KEY RESPONSIBILITIES​​

Program Leadership & Delivery

• Develop and manage integrated project plans, timelines, budgets and resources across all pre-clinical IND-enabling programs through to early clinical development.

• Coordinate and monitor pre-clinical studies, including in vitro and in vivo studies, ensuring alignment with program goals and regulatory requirements (GLP, FDA/EMA).

• Track project progress against critical path milestones; identify risks early and implement mitigation strategies to maintain timelines and deliverables.

• Prepare or support the creation of regulatory submissions, including pre-IND packages, IND filings and Investigator Brochures.

• Oversee data collection, analysis and documentation for pre-clinical studies, ensuring data integrity and GxP compliance throughout.

 

External Partner & CRO Management

• Identify, evaluate and manage relationships with CROs, CDMOs and other external vendors; negotiate contracts, oversee budgets and ensure delivery of high-quality study outputs.

• Serve as the primary operational point of contact between internal departments (Research, Toxicology, Pharmacology, CMC, Regulatory Affairs) and external partners.

• Review Statements of Work (SOWs) and process CRO contracts; track spend against budget and flag variances in a timely manner.

• Build and maintain a panel of scientific advisors and subject-matter experts accessible within and outside the organization.

• Support business development partnering processes, drawing on prior experience of external collaborations and licensing discussions.

 

Scientific Assessment & Strategic Input

• Critically assess in vivo and in vitro experimental results; provide go/no-go recommendations based on an integrated, cross-functional view of the data.

• Contribute to the design and development of pre-clinical study strategies to support clinical translation, including ADME/PK, safety pharmacology and IND-enabling toxicology.

• Monitor the competitive environment in pharma/biotech and provide input to pipeline prioritization discussions based on emerging data and scientific trends.

• Present program updates, study results and strategic recommendations clearly at internal management committees and in regulatory interactions.

 

Cross-functional Collaboration

• Facilitate communication and collaboration among multidisciplinary teams, including Research, Clinical, CMC, Regulatory Affairs, Business Development, Legal, and IP, to achieve program milestones.

• Report project status to leadership (Directors, VPs, Executives) with clarity on timelines, budgets, risks and next steps.

• Contribute to change management within the organization; help influence ways of working as the pipeline and team scale.

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Government Contract Management

• Oversee the execution of government-funded research contracts (e.g., NIH, ARPA-H, DoD/DARPA), including milestone tracking, deliverable reporting, and coordination with program officers.

• Ensure compliance with federal grant requirements, including budget management, progress reporting, and adherence to applicable regulations (FAR, 2 CFR Part 200, or equivalent).

• Coordinate across multi-site academic and industry consortium partners to align scientific workplans with contractual obligations and government reporting timelines.

• Support preparation of technical reports, budget justifications, and other documentation required for government contract renewals, amendments, and close-outs.

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CANDIDATE PROFILE
Essential Qualifications & Experience

• PhD in Biology, Pharmacology or a closely related discipline; post-doctoral experience in the field is strongly preferred.

• 10+ years in a bio-pharmaceutical environment, with a minimum of 5–8 years in pre-clinical research and development; experience as a drug discovery project leader with FIH study experience is required.

• Thorough, hands-on understanding of all phases of pre-clinical drug discovery: target identification, lead optimization, IND-enabling studies (GLP toxicology, ADME/PK, safety pharmacology), and early clinical development.

• Demonstrated track record of publications in high-quality, peer-reviewed scientific journals.

• Direct experience managing CRO and CDMO relationships, including contract negotiation, SOW review and vendor performance management.

• Familiarity with FDA/EMA regulatory guidelines for drug development; experience supporting pre-IND or IND submissions is an advantage.

• Understanding of the competitive landscape in pharma/biotech; some experience in external partnering or licensing processes.

 

Skills & Competencies

• Strong organizational and project management skills; able to manage multiple programs simultaneously using standard project management tools and principles.

• Ability to clearly communicate scientific content, including complex study data and program strategy, to both technical teams and senior management committees.

• Proven ability to work in a multidisciplinary environment spanning research, clinical, CMC, BD, legal, and IP functions.

• Capable of understanding and deducing partner perspectives; experience navigating partnering and licensing discussions is an advantage.

• Adaptive approach to change management; able to influence the organization without direct line authority.

• Proactive, creative, and enterprising attitude; open to innovation and motivated by science.

• Comfortable operating across two distinct scientific platforms (small molecule therapeutics and gene therapy/medical devices) and managing priorities across parallel programs.

• Experience managing government-funded contracts or grants (e.g., NIH, ARPA-H, DoD); familiarity with federal reporting requirements and multi-institution consortium management is a strong advantage.

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WHY JOIN US​

This role sits at the heart of two compelling and scientifically distinct General Inception portfolio companies, each tackling major unmet needs in human health.

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ResolveM

ResolveM is developing macrophage-directed therapeutics that target the root cause of chronic inflammation and fibrosis — restoring immune balance rather than masking symptoms.

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SonoNeu

SonoNeu is a General Inception spinout pioneering sonogenetics — a non-invasive platform that uses ultrasound to control engineered ion channels for as a novel therapeutic modality.

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Across both companies, this role offers direct program delivery responsibility, close working relationships with scientific leadership and world-class academic, pharma, and government agency partners, and a clear line of sight to meaningful clinical milestones. The position is fully remote and suits a scientist-operator who thrives at the intersection of rigorous science, operational execution, and strategic impact. We offer a competitive salary, and a flexible remote working environment.

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Please submit your CV, a brief cover letter outlining your fit for this role, and a representative publication to venkat.reddy@generalinception.com. We review applications on a rolling basis and encourage early submissions.