Head of Non-Clinical Development

Cambridge, MA, United States

Why join us?

LifeMine Therapeutics is a biopharmaceutical company pioneering Top-Down Drug Discovery, a bold new approach that leverages evolutionary insights from fungi to unearth next-generation precision medicines. Through our data-immersive and technologically expansive discovery engine, we are uniquely positioned to bring mechanistically and structurally novel precision medicines to patients in urgent need of breakthrough disease intervention.

LifeMine's data-immersive platform integrates the latest advancements in human genetics and genomics, bioinformatics, machine learning and synthetic biology. This convergence of technologies provides the ability to deeply mine fungal genomes for genetically encoded small molecules (GEMs). This Top-Down Drug Discovery approach prioritizes a molecule’s function (vs. its chemical structure) to identify pharmacologically privileged drug leads.

LifeMine's initial pipeline programs are focused on solid organ transplantation, antibody driven immune diseases, and antifungals. The Company is headquartered in Cambridge, MA, with offices in Gloucester, MA and Basel, Switzerland.

What is the opportunity?

LifeMine is seeking an accomplished leader to join our team as the Head of Non-Clinical Development. This role will be instrumental in driving our organization's preclinical strategy and overseeing the execution of non-clinical programs to advance our pipeline of innovative therapies. The ideal candidate will possess a unique blend of scientific expertise, strategic acumen, and leadership prowess, guiding cross-functional teams through the landscape of drug development. If you are passionate about translating scientific discoveries into tangible solutions that improve patients' lives and thrive in a dynamic, collaborative environment, we invite you to join us on this transformative journey.

Responsibilities

Oversee non-clinical study strategy and execution across the LifeMine research and clinical portfolio, including experimental approach, data package, and regulatory content to advance our development candidates

Implement efficient cross-functional processes across disciplines (pharmacokinetics, toxicology, bioanalytics, biomarker development, pharmacology) for execution of the non-clinical development strategy from discovery to document generation and filing.

Design and execute preclinical studies to guarantee readiness of drug candidates for clinical development and fulfilment of regulatory requirements.

Ensure analysis, interpretation and reporting of preclinical data packages generated both internally and with external collaborators

Establish effective relationships with CROs, consultants, and internal team members to develop and qualify various analytical and bioanalytical methods.Co-lead CRO work in the conduct of in vitro and in vivo studies. Review study protocols and reports, interpret and communicate results

Author, review and approve scientific reports that support regulatory documents including INDs, CTAs, and NDA filings.

Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments

Contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion

What you’ll need to be successful:

PhD in Pharmacokinetics, Pharmacology, Pharmaceutical Science or other relevant field with 15+ years of experience in the biopharmaceutical industry

Strong knowledge of small molecule nonclinical development, drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles

A track record of success with clinical development phases

Ability and Interest in leading dynamic, multi-disciplined project teams

Prior experience with regulatory submission (e.g., IND, NDA and/or BLA)

Exceptional influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders

Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment

Ability to promote a team culture that strives for continuous improvement, ownership, professional growth, and inclusion

Our Culture DNA

Our success at LifeMine is rooted in our unique Culture DNA, shaping how we innovate, collaborate, and achieve our mission. These values drive us forward, pushing the boundaries of science and delivering transformative medicines.

Collective Genius

We thrive on our ability to think and act as force multipliers for each other, and our collective strength lies in our collaborative spirit and the unique talents of our diverse team. Together, we push the boundaries of science and technology to mine groundbreaking medicines.

Inquisitive Expeditioners

We are pioneers at heart, driven by relentless curiosity to explore uncharted territories in drug discovery, leveraging evolutionary insights from fungi to lead the journey of innovation.

Inspired Learners

We embody a culture of perpetual growth and curiosity, where learning, teaching each other, and innovation intersect. This commitment to exploration and education ensures we remain at the forefront of delivering sophisticated, precision medicines.

Medicine Miners

Mining for high-impact medicines is fundamental to our identity. Through our data-immersive and technologically expansive discovery engine, we bring sophisticated medicines to patients in urgent need. We’re doing more than finding cures; we’re securing a healthier future for humankind.

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