Director, Translational Medicine
2 weeks ago
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 Director of Translational Medicine to lead and manage the team in its research and development endeavors. This leader will join a dynamic, multidisciplinary team of scientists and engineers to advance the maturation of the platform technology by intimately characterizing the translational impact of a range of CMC parameters. The Director will also lead and manage many of the translational development activities associated with our growing portfolio of partnered programs. This role requires expertise in regulatory affairs, nonclinical development, and a deep understanding of novel drug formulation and delivery systems.
KEY RESPONSIBILITIES
- Manage the Translational Medicine team to most efficiently allocate resources to achieve the team’s annual goals.
- Manage a portfolio of development programs by leading study design, data analysis/interpretation, technical reporting, and communication.
- Participate in the authorship of regulatory materials and regulatory interactions.
- Lead and oversee translational medicine strategies and team (In Vivo, In Vitro, Drug Product Translation) to support the development of novel protein formulations for subcutaneous delivery.
- Provide strategic and scientific guidance on the translation of Chemistry, Manufacturing, and Controls (CMC) decisions to optimize translational performance.
- Collaborate closely with cross-functional teams to ensure alignment of CMC, nonclinical, and clinical development strategies.
- Assess and mitigate risks related to subcutaneous injection site local tolerability and immunogenicity of protein formulations using in vitro (immune cell culture), ex vivo (skin biopsy), and in vivo (mouse, rat, rabbit, minipig, NHP) models.
- Utilize pharmacological expertise to optimize formulation design and performance.
- Develop and maintain strong partnerships with pharmaceutical collaborators to advance joint development programs.
- Implement stage-gate or decision-gate processes to evaluate technology maturity and progression.
- Contribute to regulatory submissions and interact with regulatory agencies to ensure compliance and support approval processes.
MINIMUM QUALIFICATIONS
- PhD or equivalent degree in a relevant scientific discipline (pharmaceutical sciences, pharmacology, biochemistry, etc.) and extensive industry experience (12+ years) in translational medicine, with several nonclinical regulatory engagements and a focus on drug development or drug delivery.
- Experience managing functional and cross-functional teams with regular updates to senior management.
- Strong understanding of pharmacology, particularly related to protein therapeutics and subcutaneous injections.
- Experience with assessing and managing local tolerability and immunogenicity risks of protein formulations.
- Deep experience with the analytical characterization of drug products such as protein and/or particles.
- Familiarity with pharmaceutical partnership development and management.
- Knowledge of stage-gate or decision-gate processes in drug development.
- Excellent communication and leadership skills, with the ability to collaborate effectively across diverse teams.
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 $315 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 United States
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