Careers

Location: Nationwide (US)

COMPANY DESCRIPTION:

Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin^® gel in dermatology and iNexin^™ ophthalmic solution in ophthalmology.

Xequel Bio’s corporate office is located in Fort Worth, Texas and has a R&D office in Mt. Pleasant, South Carolina.

ABOUT THE POSITION:

The Vice President, Regulatory Affairs reports to the Chief Scientific Officer (CSO). The VP, RA, will be responsible for all Regulatory Affairs across the Company’s portfolio. The successful candidate will work cross functionally with the business having keen focus on CMC/RA for commercial stage products as well as all regulatory Health Authority submissions for the R&D programs.

JOB DUTIES:

• Accountable for the development, implementation, and maintenance of robust regulatory strategies to support global clinical trial activities, global registrations and product approvals, reintroduction of discontinued products and CMC regulatory compliance throughout the product lifecycle.
• Build critical relationships with Health Authorities that ensure successful interactions and outcomes.
• Provide regulatory support for new and ongoing clinical trials (e.g., clinical trial applications and import licenses, provide input for clinical protocols, labels, and other study related materials).
• Maintain current awareness of relevant global regulatory requirements.
• Identify and assess global regulatory risks, develop mitigation plans, and communicate changes in regulatory information to departmental and team colleagues.
• Coordinate regulatory submissions, including strategy for updating existing dossiers and submission of new INDs/CTAs/NDAs/MAAs, etc.
• Provide hands-on support in generation of regulatory documents.
• Ensures clinical and nonclinical data—in conjunction with regulatory strategy—are consistent with regulatory requirements and support the proposed product claims.
• Provide support for cGXP activities as the relate to regulatory affairs (e.g., inspections).
• Provide support for responding to queries from Health Authorities and for preparing for meetings with regulatory agencies.
• Monitor progress of the regulatory authority review process through appropriate communication with the agency.
• Ensure and facilitate communication among executive management, peers and associates; proactively communicate critical situations in an adequate and timely manner to interdisciplinary teams and to appropriate management level in CMC/RA, QA, TechOps and R&D as appropriate.
• Liaise with all relevant groups to ensure high quality documentation is developed.
• Collaborate with CSO in all development activities.
• Contribute senior level operational and strategic regulatory input into BD&L and oversee Due Diligence evaluations.

QUALIFICATIONS:

• +15 years of experience in global Regulatory Affairs with experience in ophthalmology, pulmonology, and dermatology.
• Demonstrated leadership excellence in building and maintaining Health Authority relationships, influencing people, negotiation and communication skills.
• Potential/ability to coach and develop people and teams and to recruit to support the talent pipeline.
• Excellent working knowledge/experience in regulatory submission and approval processes and proven practical knowledge of and ability to resolve complex CMC regulatory issues.
• Proven track record of successfully leading teams, planning, coordinating and leading activities simultaneously on multiple projects.
• Regularly demonstrated active contributions to line functions or project teams.
• Demonstrated leadership in risk assessment and mitigation, strategic thinking, and maintaining awareness of business impact.
• Demonstrated ability for innovative, strategic and big picture thinking.
• Strong interpersonal, organizational, communication, presentation, negotiation and problem-solving skills.
• Computer literacy (e.g. MS Project, PowerPoint, document management systems) available and shown ability to quickly learn new software, tracking tools and associated processes.

Job Title: Senior Director, Clinical Development

Department: Research & Development

Location: Fort Worth, Texas

Classification: Exempt

COMPANY DESCRIPTION:

Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alphaConnexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin® gel in dermatology and iNexinTM ophthalmic solution in ophthalmology.

Xequel Bio’s corporate office is located in Fort Worth, Texas and has a R&D office in Mt. Pleasant, South Carolina.

ABOUT THE POSITION:

Provides operational oversight for clinical phase studies and personnel. The Sr. Director of Clinical Operations reports to the Chief Scientific Officer and works closely with Therapeutic Area Heads across Clinical activities. Provides guidance and experience across functional areas including R&D, Project Management, Finance, Regulatory, and Quality Assurance.

JOB DUTIES:

• Oversees the direction, planning, execution, and interpretation of clinical trials research, data collection activities, and clinical operations either directly or indirectly through oversight of CROs and vendors.
• Co-author (along with Therapeutic Area Heads) and reviewer of clinical trial design, clinical study protocols, and clinical study reports.
• Participates in and leads selection of CROs and vendors for appropriate project needs.
• Monitors adherence to protocols and determines study completion. 
• Manages clinical and regulatory files and maintains clinical inventory intended for distribution to investigational sites.
• Ensures R&D compliance with policies, guidelines, and standards adhering to ICH-GCP as well as local, regional, and national regulations.
• Author and reviewer of clinical development SOPs for implementation and adherence on subject matter expertise.
• Implementation and adherence to clinical study execution Key Performance Indicators.
• Develops and implements solutions to ensure compliance.
• Develops and reviews contracts and budgets based on project needs. 
• Assists in the design and implementation of business strategies to meet business goals.

QUALIFICATIONS:

• Ph.D. or Master’s Degree in Life Science discipline (or relevant field) or Bachelor’s degree with compensating experience
• Prior clinical operations experience in the Pharmaceutical, Biotechnology, Academic, or contract research organization (CRO) setting
• Prior clinical project management experience in early and late phase trials (Phase I-III)
• Must have familiarity with clinical research concepts, practices, FDA regulations, and ICH Guidelines regarding drug development phases, clinical research, and data management methods
• Exceptional verbal and written English language communication skills 
• Ability to travel domestically up to 45% and international as needed on case-by-case basis
• Strong written and verbal communication skills
• Ability to meet deadlines within scope of project, including within budget and timelines
• Proficient in Microsoft applications including Word, Excel, PowerPoint, and Outlook
• Strong analytical and strategic thinking skills
• Ability to work within appropriate escalation pathways
• Strong regulatory knowledge of clinical development
• Experience leading cross-functional teams