Head of Translational Development

ABOUT ELEKTROFI

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other large molecule drugs, we create, develop, and commercialize subcutaneous biologic therapies in collaboration with strategic partners. We believe a patient-centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of BiologicsTM.

POSITION SUMMARY

Elektrofi is seeking a motivated individual to join our biotech company as Head of Translational Development to support the development of the novel Elektrofi formulation platform. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals. 

KEY RESPONSIBILITIES 

· Manage a team of approximately 8-10 scientists

· Develop a strong, mechanistic understanding of product performance in vivo – particularly with respect to immunogenicity, tolerability, and PK

· Identify critical quality attributes that may impact product performance and contribute to establishing functional specification ranges, at the platform level

· Analyze data and communicate findings to internal and external (partner) stakeholders to help inform (i) platform development and (ii) program-specific nonclinical and clinical strategies

· Work closely with leaders from other functional areas – e.g., Tech Development (formulation, process development), Tech Ops (MS&T), etc. – to ensure an effective and efficient approach to (i) above

· Assist with the authorship and review of various regulatory filings

· Contribute to health authority interactions

MINIMUM QUALIFICATIONS

· Ph.D. in science or health-related discipline or M.D.

· 20-30+ years of relevant industry experience

· Ideal candidates will have at least several years of experience in a large biopharmaceutical company

· Detailed understanding of complete drug development cycle – particularly for subcutaneously administered biologics (e.g., monoclonal antibodies) – and first-in-human use

· Detailed knowledge of domestic (FDA), European (EMA), and other international (ICH) regulatory guidelines and requirements, as well as experience in regulatory meetings

· Involvement with drafting and submitting multiple INDs and BLAs

· Extensive expertise in in vitro and in vivo immunogenicity analyses for SC mAbs, toxicology for SC mAbs (specifically tolerability), excipient qualification

· Ability to operate with a high degree of autonomy in a fast-paced, biotech environment

· Willingness and ability to work strategically but also tactically – i.e., roll up the sleeves and execute personally

· Strong work ethic and proclivity for self-starting

· Well-developed written and oral communication skills

· A collegial, team-oriented attitude

· Propensity for data-driven decision-making

Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. As part of our commitment to enhancing the in-office experience, we provide all employees with a commuter assistance program, offering support of up to $325 per month. Please apply at careers@elektrofi.com. 

EEOC Statement: 

Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms/employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms/employment agencies were engaged by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid.

All candidates must be legally authorized to work in the US.

#LI-Onsite