Company Overview:
Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery.
Our lead program, STX-001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.
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Job Summary:Strand Therapeutics is seeking a dynamic senior leader to build and direct our In Vivo Sciences, Pharmacology and Preclinical Toxicology/Safety functions in support of growing mRNA therapy portfolio. This department spans across in vivo sciences, pharmacology, safety/toxicology, and DMPK/bioanalytical sciences. This leader will provide both strategic and hands-on leadership in designing and executing comprehensive preclinical strategies (including in vivo oncology pharmacology models, non GLP and GLP toxicology studies) that drive IND enabling programs and advance novel mRNA-based therapeutics.
The position reports to the Senior Vice President of Research & Translational Development (R&TD) and is a key part of a cross-functional team dedicated to bringing transformative mRNA therapies to patients.This is a high-impact leadership role responsible for shaping research and development strategy and building Strand’s portfolio of therapeutic programs and platforms. The Senior Director will collaborate extensively with other functions within Research (mRNA Discovery, LNP Discovery, Computational Biology), CMC/Technical Operations, Clinical Development, Quality, and Regulatory Sciences. This will ensure preclinical efforts are well-integrated with overall company goals and there is seamless transition from bench to the clinic. Additionally, this role offers the opportunity to develop internal pathology and DMPK capabilities and to partner with the Clinical Management group on correlative biomarker endpoints that connect preclinical findings to upcoming clinical trials. A strong, adaptable leader who can contribute at the strategic level while also “on the ground” supporting program execution is highly desired.Primary Responsibilities:
- Provide strategic leadership for Strand’s Translational Development organization that encompasses pharmacology, toxicology/safety, DMPK, and bioanalytical functions, to advance our mRNA therapeutic pipeline.
- Design and oversee the execution of comprehensive preclinical study plans, from early discovery through IND-enabling studies, including development of innovative in vivo oncology pharmacology models and GLP toxicology studies to evaluate safety and efficacy of drug candidates.
- Responsible for running the in vivo sciences group that is responsible for planning and executing all of Strand’s internal animal studies as well as maintaining regulatory compliance.
- Oversee the planning and conduct of IND-enabling studies as needed in collaboration with external CROs, ensuring all regulatory requirements are met for IND submissions.
- Ensure robust data generation and analysis by establishing strong bioanalytical and DMPK capabilities (e.g. pharmacokinetic, pharmacodynamic, and biomarker assays) to support preclinical studies and regulatory filings.
- Build, mentor, and manage a high-performing multidisciplinary team (in vivo scientists, pharmacologists, toxicologists, and bioanalytical scientists), while establishing new internal capabilities in Pathology and DMPK.
- Collaborate with computational biology, bioinformatics, and data science teams to leverage multi-omics, AI, and machine learning tools for target validation, biomarker discovery, and translational insight.
- Collaborate cross-functionally with key departments, such as Technical Operations/CMC, Clinical Development, Regulatory Sciences, Quality, and Finance, to align nonclinical study plans with overall program objectives and regulatory strategies.
- Partner closely with the Clinical Development group to develop correlative biomarkers and endpoints, ensuring that in vivo preclinical findings inform clinical trial design and translational research efforts.
- Serve as a core member of the R&D leadership team, contributing to high-level platform and program decisions and helping shape the overall research and development strategy for Strand.
- Manage external research partners and Contract Research Organizations (CROs) to drive high quality study execution and on-time delivery of results, including negotiating study designs/timelines and reviewing study reports for regulatory submissions.
- Oversee departmental budgets and resource allocation, setting goals and metrics for departments to support current projects and future growth.
- Contribute to authoring and reviewing nonclinical sections of regulatory documents (e.g. IND submissions) and representing the nonclinical function in meetings with regulatory agencies as needed (leveraging prior regulatory interaction experience).
- Foster a culture of scientific excellence, collaboration, and inclusion, and actively promote professional development and succession planning across the Translational Development team.
Qualifications:
- PhD or equivalent advanced degree in Toxicology, Pathology, Pharmacology, Cancer Biology, Immunology or a related life science field, with experience contributing to regulatory submissions especially in the cell and gene therapy field including mRNA.
- 7-10+ years of biopharmaceutical drug development experience in preclinical and translational space, including substantial involvement in nonclinical studies for therapeutic programs.
- Proven experience leading cross-functional teams, with a demonstrated ability to recruit, mentor, and develop scientific staff and build new functions or departments.
- Strong interpersonal and leadership skills, with the ability to motivate others, influence without formal authority, and foster a collaborative team environment.
- Excellent problem-solving and critical-thinking abilities, along with superb communication skills to effectively distill and present complex scientific data to diverse stakeholders.
- Strategic thinker with the ability to balance short-term and long-term objectives, and a proven adaptability to thrive in a dynamic, fast-paced startup environment.
- Demonstrated ability to drive high-quality preclinical studies, manage CRO partnerships, and ensure thorough data analysis and reporting in support of regulatory filings.
- Experience with departmental budget planning and goal setting to build capabilities and meet program needs.
Preferred Qualifications:
- Board certification in toxicology (e.g. DABT) or Veterinary Pathology (e.g. DACVP), reflecting advanced credentials in nonclinical sciences.
- Direct experience with mRNA-based therapeutics or other advanced modalities (in addition to cell and gene therapy experience).
- Involvement in regulatory agency interactions and support of programs through IND filing and into early clinical (post-IND) development.
- Demonstrated leadership in building or scaling internal translational capabilities, including development of in-house pathology, DMPK, or biomarker platforms.
Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.
Strand does not accept unsolicited resumes from any source other than directly from candidates.Job Type: Full-timeSalary: Commensurate with role and experience
