Director / Sr. Medical Director, Clinical Development

Company Description

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. Its lead program, EQ001, is a first-in-class anti-CD6 mAb that targets a novel co-stimulatory pathway involved in the activation, proliferation, differentiation and trafficking of T effector cells in autoimmune and inflammatory diseases. Equillium is currently conducting clinical studies  in GVHD, lupus nephritis, and Asthma. As Equillium advances EQ001, it is also considering expanding clinical development into other potential autoimmune indications.  Equillium has also recently acquired a pipeline of first-in-class, multi-cytokine inhibitors & product discovery platform from Bioniz Therapeutics. Potential new studies may include alopecia areata and celiac disease.

Position Overview: 

Equillium is looking for medical leadership to lead the clinical development of EQ001 and multi-cytokine inhibitors. This is a great opportunity for an experienced clinical development professional to take on a role in building and leading a fast moving and nimble development stage company in areas of high unmet need.

The primary objective of this position will be to serve as the lead for a specific clinical development program within Clinical Development and have direct contributions to potentially other programs.

This position will be responsible for directing and leading cross-functional clinical research activities 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. 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.

Summary of Key Responsibilities: 

Primarily responsible for the planning and execution of clinical research activities for relevant programs. Develop the clinical development program and trial protocols in collaboration with all  functions, vendors and consultants.
Leadership of the cross functional Clinical Development team in collaboration with all functions, as applicable for the agreed upon timelines and budget. Lead medical input for associated programs. Key contributor to monitoring safety and efficacy data in clinical studies and engaging with study investigators.
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 lifecycle plans, including new indications. Be involved in Business Development activities and due diligence.
Involvement in internal process improvement activities such as SOPs or guidance  documents, as assigned.
Potential to manage and mentor other clinical development team professionals and oversee medical monitor and safety review support.
Job Requirements:

Education:

M.D. required
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 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 hematology/oncology or rheumatology or other 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 working in global clinical development programs.
A strong technical and commercial orientation to provide thought and operational leadership and valuable input to both development and commercially marketed programs including strong clinical background.
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:

Leadership capabilities for cross functional teams
Good organizational skills, ability to work across locations/time zones and to work on several projects and assignments at the same time
Proven intrapersonal and influencing skills.  This includes a demonstrated ability to use an open and supportive communication style and to work cross functionally
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.
Strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies. 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.
A commitment to collaborative leadership, management, teamwork, delegation, and  the maintenance of a professional culture based on trust and mutual respect.
Strong computer literacy, including Microsoft Excel, Word, and most importantly the use of PowerPoint.
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 

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