Job Description:

• The Senior Medical Director will report to the Vice-President of Clinical Development.
• This individual will have cross-project responsibility for the design and delivery of assigned Phase 1 to Phase 3 clinical studies within the SPR994, SPR720, and SPR206 clinical development programs.
• She/he will assist the Project Team with the design of innovative and efficient Clinical Development Plans.
• In collaboration with Clinical Pharmacology and Clinical Operations, this individual will design clinical study protocols, monitor ongoing clinical studies, review and interpret clinical trial data, and author clinical study and regulatory communications and documents.
• It is expected that the Senior Medical Director will present clinical study results at scientific meetings, author publications, and support interactions with regulatory authorities relevant to her/his assigned projects.

Responsibilities:

• Develop novel clinical trial designs to assess the safety and efficacy of candidate drugs in small populations of patients with infectious or inflammatory diseases.
• Provide relevant treatment area expertise and strategic insight to identify additional development opportunities
• Assist the Project Team Lead(s) to generate creative, efficient, and feasible
• Target Product Profiles and Clinical Development Plans that incorporate a clear line of site to NDA submission and approval, launch, and commercialization for novel agents targeting rare diseases.
• Assist the Regulatory Affairs Lead to design and attain FDA and EMA approval of novel pathways for approval for agents targeting rare disease given that guidance for such pathways may not exist.
• Provide clinical support for informal and formal meetings with FDA, EMA, and other national agencies.
• Support the biology and microbiology functions in the development of surrogate markers to assess target engagement and clinical effect.
• Support the clinical pharmacology function in the assessment of PK-PD modeling and dose escalation in Phase 1, and in the selection of doses for Phase 2 and 3 studies.
• Coordinate with clinical operations and the relevant functional leads to ensure delivery of projects to time and budgetMedical monitoring, coding, and data cleaning in collaboration with Clinical Operations
• Author clinical sections in regulatory documents including IND and NDA submissions, annual updates, study protocols, investigator brochures, briefing documents, and other study-relevant documents such as patient informed consent documentsWriting manuscripts, publications, or other documents intended for external audiences
• Act as an internal resource for functions requiring clinical input on the select drug(s) including primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functionsPrepare safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team
• Support the preparation of and data interpretation and clinical trial reports
• Preparing Investigator Alert letters and SAE reports in collaboration with Clinical Operations as required
• Contribute in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates
• Contribute to Strategic or Clinical Advisory Boards and, Supporting Medical Affairs as needed

Qualifications And Experience:

• M.D. degree and completion of Residency training and a postdoctoral fellowship in a relevant specialty (infectious diseases, rheumatology, pulmonology)
• 8+ years of work experience in an academic or industrial setting related to the discovery and development of novel pharmaceutical agents.
• Experience initiating and managing or participating in clinical trials for industry
• Successful academic research publication history or history of medical practice in a relevant fieldExperience presenting medical data and concepts to a variety of audiences (medical, scientific, vendors) in a credible and engaging manner
• Solid understanding of the clinical landscape relevant to patients and health care practitioners in the field
• Strong technical/analytical skills to identify and solve problems
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
• Proven ability to work with a high level of integrity, accuracy, and attention to detailAbility to make thoughtful, integrated, timely and meaningful decisions and take corresponding actionsWillingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships
• Proactively seek out and recommend process improvements
• Entrepreneurial, enjoys working in a fast-paced, small-company environment
• Demonstrated application of critical thinking skillsProven ability to multitask, prioritize and execute corporate objectives and goals
• Ability to operate autonomously in a fast-paced early phase company

Key Skills: