SciPro is currently partner with a biotech company based in San Diego & Boston that's developing innovative therapies that target overlooked regions of the genome known to influence disease. Using a proprietary platform, the company identifies and targets specific RNA molecules involved in controlling how cells behave, especially in chronic conditions like heart failure. Their approach aims to create precise treatments with fewer side effects by focusing on non-coding RNA elements unique to certain tissues or disease states.
We're searching for a Medical Director to drive the development of a novel RNA-targeted therapy for hypertrophic cardiomyopathy (HCM). This strategic role will oversee the execution of clinical programs for the company's lead therapeutic candidate to address key drivers of HCM. The position involves leading early-stage clinical trials, shaping trial designs, and collaborating across internal teams and external stakeholders.
This role offers a unique chance to help build a clinical development function from the ground up within an innovative biotech setting. As the first leader in this area, you'll work closely with senior leadership to define the strategic direction while overseeing the rollout of clinical programs for a key therapeutic candidate in cardiovascular health.
This is a hybrid position at either their San Diego or Boston office. Relocation assistance is available.
Therapeutic Area & Leadership:
- Lead the clinical strategy for RNA-based therapeutics focused on heart diseases, specifically genetic heart conditions like hypertrophic cardiomyopathy (HCM).
- Drive the integration of advanced RNA science into clinical development, collaborating with RNA specialists, biomarker discovery teams, and patient stratification efforts to develop personalized treatments for heart disease.
- Work closely with cross-functional teams to ensure the clinical program aligns with the company's broader goals, advancing the RNA therapeutics pipeline for heart conditions.
Clinical Development & Medical Oversight:
- Guide the design of clinical trials, contributing to protocol development and ensuring precision RNA approaches are central to trial design, endpoints, and methodologies.
- Serve as the lead medical expert and monitor for early-phase studies, including first-in-human trials, ensuring thorough safety and efficacy evaluations of RNA therapeutics.
- Collaborate on the development of biomarkers and other technologies for monitoring disease progression and therapeutic response, including RNA-based and genomic tools.
- Ensure that clinical trial submissions comply with regulatory standards and guidelines, including FDA, EMA, and ICH, providing medical oversight for regulatory filings.
Cross-Functional Leadership & Collaboration:
- Partner with internal teams, including preclinical, clinical operations, biomarker discovery, and regulatory affairs, to ensure alignment with company-wide strategies.
- Provide thought leadership in RNA therapeutics, participating in advisory boards, steering committees, and safety monitoring groups.
- Collaborate with external experts and key opinion leaders to validate clinical strategies and maintain high scientific standards.
- Stay up-to-date with scientific literature on RNA therapeutics and heart disease, sharing insights across the organization to guide development activities.
Regulatory Strategy & Clinical Documentation:
- Contribute to regulatory strategies, ensuring alignment with global regulatory agencies, including the FDA and EMA, for RNA-based therapies.
- Support the preparation and review of regulatory documents and trial submissions, including clinical trial applications and filings for RNA-targeting treatments.
Education & Experience:
- MD or MD/PhD in cardiovascular medicine, RNA therapeutics, or a related field.
- At least 10 years of experience in translational science in cardiovascular therapeutics, with expertise in genetic heart diseases.
- Proven track record in leading clinical development programs, particularly in genetic medicines or RNA-based drug discovery.
- Board certification or significant experience in cardiovascular diseases, advanced heart failure, or genetic cardiomyopathies is highly desirable.