CAREERS

Position: Manager, Clinical Trials

Position Level: Manager

Reports to: Sr. Director, Clinical Operations

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Overview of Position:

Managing and meeting the objectives of clinical studies and programs by ensuring successful conduct of assigned clinical programs consistent with applicable regulations, Good Clinical Practice (GCP) and current standard operating procedures (SOPs).  Accountable for meeting clinical study and milestones within scope and budget.  Interface effectively with various clinical service providers.  Establish working practices that promote and maintain a culture of inspection readiness at all times.  Lead and provide oversight of operations activities of project(s) and/or program(s).

Essential Duties & Responsibilities:

Clinical Operations and Clinical Study Project Management:

• Lead clinical operations activities in the preparation and coordination of clinical trial set-up, maintenance and closure in accordance with GCP and SOPs.
• Provide study management by interfacing with representatives from key functional groups such as: Clinical Development, Data Management, Statistics, Regulatory Affairs, QA, Medical Writing, CMC, and Research
• Actively support other functional groups with clinical trial set-up, maintenance and closure (e.g. data management, statistics, medical writing, clinical trial material vendors, etc.)
• Provide expertise and direction on the activities involved with planning, conducting and reporting of clinical data.
• Lead trial initiation activities including protocol development, activities for investigator site selection and regulatory preparedness, investigator budget and contract negotiation, and clinical vendor procurement activities.
• Ensure overall study progress including development and maintenance of timelines, risk mitigation and contingency plans for all aspects of trial conduct, and management of study scope and change control.
• Actively engage in study oversight to monitor adherence to GCP with timely and appropriate escalation of issues as necessary.
• Participate in the development and review of regulatory documents as appropriate.
• Conduct site clinical site monitoring activities as needed.
• Other duties as assigned.

Vendor Management:

• Meet with and gather information on new vendors to build a knowledge base and maintain understanding of available services.
• Complete vendor proposal requests in conjunction with the contracts and outsourcing team as required and actively participate in the review and selection process of clinical vendors.
• Ensure adherence to business processes with respect to vendor contracts and invoicing procedures.
• Serve as key liaison with project and site management clinical research organizations (CROs) and monitor and track adherence to contracts and budgets.
• Participate in quarterly trial budget reviews and invoice reconciliation.

Quality and Process Improvement:

• Participate in development and review of clinical SOPs.
• Maintain 100% compliance with SOP training.
• Conduct audits and inspection readiness visits to investigator sites and vendors
• Promote and lead process improvement initiatives consistent with GCP operations and project management tools and concepts.

Job Requirements:

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

       Experience:

• 5-8 years related experience in life sciences or medically related field, including 3 years of experience in industry within Clinical Operations (i.e. Manager level)
• Experience with development of prospective site-selection criteria
• Practical experience in initiating, maintaining and terminating clinical trials.
• Previous experience in leading cross-functional teams.
• Protocol development experience
• Familiar with advanced concepts of clinical research
• Ability to deal with time demands, incomplete information or unexpected events
• Experience with management of CROs or other vendor relationships.
• Experience with administration of budgets and grants
• Experience with reviewing adequacy of site-proposed documents for compliance with relevant regulations
• Experience managing Clinical Research Associates
• Previously conducted or managed trials in autoimmune and inflammatory conditions desired.

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: Microsoft Excel, Word, Outlook and PowerPoint
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
• Travel required 20-30%

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, Clinical Development

Position Level: Executive

Reports to: Chief Medical Officer

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Overview of Position:

The primary objective of this position will be to serve as the lead for clinical research activities within Clinical Development. This position will be responsible for directing and leading cross-functional clinical research activities for itolizumab (EQ001), focusing on advancing clinical development programs through all phases of development, including contributing to and participating in regulatory submissions and meetings, taking a lead role in submission of INDs/BLAs and contributing to the strategy and execution of lifecycle planning for itolizumab (EQ001) and other pipeline molecules.

This role will be accountable for matrix deliverables carried by team projects within the broader clinical development team (internal/external). Examples of matrix team projects include the design, execution, and reporting of clinical trials, analysis of clinical and safety data at the conclusion of each phase of development including BLA/NDA submissions, contributing to medical affairs activities including KOL identification and management, advisory boards, and medical communication activities including publications, pharmacovigilance activities, and translational research and commercial projects. Key measures of success will include the ability to drive, coordinate and harmonize clinical development activities with multiple functional groups with the intent of delivering success by defining clear strategic development plans, communicating timelines and deliverables, ensuring appropriate accountabilities, and demonstrating an ability to lead teams/groups in hitting product development milestones.

Essential Duties & Responsibilities:

• Primary responsibility for the strategy, planning and execution of all clinical research activities.
• Provides strategic clinical input in regulatory documents: INDs, BLAs/NDAs, PSURs; Annual Safety Reports, Core Data Sheets, Investigator’s Brochures, Clinical Study Reports, Clinical Summaries and Clinical Overviews (risk/benefit evaluation).
• Collaborates with clinical, research, safety, regulatory, and commercial organizations to develop itolizumab (EQ001) lifecycle plans, including new indications.
• Responsible for leadership and management of all clinical development programs, building a clinical development team and oversight of drug safety function.

• Supports the Chief Medical Officer in presenting recommendations and securing senior leadership endorsement (Executive Leadership Team and Board of Directors) of clinical research plans and managing the communications on projects by monitoring and providing status update reports on key development projects from inception through implementation.

Job Requirements:

Education: 

• M.D. Required.
• Subspecialty or fellowship training in the field of allergy/immunology, nephrology, pulmonary, gastroenterology or rheumatology preferred.

Experience:

• Proven track record of exemplary leadership, high standards of professionalism and successful management of complex drug development projects within an integrated, high performing biotechnology or specialty pharmaceutical organization.
• In addition, this person will have previously served a minimum of 5 years in an integrative team leadership role where they were tasked with specific drug development projects, within clinical drug development and safety, global registration, and post-approval activities.
• It is preferred that the candidate have clinical development experience in areas of autoimmune and inflammatory diseases and in this role.
• The person will have provided strategic and operational leadership, implemented results-driven processes and gleaned the requisite experience in working collaboratively with both the research and commercial ends of the drug development spectrum.

Other key candidate qualifications include:

• Results-oriented drug development professional in developing and implementing global clinical development programs.
• A strong technical and commercial orientation coupled with a track record of successfully integrating Research and Development and Commercial teams by providing thought and operational leadership and valuable input to both development and commercially marketed programs.
• Ability to think strategically including the ability to set project goals and establish measures of success.
• An understanding of standard industry practices pertaining to Good Clinical Practice/ICH guidelines on the conduct of clinical research.
• General knowledge of US/EU drug safety and pharmacovigilance reporting requirements.
• Experience in data analysis and medical evaluation of clinical trial data.
• Hands on experience on regulatory submissions involving clinical trial data.

Skills and Attributes:

• 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 and different personalities.
• A combination of both solid business and sharp scientific acumen along with very strong presentation skills and the ability to listen and communicate to a wide variety of scientific and commercially oriented individuals.
• Pragmatic and analytical in his/her thinking and the ability take a reasoned position based on the integration of a diverse set of inputs.
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• High degree of professionalism, ethics and honesty with the ability to serve as a credible and passionate champion for Equillium’s breakthrough therapies.
• Strong computer literacy, including Microsoft Excel, Word, and most importantly the use of Power Point.
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment.
• Domestic and/or international travel requirement – up to 25%.

Position: Vice President, Regulatory Affairs and Quality

Position Level: Executive

Reports to: Chief Medical Officer

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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.