Careers

Position: Vice President Biostatistics

Level: Vice President

Reports to: Senior VP Development Operations

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: Regulatory Affairs Manager

Level: Mid-Level

Reports to: Michael Son

Dept: Regulatory

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Overview of Position:

The Manager serves as the Regulatory Lead for mature products while managing, reviewing, planning and preparing complex regulatory submission documents for global regulatory filings. Among other responsibilities, the Manager will interpret regulations, and provide regulatory guidance to teams. The Regulatory Manager 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 Manager supports management with development and implementation of departmental strategies and policies.

Essential Duties & Responsibilities:

• Represent regulatory in cross-functional teams and communicate regulatory requirements to ensure optimal development and execution of global regulatory strategies
• Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration
• Research relevant regulatory precedents to bring innovative approaches to the cross‑functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on the development programs
• Ensure planned drug development activities comply with health authority guidelines, and in cases where they do not, provide a critical analysis of the associated risks and issues
• Support the drug development strategy, defining options for Scientific Advice, creating briefing packages and coordinating and leading US health authority meetings
• Coordinate the preparation, review and maintenance of regulatory submissions in collaboration with external partners including Clinical Trial Applications (CTAs), routine IND submissions, amendments, supplemental marketing applications, and routine reports
• Ensure effective implementation of filing plan and publishing of documents
• Ensure archiving of activities, especially submissions, internal memos and key correspondence
• Be responsible for communication of submission and approvals to relevant cross functional teams
• Plan, develop and write Standard Operating Procedures (SOP) to support the regulatory activities of Company. Interact with Company personnel to implement SOPs
• Define regulatory requirements, develop and subsequently implement plans in support of global/regional/country business initiatives
• Provide input into critical metrics and management reports
• Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects
• Proactively resolve issues related to outsourced activities
• Maintain a performance and improvement culture
• Proactively seeks out and recommends process improvements

Job Requirements:

      Education:

• Bachelors degree required. Advanced degree preferred
• 4-6 years’ regulatory affairs experience

      Experience:

• Managing and coordinating regulatory submissions (IND, NDA/BLA, amendments, supplements, annual reports, etc)
• Preparation and coordination of CTA submissions
• Interacting with FDA and/or other regulatory agencies

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
• Experience in successfully managing the operations of domestic and international clinical trials

Position: Scientist

Reports to: Sr. Director of Research

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: Director, Business Operations

Position Level: Senior Management

Reports to: Joel Rothman

Dept: Clinical Operations

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Overview of Position:

The Director of Operations will assess the needs of the company and ensure daily operations run as efficiently as possible. Responsible for managing company resources, implementing an operational plan and ensuring that procedures are carried out properly. Provide performance analysis and metrics reporting, execute site business continuity and risk management, prioritize key initiatives and portfolio projects, and drive continuous improvement. Strong organizational management with the ability to coach and develop high-performance teams and develop and implement program strategies. Ability to prioritize and communicate to staff key objectives and tactics necessary to achieve organizational goals with demonstrated experience in initiating, establishing and managing partnerships with academic institutions, government entities and companies, including the interplay between internal and external stakeholders.

Essential Duties & Responsibilities:

• Own site performance baseline and prioritization of operational improvements
• Develop standardized performance metrics and business processes for site reporting/consolidation
• Develop site operation excellence framework and serve as point of contact
• Work with cross-functional teams on developing business justification, investment plan (if required) and timeline for implementing operational improvements
• Drive cross-functional alignment on performance improvement, standardization and adoption of best practices for support activities
• Provide input into Capacity Planning, Workforce planning, Capital/Financial planning in alignment with operational improvement targets
• Generate site based business continuity plan, and roll out risk management programs to actively reduce and eliminate business risks
• Manage site project portfolio prioritization and execute site level strategic projects

Job Requirements:

      Education: 

• Bachelor’s degree in Science or Engineering with 5-8 years experience, or advanced degree (MS/PhD) preferred with 8+ years experience

      Experience:

• 7+ years’ experience in leading biopharmaceutical
• Proven Operational Excellence, with strong track record of driving continuous improvement
• Demonstrated project management and facilitation skills in collaborating and influencing geographically dispersed cross-functional teams
• Strong analytical and strategic thinking ability to recognize current barriers to improved performance, facilitate cross-functional/cross-site generation of innovative ideas and translate them into realistic actionable plans for implementation
• Demonstrated success in a cross-functional environment; effective interactions with diverse audiences of executives, mid-management, and subject matter experts and to inspire understanding and agreement
• Strong presentation and communication skills

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
• 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: Senior Director Program Management

Level: Senior Professional

Reports to: Joel Rothman

Dept: R&D

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Overview of Position:

The Safety Physician will lead and support the expansion of clinical development programs in support of the overall product development plan with a focus on development of the safety profile. This physician will serve as an ambassador and resource to various physicians and clinical trial sites, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Equillium customers, markets, business operations, and emerging issues, and perform other responsibilities as requested.

Essential Duties & Responsibilities:

• Primary responsibility for daily safety case review and will contribute to the design, analysis, interpretation, and reporting of safety findings within a program and will review and contribute to the content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents
• Primary responsibility for reviewing safety data periodically and on an ongoing basis to ensure quality control (QC) as required by program needs
• May participate in or lead review of protocol deviations (PD) which may impact patient safety as required by program needs
• May participate in, or lead safety development contributions to, due diligence or other business development activity
• Actively solicits opinion leader interactions; partners with Clinical leads, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Safety Development Plans and protocols as appropriate
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic and safety area. May represent Equillium at key external meetings
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serve as a safety representative for key regulatory discussions
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, organization policies and to all other quality standards in conducting research

Job Requirements:

      Education:

• MD, Board certified or eligible; PhD advantageous

      Experience:

• At least 2 years of experience strongly preferred

Skills and Attributes:

• Attention to detail, strong organizational skills, and ability to work independently and as part of a team
• Excellent time management and organizational skills
• Proven ability to manage multiple tasks and associated deadlines
• Exceptional communication and interpersonal skills
• Strong computer literacy and document management skills, including Microsoft Office suite
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
• 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
• Ability to exercise judgment and address complex problems and create solutions for one or more projects
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• This position’s primary work environment is in an office / traveling in the field as indicated