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Medical Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Senior Medical Director, Clinical Development Company: Spero Therapeutics

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Senior Medical Director, Clinical Development The Senior MedicalDirector will report to the Vice-President of Clinical Development.This individual will have cross-project responsibility for thedesign and delivery of assigned Phase 1 to Phase 3 clinical studieswithin the SPR994, SPR720, and SPR206 clinical developmentprograms. She/he will assist the Project Team with the design ofinnovative and efficient Clinical Development Plans. Incollaboration with Clinical Pharmacology and Clinical Operations,this individual will design clinical study protocols, monitorongoing clinical studies, review and interpret clinical trial data,and author clinical study and regulatory communications anddocuments. It is expected that the Senior Medical Director willpresent clinical study results at scientific meetings, authorpublications, and support interactions with regulatory authoritiesrelevant to her/his assigned projects.

Responsibilities

Develop novel clinical trial designs to assess the safety andefficacy of candidate drugs in small populations of patients withinfectious or inflammatory diseases.

Provide relevant treatment area expertise and strategic insightto identify additional development opportunities

Assist the Project Team Lead(s) to generate creative, efficient,and feasible Target Product Profiles and Clinical Development Plansthat incorporate a clear line of site to NDA submission andapproval, launch, and commercialization for novel agents targetingrare diseases.

Assist the Regulatory Affairs Lead to design and attain FDA andEMA approval of novel pathways for approval for agents targetingrare 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 thedevelopment of surrogate markers to assess target engagement andclinical effect.

Support the clinical pharmacology function in the assessment ofPK-PD modeling and dose escalation in Phase 1, and in the selectionof doses for Phase 2 and 3 studies.

Coordinate with clinical operations and the relevant functionalleads to ensure delivery of projects to time and budget

Medical monitoring, coding, and data cleaning in collaborationwith Clinical Operations

Author clinical sections in regulatory documents including INDand NDA submissions, annual updates, study protocols, investigatorbrochures, briefing documents, and other study-relevant documentssuch as patient informed consent documents

Writing manuscripts, publications, or other documents intendedfor external audiences

Act as an internal resource for functions requiring clinicalinput on the select drug(s) including primary point of contact forclinical trial staff at study sites for clinical issues as well asregulatory, safety and other functions

Prepare safety charters, DMC charters, or other specificmanagement plans and manuals in a cross-functional team

Support the preparation of and data interpretation and clinicaltrial reports

Preparing Investigator Alert letters and SAE reports incollaboration with Clinical Operations as required

Contribute in an active and ongoing manner to the scientific,clinical, and commercial development of current and future productcandidates

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 apostdoctoral fellowship in a relevant specialty (infectiousdiseases, rheumatology, pulmonology)

8+ years of work experience in an academic or industrial settingrelated to the discovery and development of novel pharmaceuticalagents.

Experience initiating and managing or participating in clinicaltrials for industry

Successful academic research publication history or history ofmedical practice in a relevant field

Experience presenting medical data and concepts to a variety ofaudiences (medical, scientific, vendors) in a credible and engagingmanner

Solid understanding of the clinical landscape relevant topatients and health care practitioners in the field

Strong technical/analytical skills to identify and solveproblems

Self-motivated, assertive, and self-confident with the abilityto act with urgency and passion

Proven ability to work with a high level of integrity, accuracy,and attention to detail

Ability to make thoughtful, integrated, timely and meaningfuldecisions and take corresponding actions

Willingness to work collaboratively by incorporating diverseperspectives and appropriately managing relationships

Proactively seek out and recommend process improvements

Entrepreneurial, enjoys working in a fast-paced, small-companyenvironment

Demonstrated application of critical thinking skills

Proven ability to multitask, prioritize and execute corporateobjectives and goals

Ability to operate autonomously in a fast-paced early phasecompany

What's your citizenship / employment eligibility? *

Keywords: Spero Therapeutics, Cambridge , Senior Medical Director, Clinical Development, Other , Cambridge, Massachusetts

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