Tasca Therapeutics is a biotechnology company leveraging a unique drug discovery platform that identifies and maps novel lipid-binding pockets on proteins to develop new medicines to treat human diseases. A recently announced $52 million Series A financing, co-led by Regeneron Ventures and Cure Ventures, with participation by Invus Group allows us to advance our lead program, CP-383, a first-in-class molecule that has demonstrated robust anti-cancer activity in both in vitro and in vivo studies across a broad range of human cancers, into clinical studies. This molecule will initially be evaluated in small cell lung cancer, colorectal cancer, head and neck cancer, and brain cancer patients.
Tasca Therapeutics is seeking an experienced, collaborative, strategic executive physician to help build the vision and support the execution of its oncology clinical strategy. This is a leadership role that requires proven abilities to drive both strategic innovation and measurable business outcomes. The incumbent's track record of therapeutic expertise will be extensive and play a key role in the current and future business success of Tasca Therapeutics.
Job Responsibilities:
Develop strategic clinical development plans and oversee protocol design, execution, and data analysis/interpretation
Manage, build, and take responsibility for leading a clinical development team to execute on program goals in compliance with GCP, ICH, and other global regulatory requirements
Oversee the integration of biomarkers in clinical trials for patient stratification, identifying potential therapeutic targets, monitoring treatment efficacy, and ensuring the trials generate meaningful data.
Interface with global regulatory authorities and ethics committees, as appropriate, in support of the clinical development objectives; support the completion and approval of study-related documents
Lead efforts to identify, build relationships and communicate with key investigators and trial sites to ensure successful execution of clinical studies in compliance with global regulatory requirements
Direct study design, protocol development, and execution of clinical research for Phase 1 to 3 studies including pivotal cancer studies
Contribute to the overall clinical strategy of the ongoing clinical development program and product pipeline as well as giving in-depth clinical development advice on potential new oncology drug discovery programs
Generate/review clinical components of key documents in support of regulatory submissions, including clinical section of IND's and CTA's, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs
Ensure quality of all clinical documents (e.g., Investigators' Brochure, protocols, study reports, clinical components of regulatory submissions, safety related documents)
Provide scientific clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
Analyze and interpret data expertly, and clearly communicate results internally and externally
Act as primary Medical Monitor, monitoring the safety of enrolled subjects on assigned trials
Job Qualifications:
M.D. required; Board Certified preferred
Minimum of 10 years of clinical development experience in a biopharmaceutical or pharmaceutical company covering early-stage cancer clinical trials
Knowledge and understanding of early- and late-stage clinical trial design and global regulatory requirements
Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents
Clinical development experience within oncology/malignant hematology
Demonstrated ability to represent the Company in a variety of internal and external settings
Ability to develop and maintain relationships with key opinion leaders and thought leaders
Exceptional interpersonal, influencing, presentation, and written and verbal communication skills
Trustworthy with highest integrity; committed to ethics and scientific standards
Ability to prioritize, respond to directives, and work in a fast-paced and changing environment
Get-it-done-roll-up-your-sleeves attitude and committed to putting patients first
Must be located within and authorized to work in the United States today and in the future