Global Development Medical Director, Cell Therapy Oncology

About the role

The Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working collaboratively and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.

Responsibilities

• Evaluate the risk-benefit of a clinical study.
• Ensure all clinical studies follow rigorous ethical and safety principles.
• Follow FDA, EMEA, ICH, and GCP guidelines, as well as SOPs related to safety.
• Work with clinical product teams (CPT) to develop the study concept document, protocol, and related documents.
• Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results, and inform recruitment strategies.
• Accountable for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans (including, but not limited to, the ICF, CRF, TFL Shells, and Safety Reports).
• Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols.
• Contribute to technical review of protocols with governance bodies such as DRC and PRC.
• Contribute to the development of Medical Oversight Plan (MOP), study level safety reviews, and study-level medical monitoring activities.
• CORE member of the GST representing Clinical Development.
• Clinical input into Feasibility Questionnaires and consulted on country and site selection.
• Affirm oversight of collected data, monitoring safety and efficacy within a study.
• Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.
• Proactively engage with MSLs to build strong partnerships with SMMs and KEEs to provide robust feasibility assessments and streamline study execution.
• Contribute to development and delivery of investigator and monitor training and the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions seeking Go/No Go decisions.
• Development and delivery of the clinical study report.
• Work cross functionally in the preparation of launch & branding materials and publications.
• Where appropriate, serve as a mentor of less experienced staff.

Requirements

• MD./Ph.D. degree or equivalent with industry or academic experience in drug development.
• Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
• Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
• Ability to grow and maintain a high level of expertise in oncology therapeutic area.
• Strong preference for individuals with clinical training in oncology.

Pay

The annual base pay for this position ranges from $249,827.20 - $374,740.80.

Schedule

Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.