CAREERS

Title: Sr. Clinical Research Associate

Reports to: Sr. Director, Clinical Operations

Dept: Development

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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 manage clinical studies including site and/or vendor oversight.

Essential Duties & Responsibilities:

• Coordinates 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
• Provides review and input on study-specific plans
• Review of clinical protocols and amendments
• Performs operational feasibility assessments for new clinical protocols
• Identifies and recruits clinical investigators
• Review and management of regulatory documents
• Coordinates the review and content of study materials such as eCRFs, study guides and subject instructions
• Assists with the preparation, conduct and presentations for CRA Training at Investigator Meetings
• May assist with coordination and management of study budgets
• Manages the overall Investigational product accountability and reconciliation process
• Assists with the review and oversight of data for quality (e.g. ensures that CRF data queries are resolved)
• Coordinates CRO tracking, and training, including lab samples for central laboratories
• Reviews outsourcing specifications for RFPs
• 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
• Assists in the preparation of data and documents for inclusion in items such as: Clinical Study Reports, Annual IND safety reports and clinical summaries, as needed
• Review of monitoring reports. Identification and escalation of issues and assists with corrective action plans.
• Intermittent monitoring of clinical sites for adherence to protocol and GCP
• May complete PSSV or other site visits in assistance of CRO and to promote timeline
• Other duties as assigned

Job Requirements:

Education: 

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

Experience:

• 5 years related experience in life sciences or medically related field, including 4 years of experience in industry within Clinical Development (i.e. 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 events
• Experience with interactions with outside vendors (i.e. sites, CROs, contract labs)
• 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: Microsoft Excel, Word, Outlook and PowerPoint
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
• Travel required 20-50%

Position: Sr. Director, Clinical Development

Position Level: Sr. Director

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 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 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 EQ001 lifecycle plans, including new indications.
• Responsible for leadership and management of a clinical development team (clinical operations, biostatistics, data management, safety, regulatory) which includes oversight of daily clinical activities and performance of the internal and external team.
• Supports the Chief Medical Officer in presenting recommendations and securing senior leadership endorsement (Executive Committee 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%.