Vice President, Head of Clinical R&D

Job Description

Job Description

Vice President, Head of Clinical R&D (HoC) – Solid Biosciences

Charlestown HQ preferred

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases.

We are seeking a Vice President, Head of Clinical R&D to work as a strategic partner with the CMO, and other members of the Executive team to provide strategic direction and technical leadership to the clinical R&D and clinical scientist groups and is responsible for the overall management, direction and performance of Phase I-IV for drug products, including: overseeing clinical development and pharmacovigilance according to agreed-upon deadlines and budgets, clinical trial design, implementation and execution, clinical research, data analysis and management. The HoC also provide strategic direction and technical leadership to the clinical R&D and clinical scientist groups in their role to guide translational development and clinical guidance and planning for Lead and IND Candidate programs as well as for evaluation, input and direction on potential partnering/business development opportunities. The HoC works in partnership with the CMO to establish the clinical research vision and regulatory roadmap for the company including standards and policies designed to ensure the quality and outcomes of compounds under development.

The HoC in collaboration with the CMO and the rest of the Executive team will have over-arching responsibility for the successful clinical development of Solid’s pipeline programs including development of a clinical roadmap for all compounds.

This role will report to the Chief Medical Officer and can be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA or work remotely from the East Coast.

Key Position Responsibilities

• Provide oversight and leadership of the various functional areas: Clinical R&D (medical directors and therapeutic area heads), clinical science, medical monitoring, pharmacovigilance

• Work collaboratively with the Research function, providing input into design of preclinical trials to support drug products from Lead through candidate phase as they enter in the clinic and including but not limited to CDP development, TPP development and IND/CTA clearance along with associated activities.
• Close collaboration with Patient Advocacy to ensure patient centricity from product conception, through clinical trial conduct into and through commercial launch and to work collaboratively to ensure the voice of the patient is represented in all decisions and actions and to ensure the voice of the physician is appropriately presented.
• Experience managing multiple programs across multiple geographies
• Input into the development of key marketing materials.
• Research and identify new opportunities and novel therapeutic opportunities that augment the company’s mission, vision, values, and goals
• Establish and maintain relationships with principal investigators and KOL’s to ensure that the Company has a clear understanding of clinician needs and requirements.
• Represent and manage communication of Solid’s clinical and regulatory programs to diverse audiences including: the executive team, regulatory agencies including the FDA and EMA, investors, Board of Directors, and other key stakeholders.
• To assist in communications with other pharmaceutical companies and partners to identify and implement collaborative studies, regulatory activities, and other programs that align with the company’s strategy and goals.
• Attract, motivate, retain and lead a highly skilled clinical development and regulatory team.
• Maintain current understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific presentations and reviewing relevant literature.
• Other related ad hoc duties and projects as required.
• Dedicated to maintaining and or adapting our clinical R&D structure and cross functional matrix relationships that empower colleagues, leverage and optimally harness their talents and maximizes their opportunities for promotion and advancement
• Dedicated to providing a dynamic working environment for mentorship and professional growth of clinical R&D colleagues.

Experience Requirements

• Board Certified MD with medical research and drug development experience.
• MD with regenerative medicine (such as AAV) preferred
• MD with experience in neuromuscular and or cardiovascular rare disease space preferred.
• Proven leader of high potential high performing teams.
• Prior experience in clinical development leadership roles (preferably global experience) across all phases of clinical studies. Demonstrated capabilities leading clinical programs to successful filing and approval in both US and globally.
• Experience interacting with the FDA/EMA and knowledge of GCP clinical requirements, general regulatory requirements, and relevant regulatory guidance documents pertinent to the Company.
• Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders. Ability to develop strong relationships with Executive team and Board of Directors.
• Able to foster and nurture a company culture grounded in science and ethics.

Key Position Attributes

This role should have an expectation of 20% travel and may require significant travel on an ad hoc basis.

Compensation

The base compensation range for this role is: $290,000 - $400,000.
Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward individual performance and align incentives to Solid’s long term company performance.

Benefits and Solid Advantages

At Solid Biosciences we offer a highly competitive total rewards and benefits package, intended to support all aspects of our employees’ lives and well-being. Additionally, for those employees working onsite at our Hood Park Headquarters, we offer a variety of onsite resources to support those working in our offices.

• Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs

• 401(k) program participation with competitive company matched contributions

• Eligibility to participate in Solid’s Employee Stock Purchase Plan

• Mobile phone subsidy for eligible employees

• Tuition Reimbursement

• Vision Coverage

• Life Insurance

• Voluntary Pet Insurance

• Employee Discount Program on Travel, Entertainment, and Services

• Employee Assistance Programs

• Daily Subsidized Lunch Delivery (onsite @ Hood Park)

• Free Onsite Full-Service Gym (onsite @ Hood Park)

• Employee Parking (onsite @ Hood Park)

• 12 Observed Holidays and a winter shut down

• 15-day PTO Policy and a 40-hour rollover YoY

• 40-hour Sick Policy

• 8 Hour Floating Holiday