Solid Biosciences
Overview
Job Title: Vice President, Head of Clinical R&D (HoC)
Reports to (title): CMO
The HoC works 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.
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.
Knowledge : Education, Experience, & Skills
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.
Travel Commitment This role should have an expectation of 20% travel and may require significant travel on an ad hoc basis.
Local to Boston / Charlestown MA strongly preferred
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Reports to (title): CMO
The HoC works 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.
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.
Knowledge : Education, Experience, & Skills
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.
Travel Commitment This role should have an expectation of 20% travel and may require significant travel on an ad hoc basis.
Local to Boston / Charlestown MA strongly preferred
#J-18808-Ljbffr