Director, Clinical Science

3 weeks ago

Charlestown, United States Solid Biosciences Full time

Job Title:

Director, Clinical Science

Reports to (title):

Senior Director, Clinical Science

Summary:

Solid Biotechnology is seeking a Director, Clinical Science to aid in the development of clinical strategy and lead the execution of clinical development. Clinical Scientist resides within Clinical Development and reports either to head of clinical science, CMO or delegate.

The role undertakes comprehensive assessment and execution of clinical development of key programs within specific therapeutic areas. The Clinician will partner with the Therapeutic Area Head on overall strategy and execution of clinical development. Specifically, the Clinician is responsible for: in depth assessment of target diseases, to participation in the conception and implementation of a clinical development strategy, to partner with and take strategic direction from Therapeutic Area Head in the development of novel assets, to act as the clinical lead in clinical stage assets, to partner with clinical operational leads in the development and implementation of the clinical trial protocol, to engage with a multifunctional clinical team in key translational or clinical activities (depending on the stage of the asset), and to represent the enterprise to external stakeholders (key opinion leaders, investigators, scientific collaborators). The Clinician will be strategically minded, with translational medicine and early clinical development expertise to prosecute the development of clinical programs. The Medical Clinician will lead the conduct of early and late-stage clinical trials, assess clinical safety and efficacy data, and author aspects of the clinical study reports, clinical sections of INDs, Investigator Brochures, and other clinical documents.

Other responsibilities include interpreting reports, preparing oral and written results of research, and participate in strategic discussions across different clinical programs.

Key Duties & Accountabilities:

* Partner with clinical operations lead on clinical stage assets to ensure the execution of clinical trial milestones
* Act as the clinical lead on clinical projects (clinical stage assets) to build consensus around key decisions pertaining to all aspects of the clinical trial planning and execution
* Represent the clinical aspects of the trials and status of clinical stage assets to management
* Partner closely with program management around cross functional inputs a clinical stage asset along it's development lifecycle (translation through registration)
* Facilitate the creation of comprehensive clinical development plans that are innovative, safe and create foundation for decision making and are aligned with therapeutic area disease
* Participate in the development of Target Product Profile (TPP) including elicitation of subject matter expertise from KOLs
* Engage key external collaborations to further the overall development of the therapeutic area clinical development
* Develop protocol synopses and assist the clinical operations leads with the development of the clinical trial protocol
* Ensure that all safety and efficacy data acquisition is fit for purpose and registration ready (as appropriate)
* Assist in medical monitoring duties as required and appropriate
* Contribute to the development of the 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
* Partner closely with research group leaders, drug discovery teams, bioanalytical and translational development teams, project and clinical operations teams

Competencies Required:

* 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

Knowledge: Education, Experience, & Skills:

* Advanced medical degree (MS, PhD)
* Minimum 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

Travel Commitment:

* Occasional Travel
* Availability for no less than 5 hours per day during Eastern Standard time 8am to 5pm

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