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MENARINI Group · 2 months ago

Senior Director, Clinical Scientist, Solid Tumor

Full-time

Hybrid

Director/Executive

$245K/yr - $295K/yr

8+ years exp

MENARINI Group is an established Italian pharmaceutical company with a strong focus on oncology. They are seeking a Senior Director, Clinical Scientist to provide scientific expertise for clinical studies, ensuring data integrity and leading a cross-functional team in the development of innovative oncology therapeutics.

BiotechnologyMedicalPharmaceutical

Responsibilities

Perform clinical/medical data review, analysis, and interpretation of study results, ensuring accurate data reporting

Identify study issues by monitoring emerging clinical data related to safety, efficacy, and PK/PD

Design and execute clinical data review plans in collaboration with cross-functional teams, including evaluating specific data trends and performing manual coding of adverse events and concomitant medications as needed

Ensure processes and procedures are in place for clinical safety monitoring and patient safety

Work closely with the Medical Monitor to keep them informed of pertinent study information, including safety and efficacy data

Contribute to the authoring of clinical study protocols and Informed Consent Forms (ICFs)/amendments

Review and draft a variety of study and regulatory documents such as Briefing Books, Investigator Brochures (IB), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions (e.g., IND, annual reports)

Maintain appropriate clinical documentation and submit clinical documents to the Trial Master File (TMF)

Ensure prompt, quality responses to IRBs/ERCs, IDMCs, etc

Collaborate and liaise with external partners (e.g., Key Opinion Leaders/KOLs) in various settings (1:1 meetings, investigator meetings)

In conjunction with the Medical Director, establish and oversee the management of study committees (e.g., Steering Committee, IDMC)

Serve as the Clinical Science Representative on assigned cross-functional teams

Provide regular and timely updates to management regarding study activities and data status

Anticipate study-related activities or barriers and present potential resolutions to leadership

Develop and present site and CRA training materials at Site Initiation Visits (SIVs) and Investigator Meetings

Develop presentations and communicate study data results internally and externally to investigators and at scientific conferences/symposia (abstracts, posters, publications)

Conduct literature reviews to interpret study data, inform next steps, and maintain current knowledge of the external scientific environment

Ensure Case Report Form (CRF) design adequately supports data collection in alignment with the protocol, collaborating with Data Management/Programming and potentially participating in User Acceptance Testing (UAT)

May lead or support trial-level activities for one or more trials with necessary supervision

Qualification

Clinical Data ManagementOncology ExpertiseRegulatory SubmissionsEDC SystemsGCP KnowledgeTrainingCollaborationCommunicationPresentation Skills

Required

8+ years' experience in drug development as a clinical scientist or related role in pharmaceutical/biotech industry

Advanced degree (e.g. MS, PharmD., PhD) or equivalent experience is required

Experience in late phase solid tumor oncology is required

Proficient with Microsoft Word/Excel/PowerPoint, EDC systems (e.g. Medidata RAVE), and data review tools (e.g., patient profiles, report generating tools)

Knowledge of GCP, ICH Guidelines and current US FDA regulations

Willingness to work Eastern Time Zone (US) hours