The Director/Senior Director, Regulatory Affairs will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. This individual will provide regulatory leadership and a sense of urgency to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives of the US Food and Drug Administration and other Health Authorities worldwide.
Provide regulatory strategic leadership for drug development projects, including but not limited to, health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives and timelines.
Serve as an influential and well-respected spokesperson with staff at FDA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements.
Provide de-risking development strategies and evaluating opportunities to accelerate development in a fast-paced environment.
Provide leadership, and when necessary, contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates.
Interpret and communicate regulatory expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations.
Contributes to the strategic leadership and development of policies, procedures and best practices commensurate with the requirements of a rapidly growing company.
Strong knowledge of FDA regulations and EU CTA requirements.
Prior experience and success with filing BLAs/MAAs. Experience with both early and late stage drug development.
Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities.
Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages and other regulatory submissions as required.
Experience interacting directly with the FDA and other health authorities.
Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required.
Experience with biologics drug development is highly desirable; experience in immunology/inflammation is a plus.
Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus.
Strategic thinker who can balance near term objectives with long term goals and outcomes.
Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience.
Ability to thrive in a collaborative and fast-paced team environment.
Education and Experience:
Bachelor’s Degree required, (PharmD, or PhD preferred).
Minimum of fifteen years of experience in regulatory affairs within the biopharmaceutical industry.
Internal Number: 3
About Kiniksa Pharmaceuticals
We are a privately-held clinical-stage biopharmaceutical company focused on discovering or acquiring, developing, and commercializing therapeutic medicines for patients suffering from devastating and debilitating diseases with significant unmet medical need. We have built a pipeline of product candidates across various stages of development, currently focused on autoinflammatory and autoimmune diseases. We have three clinical-stage product candidates, one of which is anticipated to commence a Phase 3 clinical trial in 2018. We have recently raised an additional $200M from new and existing investors, bringing the total to $320M since our inception in late 2015.
At Kiniksa, we are focused on hiring and retaining a highly skilled team that has extensive experience and specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a talented team to support our mission of building a global, generational company.
Our benefits are competitive, and we offer dynamic career opportunities across our organization fost...ering a culture that embraces passion and rapid execution.
Development Asset Details:
•Subcutaneously administered cytokine trap that inhibits the signaling of two soluble cytokines (product is already FDA approved via partner in alternative indication)
•Plan to initiate a Phase 3 trial in a rare, inflammatory cardiovascular disease where there are no currently approved therapies in 2018
•Monoclonal antibody inhibitor of a key growth factor for cells of myeloid lineage, licensed from global biopharma company
•Hundreds of patients’ worth of data in a large autoimmune condition through phase 2b with demonstrated competitive efficacy and safety profile
•Kiniksa plans to initiate a Phase 2 study in rare, inflammatory vessel disease
•Monoclonal antibody inhibitor of two key cytokines involved in pruritus, barrier dysfunction and fibrosis
•Recently completed enrollment in a Phase 1b study in subjects with cutaneous inflammatory disease which may provide both safety and efficacy data in the near-term
•Plan to initiate two proof-of-concept studies in inflammatory pruritic conditions in 2018
•Monoclonal antibody inhibitor of a key T-cell co-stimulatory pathway involved in T-effector memory cell function
•Plan to submit an IND in 2019
•Monoclonal antibody inhibitor of a central control node of T-cell dependent, B-cell mediated humoral adaptive immunity
•Plan to submit an IND in 2019
•Multiple ongoing discovery-stage projects