What are the responsibilities and job description for the Associate Medical Director, Clinical Development position at Solid Biosciences?

Job Description

Solid Summary :

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated next generation gene therapy candidate for the treatment of Duchenne, SGT-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, SGT-501, a gene therapy program for the treatment of catecholaminergic polymorphic ventricular tachycardia, and additional assets for the treatment of fatal cardiac and neurologic disease. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and clinical 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 an Associate Medical Director of Clinical Development to lead clinical strategy and execution of clinical development. The Associate Medical Director resides in the Clinical R&D and reports the Head of Clinical Development or delegate (such as Therapeutic Area Head).

The Associate Medical Director of Clinical Development (AMD-CD) oversees the assessment and execution of clinical development of one or more programs in collaboration with the Head of Clinical Development or Therapeutic Area Head (TAH). This role will be primarily responsible for the SGT-003 next generation gene therapy for Duchenne Muscular Dystrophy clinical trial execution, analysis and strategy. The AMD-CD is responsible for : in depth assessment of key diseases, therapeutic opportunities, genesis and or refinement of clinical development strategy, partnering with internal or external Subject Matter Experts (SME) to assess novel assets, to work in partnership with clinical scientists on clinical study designs, to provide clinical oversight to the multifunctional preclinical and clinical teams, and to represent the enterprise as the face and contact for external stakeholders (key opinion leaders, investigators, scientific collaborators). The AMD-CD will ultimately be accountable for assisting in developing the strategy of asset development, the execution and clinical conduct of early and late-stage clinical trials, assessing clinical safety and efficacy data, and to contributing to the writing of clinical study reports, clinical sections of INDs, Investigator Brochures, and other clinical documents.

The AMD-CD 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 :

To partner with the Head of Clinical development or Therapeutic Area Head in the development of clinical strategy for specific assets and their associated diseases
To assist in the development or refinement of clinical development plans that are innovative, safe and create foundation for decision making and are aligned with therapeutic area disease
Provide medical input and clinical strategy into the development of the Target Product Profile (TPP)
Identify key external collaborations to further the overall development of the therapeutic area clinical development
Provide guidance and expertise in the development of protocol synopsis and clinical trial protocol in partnership with clinical sciences
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
Partner closely with research group leaders, drug discovery teams, bioanalytical and translational development teams, project and clinical operations teams
Liaise with Clinical Operations to deliver therapeutic area clinical study program goals and milestones

Basic Qualifications :

Excellent judgment and ability to resolve complex issues effectively

Advanced medical degree (MD, MD PhD, PharmD), or equivalent

Expertise in rare diseases / neuromuscular diseases / cardiovascular (regenerative / molecular genetic / gene therapy is a plus but not required)

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

Years of Experience :

5 years

Preferred Qualifications :

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

5 years of clinical research or clinical development experience in pharmaceutical / biotechnological industry ideally across all phases of clinical trialsExtensive 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)

Travel Commitment :

Occasional Travel – 20% (Mostly in Europe)

Report to Charlestown campus no less than once a quarter (Preferred)

Location on the East Coast.

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Associate Medical Director, Clinical Development

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