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ModeX Therapeutics Inc · 1 month ago

Associate Director / Director, Clinical Science & Development

Weston, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$180K/yr - $210K/yr

7+ years exp

ModeX Therapeutics Inc is seeking an Associate Director / Director of Clinical Science & Development to be a key member of project, research, and clinical development teams. This role will drive clinical development results for oncology, immune impairment, infectious diseases, and cell therapy programs, requiring collaboration across various functions and strong leadership skills.

BiotechnologyManufacturing

Responsibilities

Support Program Lead and Medical Monitor with program strategy and execution, and target product profile in line with the early development program, commercial strategy and regulatory needs

In collaboration with Program Lead, prepare presentations to obtain endorsement of the clinical strategic plan with the appropriate governance committees

Support liaison with different functions with expertise and leadership (data management, biostatistics, medical writing, pharmacovigilance, regulatory, clinical operations, translational medicine) as well as interact with and support Program team members and project management

Support the preparation of key clinical documents to be prepared for clinical trials (protocols, amendments, benefit risk assessments), interactions with internal governance bodies, external partners, key opinion leaders, investigators

Build and maintain a strong network of external vendors

Support authoring briefing packages for submission to health authorities, and work in collaboration with regulatory product manager to devise strategy for path to regulatory approval and interactions with health authorities

Maintain deep scientific, technical, and clinical expertise in immuno-oncology drug development

Partner with internal competitive intelligence SME to evaluate relevant literature, data and the status from competitive products; provide clinical landscape and benchmark updates to Program Lead

Support clinical reviews of data listings, patient profiles, and essential study data within statistical reports and partner with Medical Monitoring and Data Management/Operations in generating relevant queries

Support and/or generate in-house tables/listing and figures to facilitate internal discussions

Qualification

Clinical development expertiseOncology knowledgeRegulatory interactionsData analysis principlesClinical trial executionLeadership skillsCommunication skillsProblem-solving skillsInterpersonal skillsPresentation skills

Required

Advanced degree (MS, RN, or MBA; PhD scientist and Biomedical Science master is a plus)

7-10+ years of relevant professional experience, including 5+ years of industry experience required; industry experience should include both research and clinical development

Proficient in clinical literatures and critical interpretation of clinical study results

Experience with supporting preparation and execution of clinical trials

Strong scientific and academic background in oncology, including translational science and tumor biology

Strategic thinking in combination with understanding of up-to-date science and technologies to support to clinical development

Experience with basic principles of data analysis, interpretation and clinical relevance

Experience in successful collaboration with and leading cross-functional activities with interdisciplinary professionals

Ability to interact and effectively communicate with all levels of personnel within the organization and with clients of the Sponsor company (i.e., vendors and CROs)

Strong leadership, interpersonal, communication, and presentation skills

Outstanding communicator, excellent problem-solving, conflict-resolution and decision-making skills

Driven individual and performance oriented with ability to work along agreed timelines

Proven ability to manage projects/team of significant scope and complexity, while meeting all deliverables and timelines