- Lead the development of clinical strategy for specific assets and their associated diseases
- Develop, create and implement comprehensive clinical development plans that are innovative, safe and create foundation for decision making and are aligned with therapeutic area disease
- Provide medical input into the development of Target Product Profile (TPP)
- Identify key external collaborations to further the overall development of the therapeutic area clinical development
- Oversee the development of protocol synopsis and clinical trial protocol
- Ensure that all safety and efficacy data acquisition is fit for purpose and registration ready (as appropriate)
- Perform medical monitoring duties as required (such as medical oversight of the study; answer questions about eligibility; review safety and adverse event data)
- Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones
- Play a key role in the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from safety and efficacy trials. Interpret data to produce strategically relevant abstracts, presentations and manuscripts
- Author (and/or work with medical writer to develop) other clinical documents like, briefing documents and other regulatory filings, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts
- Serve as medical representative with regulatory agencies
- Manage direct reports of Clinical Scientists assigned to the program
- Partner closely with research group leaders, drug discovery teams, bioanalytical and translational development teams, project and clinical operations teams
- Liaise with Head of Clinical Operations to deliver therapeutic area clinical study program goals and milestones
- Advanced medical degree (MD, MD PhD)
- Expertise in rare diseases/neuromuscular diseases/cardiovascular (regenerative/molecular genetic/gene therapy is a plus but not required)
- Minimum 2-5 years of clinical research or clinical development experience in pharmaceutical/biotechnological industry ideally across all phases of clinical trials
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy, design of study protocols, execution and analysis of clinical studies. Experience and familiarity with Good Clinical Practices (GCP)
- Experience in preparation of INDs, BLAs/NDAs and other regulatory documents
- Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors
- Strong analytical mindset, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team
- 5 years
- Excellent judgment and ability to resolve complex issues effectively
- Strong interpersonal and communication skills and experience in cultivating and managing critical relationships at all levels inside and outside of the organization.
- Exceptional attention to detail, organizational skills and judgment
- Adaptability and ability to shift with a changing biopharma landscape
- Superior verbal and written skills and ability to give well organized, thoughtful presentations to Solid management
- Occasional Travel
- Availability for no less than 5 hours per day during Eastern Standard time 8am to 5pm
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Medical Director, Therapeutic Area Head - Charlestown, United States - Solid Biosciences
1 week ago
Description
Medical Director, Therapeutic Area Head (Neuromuscular / Cardiology), Clinical DevelopmentSolid Summary:
Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich's Ataxia, and additional assets for the treatment of fatal cardiac diseases.
Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care.
Patient-focused and founded by those directly impacted, Solid's mandate is to improve the daily lives of patients living with these devastating diseases.
Position Summary:
Solid Biotechnology is seeking a Medical Director of Clinical Development, Therapeutic Area Head (TAH) to lead clinical strategy and execution of clinical development in key therapeutic areas.
The Therapeutic Area Head oversees the comprehensive assessment and execution of clinical development to multiple programs.
The TAH is responsible for:
in depth assessment of key diseases, therapeutic opportunities, genesis of clinical development strategy, partnering with management as a Subject Matter Expert (SME) to assess novel assets, directly managing clinical scientists, overseeing a multifunctional clinical team, and representing the enterprise as the face and contact for external stakeholders (key opinion leaders, investigators, scientific collaborators).
The TAH will be strategically minded, with translational medicine and early clinical development expertise developing the overall strategy for clinical programs.
The TAH will ultimately be responsible for the conduct of early and late-stage clinical trials, assess clinical safety and efficacy data, and write clinical study reports, clinical sections of INDs, Investigator Brochures, and other clinical documents.
The Therapeutic Head will work closely with clinical operations as well as biomarker, discovery, and translational research scientists.Other responsibilities include interpreting reports, preparing oral and written results of research, and participating in strategic discussions across different clinical programs.
Essential Functions / Key Responsibilities:
Basic Qualifications:
Years of Experience:
Preferred Qualifications:
Travel Commitment:
