expected.

Job Requirements:

       Education:  Advanced scientific or medical degree preferred.

       Experience: 10+ years of pharmaceutical industry experience with business development background.

Skills and Attributes:

• Keen business and scientific acumen.
• Solid understanding of the drug discovery, development and commercialization process.
• Ability to conduct scientific and clinical due diligence.
• Demonstrated ability to conduct market and business analysis in order to translate the result into effective communication tools (e.g., presentations).
• Ability to apply critical thinking and problem-solving techniques to make appropriate recommendations.
• Excellent verbal and written communication skills to transfer analysis, concepts and ideas into compelling communication, including the ability to simplify complex topics and condensed messages.
• Excellent presentation skills.
• Strong organizational and project management skills.
• Highly motivated, results driven self-starter, with proven ability to work in a rapid-paced environment.
• Team player with the ability to achieve team and company goals.
• Demonstrated ability to gather, organize and analyze large amounts of information quickly.
• Proven ability to manage multiple tasks and associated deadlines.
• Strong computer literacy, including Microsoft Office suite.
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment.

Equillium’s recruitment and employment process is managed by Human Resources and all candidates must be submitted through Human Resources. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or present candidates, but instead to contact Human Resources.

Human Resources will review and keep all resumes submitted on file.

Equillium is proud to be an Equal Opportunity Employer.

Position: Vice President, Regulatory Affairs and Quality

Position Level: Executive

Reports to: Chief Medical Officer

___________________________________________________________________________ 

Overview of Position:

Responsible for all Regulatory Affairs and Quality matters within Equillium, which includes: providing strategic and operational leadership in these areas, notably in the development and execution of regulatory strategy and through leading interactions with global regulatory agencies. Additionally, this position will also be responsible for developing, implementing and promoting Equillium’s overall GxP quality management system and all 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 total quality management throughout the organization.

As such, the Vice President, Regulatory Affairs and 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:

      Regulatory Affairs:

• Work closely with the executive leadership team, lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Equillium’s products and product-candidates.
• Develop and implement operational plans to achieve the board-approved regulatory objectives.
• Build a stage-appropriate regulatory affairs team, hire appropriate leadership, and manage internal and external consultant team members.
• Serve as primary regulatory agency contact (with the FDA and at other agencies) to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable and effective advocate for Equillium.
• Serve as key point of contact in relation to managing and directing regulatory inspections.
• Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Equillium products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
• Facilitate best strategy for clearance/approval of products in rest-of-world regions either by Equillium or by its partners/affiliates, and act as the senior regulatory contact for ongoing alliance management activities.
• Develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.
• Partner with and support clinical development, CMC, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
• Support the Pharmacovigilance and Safety functions as an active member of the Executive Safety Governance and Review team.
• Provide the business development team with guidance and critical evaluation of potential product opportunities, in support of strategic partnering and licensing activities.
• Provide regulatory review and approval of product labelling, promotional claims and advertising to ensure compliance with corporate policy, and US and international laws and regulations.
• Direct long- and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.

      Quality:

• Build a stage-appropriate quality team, hire appropriate leadership, and manage internal and external consultant team members.
• Manage and implement Quality systems. Manage and oversee SOPs, policies, training and vendors and vendor qualification processes. As appropriate, implement and maintain a suitable software system to support quality systems 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 the sponsor or contract organization, are conducted in compliance with applicable GCP requirements.
• Work with technical operations and manufacturing staff to ensure that clinical supply and commercial manufacturing activities are conducted in compliance with applicable GMP requirements.
• Be responsible for the overall review of batch records and release of clinical trial material lots and products, and the review of incident/deviation reports and of 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 Regulatory Affairs within the pharmaceutical industry with 7 years of specific leadership and management experience.
• Some oversight of and/or responsibility for Quality teams and activities across a range of GxP development functions.
• Experience leading the Regulatory Affairs and Quality functions, specifically the designing, writing, and submission of regulatory filings and correspondence within a similarly complex specialty/branded commercial pharmaceutical organization.
• Experience leading the submission process for both new entities and line extensions of existing products.

Skills and Attributes:

• Strong leadership competencies and strategic business perspectives required, to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and post-marketing activities.
• Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA and EMA.
• In-depth understanding of the drug development and life cycle management process
• Expertise in Quality and Compliance as well as experience in managing and preparing for regulatory inspections.
• Ideally, a history of active involvement with joint ventures, highly collaborative partnerships, and in/out-licensing of business opportunities.
• The 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, 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 project details.
• Ability and strong desire to work in a dynamic “start-up” environment and be able travel from time to time domestically and/or internationally.