Who We Are
BlackThorn Therapeutics is a neurobehavioral health company developing targeted therapeutics, informed by a deep understanding of brain and behavior relationships, to significantly improve patient outcomes. The company has pioneered a proprietary computational psychiatry platform, which leverages bioinformatics, neuroinformatics and artificial intelligence technologies, with the goal of determining a patient's distinct neuroprint to inform the proper on-target treatment option for biologically defined patient subtypes. BlackThorn Therapeutics has completed a Phase 1 trial of BTRX-335140, a selective kappa opioid receptor antagonist, and is conducting IND-enabling studies for BTRX-323511, a selective vasopressin 1a receptor antagonist. The company also has a drug discovery program directed at novel therapeutic targets for neurobehavioral disorders.
The Position
We are seeking an enthusiastic and innovative pharmaceutical physician with 5-10 years of industry experience to join our clinical team reporting to the Chief Medical Officer. Under the oversight of the CMO, the Director/Senior Director of clinical development is responsible for directing the design and execution of clinical studies in order to successfully move programs through the clinical research process in a timely manner, in adherence with GCP, appropriate SOPs, and government regulations.
S/he will be a key contributor in building an integrated development plan and will provide support to new development activities, as well as clinical guidance and assessment of future opportunities to advance the science.
This is a unique opportunity to join and build, with like-minded colleagues, a company that aims to transform the lives of individuals with neurobehavioral disorders.
Essential job functions:
- Contribute to the strategic development of clinical programs leveraging BlackThorn’s unique technologies and data insights
- Provide clinical development and medical leadership/oversight of clinical programs to ensure timely delivery of clinical deliverables
- Ensure clinical programs support patient safety and to provide oversight of patient safety in clinical trials
- Active membership of cross functional project teams
- Provide medical oversight of information included in regulatory documents (e.g., clinical sections of IND/NDA/CTD submissions, periodic safety updates, briefing documents and responses to questions from regulatory authorities or EC/IRBs
- Development of clinical documents (e.g.) Study concepts/ synopses, clinical protocols, investigator’s drug brochures (IB), clinical study reports (CSR), ICF, and other documents
- Review, analyze, interpret, and present both clinical and translational data both internally and externally
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications. Support publication strategy execution including collaboration with investigators, KOLs, and other internal/external stakeholders. Present at investigator meetings, advisory boards and scientific conferences
- Assist in development of in-house clinical SOPs, guidelines and systems as necessary
Who You Are
- M.D. or D.O.
- Strong back ground in clinical trial design and execution. The ideal candidate will have 5-10 years pharmaceutical industry experience, ideally in neurobehavioral drug development and including interacting with regulatory authorities. Experience of early phase or translational studies would be an advantage.
- Demonstrated ability to evaluate, interpret and present complex scientific data
- Committed to the values of integrity, collaboration, accountability, transparency and drive
- Ability to think strategically and tactically
- Ability to work collaboratively and deliver results in a dynamic and fast paced environment
- Ability to effectively lead, develop, mentor and manage others
- Be able to identify challenges and provide solutions in a proactive manner
- Excellent verbal and written communication skills
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.