Associate Director, Clinical Sciences

Jobtailor

Upper Providence (Delaware County)

On-site

USD 150,000 - 190,000

Full time

14 days+

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Job summary

Jobtailor is seeking a clinical sciences leader to spearhead global oncology studies and drive study strategy from concept to final report. You will own protocols, lead safety reviews, and ensure ICH/GCP compliance while coordinating with investigators, CROs, and vendors.

We value senior-level expertise in immuno-oncology, cross-functional leadership, and clear communication to influence regulatory submissions and safety monitoring across all study phases.

Qualifications

Bachelor’s degree in life sciences or related discipline.
3+ years of experience in pharmaceutical/biotechnology industry or related clinical experience.
Experience in a pharma/CRO environment in the clinical development process.
Oncology clinical development experience, particularly immuno-oncology.
Experience with study management, regulatory guidelines, and ICH/GCP.
Experience writing study protocols, procedures manuals, informed consent forms, and clinical study reports.
Experience working with investigators, site staff, CROs, vendors.
Advanced degree (MS, PharmD, PhD) preferred.
Clinical development experience across all phases I-IV preferred.
Strong communication, influencing, and leadership skills.

Responsibilities

Serve as a clinical sciences leader on global oncology studies and contribute to program-level activities.
Lead delivery of study strategy and design and understand analysis and interpretation of data throughout study conduct.
Lead ongoing clinical data review and medical review of clinical trial data.
Own end-to-end writing of protocols from protocol concept through final study report.
Contribute to informed consent forms and other study-related documents.
Review and enhance project-level clinical development plans.
Support regulatory interactions, briefing documents, presentations, questions, and responses.
Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and GSK SOPs.
Contribute to end-to-end clinical development strategy.
Review and monitor safety data with pharmacovigilance.
Participate in blinded review of data packages for IDMCs.
Make risk/benefit decisions and take actions to mitigate risks.
Collaborate with oncology staff across global functions and cultivate relationships among study teams.
Provide training, onboarding, and problem-solving support for clinical trials.
Provide study-level leadership and accountability for safety and regulatory reporting.
Drive or contribute to clinical components of investigator brochures and regulatory submission documents.
Serve as a product, protocol, and project subject matter expert.
Work with external experts to develop abstracts, manuscripts, and study design presentations.

Skills

Study Management

Clinical Study Reports

Informed Consent Forms

Clinical Development Strategy

Pharmacovigilance

Data Analysis

Study Procedures Manuals

Risk/Benefit Decision Making

Global Regulatory Guidelines

Clinical Development Phases I-IV

Communication Skills

Influencing Skills

Negotiation Skills

Leadership Skills

Problem-Solving Support

Education

Bachelor’s Degree in Life Sciences

Advanced Degree Preferred (MS, PharmD, PhD)

Job description

Serve as a clinical sciences leader on global oncology studies and contribute to program-level activities
Lead delivery of study strategy and design and understand analysis and interpretation of data throughout study conduct
Lead ongoing clinical data review and medical review of clinical trial data
Own end-to-end writing of protocols from protocol concept through final study report
Contribute to informed consent forms and other study-related documents
Review and enhance project-level clinical development plans
Support regulatory interactions, briefing documents, presentations, questions, and responses
Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and GSK SOPs
Contribute to end-to-end clinical development strategy
Review and monitor safety data with pharmacovigilance
Participate in blinded review of data packages for IDMCs
Make risk/benefit decisions and take actions to mitigate risks
Collaborate with oncology staff across global functions and cultivate relationships among study/project teams
Provide training, education, onboarding, and problem-solving support for clinical trials
Provide study-level leadership and accountability for safety and regulatory reporting
Drive or contribute to clinical components of investigator brochures and regulatory submission documents
Serve as a product, protocol, and project subject matter expert
Work with external experts to develop abstracts, manuscripts, and study design presentations

Requirements

Bachelor’s degree in life sciences or related discipline
3+ years of experience in the pharmaceutical/biotechnology industry or related clinical experience
Experience in a pharmaceutical industry or CRO environment in the clinical development process
Oncology clinical development experience, particularly immuno-oncology
In-depth experience with study management, global regulatory guidelines, and ICH/GCP
Experience developing and writing study protocols, study procedures manuals, informed consent forms, and clinical study reports
Experience working with investigators, site staff, external experts, Contract Research Organizations, and vendors
Advanced degree (MS, PharmD, PhD) or equivalent clinical research experience is preferred
Clinical development experience across all phases of development (I-IV) is preferred
Highly developed communication skills appropriate to the target audience
Proven expertise proactively identifying issues affecting clinical programs and contributing to cross-functional solutions
Excellent influencing and negotiation skills
Excellent leadership skills

Core Competencies

Demonstrates expertise in oncology clinical development, including protocol writing, regulatory compliance, and safety data monitoring. Proven ability to lead cross-functional teams and communicate effectively with diverse stakeholders in the pharmaceutical industry.

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