Senior Director, Clinical Development: Diagnostics - Boston, United States - Scipher Medicine

Description

We are tackling one of the largest problems in healthcare. In autoimmune conditions, a common clinical practice includes trial-and-error approaches to determine the right therapy for a patient. At Scipher Medicine, we are developing an innovative portfolio of personalized medicine solutions in complex diseases. Scipher's platform identifies and guides physicians towards a more targeted approach to determine the best treatment for their patients, based on their patient's own fundamental disease biology. We have a growing pipeline of products being developed and the potential to predict which therapies patients will respond to, ensuring optimal treatment is prescribed from day one.

This includes PrismRA, a precision medicine test that helps guide healthcare providers' treatment decisions in patients with rheumatoid arthritis. Pipeline indications span the autoimmune and immune-mediated disease space.

POSITION OVERVIEW

The individual will lead and drive strategic direction for clinical utility efforts, including the design, execution, and presentation demonstrating impact of precision medicine tests in patient care and health ecosystems. These post-market analyses will align with the company's commercialized precision medicine tests in autoimmune diseases. In addition, the role will design clinical validation studies across pipeline indications spanning inflammatory bowel disease, psoriatic arthritis, and other autoimmune/immune-mediated conditions. This individual will be integral in developing the evidence package that addresses key evidence gaps and strategy for pipeline indications (e.g., clinical and economic impact, patient journey and perspective, comparative effectiveness research). Position involves the ability to independently evaluate, discuss, present, and explain material of moderate to high complexity.

RESPONSIBILITIES

· Strategic design of global data generation efforts across precision medicine test indications, including data generation efforts across product development phases

· Devise, formulate and execute investigative analyses to support continuing evidence programs for post-market clinical follow-up studies, including scope, feasibility, cost, and timing for conduct of study analyses

· Devise and formulate prospective clinical validation studies across pipeline indications.

· Work in concert with clinical operations teams executing prospective study design and draft all study related documents

· Assist as medical representative for ongoing prospective studies

· Assist the development of publication of findings at conferences and in peer-reviewed literature, in collaboration with Medical Affairs and Medical Writing team

· Lead analysis projects, including design and interpretation of clinical research and clinical utility studies

· Consult as needed in strategic design of investigator sponsored studies and other investigator initiated studies

· Act as a key intermediary and create alignment between Medical Affairs, Regulatory Affairs, Market Access, and Data Science teams, as it pertains to gap analyses and development of new analysis plans

· Gather and evaluate existing clinical evidence and gaps in information to form a foundation for decision making during analysis planning and execution

· Oversee review and cataloguing of documents related to analysis plan designs, study synopses, technical files, and literature to ensure robust planning

· Maintain expert knowledge of products, disease indication and regulatory standards

· Work proactively and collaboratively with external and internal stakeholders and vendors to achieve research objectives

QUALIFICATIONS

· Advanced degree (PhD, PharmD, MD) in a relevant scientific/clinical/medical field.

· Preference given to candidates with past experiences in rheumatology and gastroenterology experience in therapeutics and/or devices

· 3+ years of postdoc or prior industry clinical development research and leadership experience preferred

· Prior experience with human subject research required

· Excellent project management, communication, and cross functional relationship building skills

· Demonstrated strength in communication and relaying technical information accurately and concisely

· Leadership experience at level of managing multiple projects with competing deadlines and priorities

· History or strong understanding of working in a start-up environment

· Ability to manage a team and prioritize efforts with competing resources efficiently

Scipher is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religions, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status or any other characteristic protected by law.