Company Description mAbTree Biologics is a biotech company based in Basel, Switzerland, dedicated to developing affordable, innovative monoclonal antibody therapies for hematological cancers and autoimmune diseases. Founded in 2019, the company focuses on making cutting-edge immunotherapies accessible to patients worldwide, particularly in underserved areas of oncology and hematology. Its lead product, MT-0002, is a fully human antibody targeting a unique tumor marker and has demonstrated promising preclinical data, including tumor reduction and depletion of mutant hematopoietic stem cells in myeloproliferative neoplasm (MPN) models. mAbTree Biologics is preparing for clinical trials and pursuing strategic partnerships and investments to accelerate development and regulatory approval by 2025.

The company is also pursuing orphan drug status to speed patient access to these novel therapies.

Role Description We are seeking an experienced Senior Translational Scientist / Project Leader to drive the scientific strategy and cross-functional project management of biologics and RNA therapeutic programs from early preclinical discovery through IND/CTA-enabling studies and regulatory submission. The successful candidate will have a demonstrated track record of advancing multiple molecules — monoclonal antibodies and/or RNA-based modalities — through target evaluation, candidate characterization, non-clinical pharmacology/toxicology, and into regulatory filing across major and emerging health authorities (FDA, PEI/EMA, and CDSCO). This is a high-visibility role requiring both deep scientific expertise and strong program/project leadership skills, with direct interaction with CROs, KOLs, and regulatory agencies.

Key Responsibilities

- Serve as scientific and strategic project leader for one or more biologics (mAb) and RNA therapeutic programs, guiding candidates from discovery/target evaluation through preclinical proof-of-concept, IND/CTA-enabling toxicology,



and into early clinical development.
- Design, oversee, and interpret translational pharmacology, PK/PD, biomarker, and disease-model studies to support go/no-go decisions and target product profiles.
- Lead cross-functional, multidisciplinary project teams (biology, CMC, toxicology, regulatory, clinical) and align stakeholders on scientific strategy, timelines, risk mitigation, and budgets.
- Participate and coordinate IND (FDA), CTA (Swissmedic/PEI/EMA), and CDSCO submission packages, including non-clinical study reports, investigator's brochures, and briefing documents for regulatory interactions.
- Join with CMO and clinical team in interactions and meetings with regulatory agencies (FDA, PEI, other EU competent authorities, CDSCO) and coordinate responses to agency questions.
- Plan, contract, and manage a global CRO network for GLP/GCP-relevant preclinical and early clinical studies, ensuring scientific quality, timelines, and budget adherence.
- Prepare and deliver scientific and strategic presentations to senior management, the Scientific Advisory Board, investors, and external partners.

Ensure all program activities comply with GCP, GLP, and applicable international regulatory guidelines.

Qualifications

- PharmD, PhD, or equivalent doctoral degree in pharmacology, molecular/cell biology, biochemistry, or a related life-science discipline.
- 10+ years of post-doctoral experience in translational science and drug development within academia and/or the biotech/pharmaceutical industry.
- Demonstrated success moving multiple molecules (small molecule, mAb, and/or RNA/mRNA modalities)



from early discovery through IND/CTA-enabling preclinical development.
- Hands-on project management experience with monoclonal antibody and RNA therapeutic programs, including candidate selection, characterization, and non-clinical development planning.
- Direct experience preparing and/or supporting regulatory submissions and interactions with FDA, PEI/EMA, and CDSCO (or comparable health authorities).
- Strong working knowledge of GCP and non-clinical/clinical trial planning, PK/PD, toxicology, and biomarker strategy.
- Proven CRO management experience, from research through preclinical development and CMC coordination.
- Excellent stakeholder management, relationship-building, and communication skills, with experience presenting to management, boards, and external audiences.
- Project management qualification (e.g., PRINCE2) or equivalent demonstrated project leadership experience is a strong asset.
- Track record of successful grant and patent writing.
- Fluent in English (business level)

Preferred Experience

- Experience across multiple disease areas, e.g., oncology, immuno-oncology, dermatology, regenerative medicineor rare disease.
- Prior leadership role such as Director/Head of Translational Science, Translational Research Director, or Project Leader Biology & Clinical Translation.
- Experience in preclinical & clinical project management.
- Familiarity with clinical trial management and GCP certification (e.g., CAS/CTM certification).
- Publication record in high-impact, peer-reviewed journals and experience with grant/non-dilutive funding acquisition.

What We Offer

- The opportunity to lead scientifically and strategically important biologics and RNA therapeutic programs from bench to IND/CTA within a fast-growing biotech.
- A collaborative, multicultural, multidisciplinary team workplace with direct access to senior leadership and the Scientific Advisory Board.

📌 Senior Translational Scientist / Project Leader – Biologics & RNA Therapeutics (India)
🏢 mAbTree Biologics
📍 India