THE ARTAC SEEL CO – 860-535-4419
Head -Clinical Development
Location: Cambridge MA
The client is searching for a Head of Clinical Development to translate our patient focused genomic drug discovery platform into clinical trials. This individual will lead the design and implementation of early phase clinical oncology studies to assess product pharmacology and safety and to achieve Phase I/II proof of concept in highly enriched patient populations
- Provide clinical insight and strategic direction to focus the company’s entire portfolio towards clinical success.
- Prepare study designs and protocols, clinical development plans and clinical sections of INDs.
- Collaborate cross-functionally with Clinical Operations, Regulatory, Clinical Pharmacology, Pharmacovigilance, Data Management and Biostatistics to ensure GCP-compliant study conduct, timely data base lock, analysis and reporting of Phase I/II studies within the project timelines
- Represent the company on and lead Project Teams. In addition to study oversight, Project Team deliverables include preparation, submission, and updating of clinical sections of Investigator Brochures and of IND/CTA dossiers.
- Partner with other internal functions to communicate information to external stakeholders, meeting appropriate legal and regulatory requirements
- Foster collaborative relationships with an expanding network of KOLs; tap into KOL expertise via informal interactions and advisory boards to inform clinical development plans for proof of concept studies and future development opportunities.
- Assist Business Development initiatives with assessments and intelligence for both in-licensing of potential new products and out- licensing or collaborations/partnerships of H3 assets.
- Design and implement company’s clinical programs including First in Human and Phase I/II proof of concept (PoC) studies, with clear “go-no-go” criteria.
- Work effectively cross-functionally to ensure that protocols, informed consent forms, data collection and analysis plans are GCP compliant and meet regulatory and other stakeholder requirements.
- Provide clinical input on study site selection and training, and medical monitoring for phase I/II clinical trials, including assessment of eligibility questions, protocol violations, co-morbidities and concomitant medications, management of drug-related toxicities, and criteria for efficacy
- Act as a senior company representative interacting with external scientific leaders and regulatory authorities.
Education & Experience Requirements
- Medical Degree required plus PhD Biological Sciences preferred.
- 5+ years of experience in the Pharmaceutical Industry including relevant oncology focused drug development experience (preferably in experimental medicine, translational medicine, or clinical pharmacology).
- Strong relevant clinical research experience in academic or other settings may substitute for Pharmaceutical Industry experience.
- Experience in designing and conducting Phase 1-2 clinical trials required, preferably in a personalized medicine setting; clinical pharmacology and biomarker development expertise preferred.
- Familiarity with IRB, ICH, FDA and GCP guidelines governing clinical trial design and conduct, biomarkers, pharmacogenomics and clinical technologies.
- Demonstrated ability to collaborate with R&D and Commercial functions.
- Experience in IND/CTX/NDA/MAA submissions and interactions with Regulatory authorities.