Director Clinical Development
Equillium (www.equilliumbio.com) is a clinical stage biotech company (NASDAQ:EQ) focused on developing novel therapies for severe and life threatening autoimmune and inflammatory diseases. Equillium’s initial product candidate, itolizumab, is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically-validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Biocon has recently reported results from a study of itolizumab in COVID-19 patients in India, and has subsequently received emergency use authorization from the Drugs Controller General in India for itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS). Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic and is developing itolizumab in multiple severe immuno-inflammatory disorders – acute graft-versus-host disease, uncontrolled asthma, and lupus nephritis – and is planning to submit an IND for the treatment of COVID-19 patients.
Overview of Position:
The primary objective of this position will be to serve as the lead for specific clinical development programs within Clinical Development and have direct contributions across all of the programs.
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. 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 planning and execution of clinical research activities for relevant programs.
- Provides 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, regulatory, and commercial organizations to develop EQ001 lifecycle plans, including new indications.
- Supports the VP, Clinical Development in presenting recommendations and securing senior leadership endorsement 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.
- M.D. or PhD or Pharm D required
- 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 3-5 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 pulmonary or infections diseases, but may have worked with autoimmune and inflammatory diseases.
- The person will have provided operational leadership, implemented results-driven processes and gleaned the requisite experience in working collaboratively with research but with exposure to the 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 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 intrapersonal 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 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%.
Equal Opportunity Employer