Director/Senior Director, Clinical Development at TrialSpark (Greater NYC Area, NY)
TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.
The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.
TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.
Achieving this goal of the growth of TrialSpark will require an energetic, highly motivated, experienced and creative world class Medical Team. We need you to be part of that journey: As a key member of the team, based on your clinical development experience you will be responsible for providing medical input into our Business Development strategy and execution, lead the development of the Clinical Development Strategy and Plans, including protocol development, for clinical studies. As part of this responsibility you will provide strategic input to the execution of clinical studies as a project physician.
Your ability to understand and navigate the complexities of healthcare data and clinical trials will be essential to your success and the success of TrialSpark. In addition, the ability to work effectively in a matrix environment and to communicate effectively across multiple stakeholders is essential. It will also be essential that you are a creative problem solver with the ability to drive new ways of doing drug development.
Clinical study planning and execution
- Development of protocol concepts, protocols and clinical development plans
- Medical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy considerations as well as commercial needs.
- Medical monitoring and oversight of phase 2-4 trials
- Provide medical input to business development candidates
- Direct participation in calls with potential licensing candidates
- Work closely with the BD team to develop deal models through your experience in clinical development
- Based on review of the scientific landscape contribute to therapeutic areas strategy
- Based on the clinical trial design landscape contribute to study design and planning strategy
- Drive/contribute to trial operations and medical processes to achieve continued innovation and improvement
- Utilize your clinical development and trial execution experience to develop creative ways to speed up clinical trials in an efficient and
- Clinical training for internal stakeholders and clinical trial sites (e.g. overviews of specific disease areas, drug mechanisms of action, protocol requirements, etc.
- Input into patient recruitment tools
- Ideas for recruitment strategies - i.e. creative ideas for where we can find patients
- At least 5 years experience in biotech (preferred), pharma or CRO to include protocol development and medical oversight/monitoring of phase 2-4 studies (final title to be determined by experience level)
- MD/DO degree (or equivalent) required
- Board certified by accredited speciality board - Internal Medicine preferred
- Experience with health authority interactions and contributions to regulatory filings preferred
- Excellent written and verbal communication skills
- Strong analytical skills
- A “roll-up-your-sleeves” attitude
- Track record of cross functional leadership
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.