Vice President, Clinical Development (Rare Disease)
Vice President, Clinical Development, Rare Disease
Arcturus is seeking an experienced physician scientist to lead drug development for our mRNA-based programs. In this role, you will have direct medical responsibility for our rare disease development programs, including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring in close collaboration with Arcturus’s internal research and platform organizations and relevant external pharmaceutical partners. Reporting to the Chief Scientific Officer, the VP will work collaboratively with other senior and functional leaders to ensure integrated development strategies, and to drive portfolio prioritization. He/she will maintain a blend of strategic and operational accountabilities and will serve as an Arcturus spokesperson in external interactions with health authorities, at scientific meetings, and working with collaborators.
Our successful candidate will thrive in a proactive, fast-paced ‘can-do’ culture and enjoy collaborating across the full range of development activities for the ground-breaking, mRNA-based new drug candidates targeting rare disease. As a technically adept and agile drug developer, the VP will play a central role in advancing and expanding the Company’s already exciting and diverse portfolio of products.
Here’s What You’ll Do:
- Provide clinical leadership for rare drug discovery and development, serve as top representative for clinical development / medical strategy areas both internal and external facing (e.g., CRO, KOL and clinical site staff) in multiple therapeutic areas.
- Lead the design clinical development plans, study protocols and interpret clinical study data, including review of the pre-clinical package.
- Lead the implementation of innovative clinical trials for novel drug candidates, from translational stage through pivotal trials and registration with adherence to cGCP and FDA Regulatory compliance.
- Serve as cross-functional leader on all medical and clinical work streams including clinical pharmacology, statistics, clinical operations, regulatory affairs, biometrics, and translational medicine.
- Provide strategic consultation and guidance to external and internal subject matter experts with regard to go/no-go development decision criteria on significant clinical components and implications.
- Apply state-of-the-art knowledge of disease mechanisms to selection of possible biomarkers, pharmacodynamic endpoints, and patient stratification considerations to support innovative clinical study designs for novel products.
- Implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues. Manage timely reporting of safety signal to regulatory authorities and the generation of clinical study reports.
- Lead clinical sections of regulatory documents (e.g., pre-IND meeting packages, IND/CTA, IB, ICF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Clinical Advisory Board meetings.
- Manage the writing of protocols, presentations, and publications (regulatory submissions, original articles, abstracts). Review documents including IBs, informed consent forms and other documentation.
- Represent the Company externally to Investigators and trial site administrators and serve as subject matter expert on all clinical and medical strategic initiatives.
- Maintain accountability for all relevant timelines and deliverables. Lead clinical team to secure global regulatory approvals for pipeline products.
- Communicate regularly and effectively with senior leaders across the R&D organization.
- Evaluate the balance between outsourcing and in-house approaches for the various Clinical Development needs, working closely with Clinical Operations to make recommendations for Arcturus’s strategy in this regard.
Here’s What You’ll Bring to the Table:
- MD or MD/PhD plus a minimum of 10 years of demonstrated experience in clinical research in rare disease as well as significant knowledge and experience in the design and execution of clinical trials.
- Demonstrated track record in leading cross-functional teams and work streams (e.g., biostatistics, regulatory, pre-clinical pharmacology and pharmaceutical sciences).
- Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills.
- Marked proficiency in clinical/medical writing.
- Understanding of the entire drug development process, including clinical and non-clinical study design and execution.
- Experience in early-stage programs.
- Experience in leading the selection and oversight of CROs and other vendors.
- Experience working with Senior Executive Team, Board members, KOLs, regulatory bodies, and investors.
- Experience overseeing activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct.
- Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States and Europe.
- Displays creative, capable and relentless problem-solving skills.
- History of taking bold, but calculated risks.
Founded in 2013 and based in San Diego, Arcturus Therapeutics Inc. is a publicly traded RNA medicines company. We are developing a portfolio of RNA therapeutics for treatment of diseases with high unmet medical needs. Our team has extensive experience in the discovery and development of RNA medicines, as well as design and utilization of lipid-mediated drug delivery systems. This combination of in-house expertise, innovative spirit, and passion for what we do, uniquely positions us to catalyze the next generation of RNA medicines. Arcturus’ commitment to the development of novel RNA therapeutics has led to partnerships with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, and the Cystic Fibrosis Foundation.
We are looking for team members with a strong dedication to the highest levels of scientific excellence. Arcturus is committed to equal opportunity and complies with all applicable national, state and local laws governing nondiscrimination in employment. Arcturus is an eVerify employer.