Senior Medical Director, Clinical Development at TrialSpark
The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the development process takes nearly a decade and frequently costs $1B+. And the problem is only getting worse.
TrialSpark is a technology company that brings new medical treatments to patients faster. We’re reimagining the clinical trial by introducing a new model, using technology to streamline every aspect of the trial. To fulfill our mission, we partner with pharma, biotech, and digital health companies to run studies faster and more efficiently.
This is a key role in the growth of our Medical Team. You will be responsible for providing medical leadership and support to our Clinical Operations and Medical teams, play a key role in drafting protocols/strategies for clinical studies, helping advancing business development efforts and supporting execution of ongoing studies as lead Medical Monitor.
You will also actively partner with our Sales team to ensure we continue to maintain a scientific commercial strategy. 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.
Clinical study planning and execution
- Development of protocol concepts, protocols and clinical development plans for biotech clients
- Medical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy considerations
- Medical monitoring and oversight of phase 2-4 trials
- Provide clinical trial design consulting services to biotech clients
- Review of potential client pipelines to develop scientific and data-driven commercial strategies
- Direct participation in introductory client calls and bid defenses
- Help identify potential opportunities based on client pipelines/scientific advances
- Drive/contribute to trial operations and medical processes to achieve continued innovation and improvement
- Support the training and engagement of our Investigator network
- 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
- Clinical training for internal stakeholders e.g. overviews of specific disease areas, drug mechanisms of action, etc.
- Input into patient recruitment tools
- Ideas for recruitment strategies - i.e. creative ideas for where we can find patients
Network engagement (TrialSpark’s network of PIs and SubIs
- Network investigator conversations (e.g. questions / concerns about a protocol)
- Physician marketing / recruitment support
- Identifying targets and strategies for Network growth
- Participating in meetings with new physician groups and health systems
- Physician engagement support - e.g. helping to build/support therapeutic area advisory boards
Education and Experience
- 5+ years biopharma industry experience
- 5+ years experience in protocol development and medical oversight/monitoring of phase 2-4 studies
- MD/DO required (Internal Medicine preferred)
Skills, abilities, and knowledge
- A demonstrated ability to plan and lead teams in executing complex global clinical trials.
- Thorough knowledge and understanding of clinical research concepts, practices, and regulations.
- Critical thinker with ability to step back and rethink legacy assumptions in the clinical research space; should be able to point to what’s wrong, and how you would do it differently if starting from scratch.
- Excellent cross-functional partnership skills; you know how to work across an organization to achieve objectives and meet timelines.
- Solid written and oral communication skills; can synthesize complex concepts and deliver messages clearly.
- Competency with data analysis: should have intermediate+ ability with Excel, and fluency with managing to metrics and key performance indicators.
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.