The Senior Director, Clinical Research and Development role is a clinical individual contributor position in the Immunoglobulins Therapeutic Area (TA). You will be responsible for translation of the TA strategy into a clinical development strategy and for the delivery of clinical program according to the global product strategy and clinical development plan.

This is an essential matrix leadership role, providing strategic, clinical, and medical leadership to assigned clinical development program(s) or individual clinical trial(s) from conceptualization through execution. As a medical subject matter expert in the Immunoglobulins therapeutic area, functions as the clinical representative on Clinical Development Team(s) (CDT) and/or on Project Strategic Teams(s) (PST), as assigned.

Responsible for creating clinical development strategies and delivery plans for investigational and/or marketed products according to the Therapeutic Area- and global Product strategy.

You are the author and/or key contributor to program and study level documents and educational materials for internal and external trainings in alignment with the scientific/medical strategy; key contributor to the CSR and external presentations and/or manuscripts, supports appropriate scientific and medical interpretation and communication of clinical trial data; authoring study reports and as SME makes substantial contributions to regulatory dossiers , including briefing documents, submission summary documents (SCE, SCS, CO) and responses to Health Authority questions.

Role and Responsibilities

• You are responsible for identifying potential challenges, risks and roadblocks associated with the global clinical development strategy and/or its execution.
• You act as a leader and subject matter expert in developing solutions to address these, working cross-functionally with key stakeholders and matrix team members.
• You serve as a senior medical representative on the cross-functional clinical development and/or product strategy teams as assigned; responsible for presenting study data and program strategic plans to internal governance committees for endorsement and key program milestones;
• You support product label development and maintenance, provides product/program specific input for target product profile(s),
• You are responsible for delivery of clinical programs by providing scientific and clinical development expertise for the safe, efficient, and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs.
• You are accountable for global medical oversight of selected product(s) within the assigned therapeutic area(s) and responsible for defining and implementing medical monitoring and oversight strategy for individual clinical studies to ensure the highest level of patient safety and data integrity, including ongoing review of blinded data.
• You interface with key high-level internal and external stakeholders.
• You represent the company as the scientific subject matter expert at external meetings including those with Regulatory Agencies, Investigators, Steering Committees, Advisory Groups.
• You supervise activities of Clinical Scientists and Medical Directors in the execution of clinical studies and contribute to multidisciplinary working groups to support continuous process improvement as requested.
• You maintain awareness of scientific developments within area of expertise, including new scientific findings and research methodologies.

Background education and Experience

• MD (Medical Doctor degree) or international equivalent from a recognized school of medicine plus accredited residency.
• Eligibility for medical licensure and board certification desirable.
• PhD or board certification in oncology, hematology preferred.
• Specialty training in Pharmaceutical Medicine is a plus.
• Two (2) years minimum experience as a physician in patient care.
• 5 + years pharmaceutical / biotechnology industry experience, of which significant experience and accountability for Phase 2b/3 clinical development programs.
• Extensive knowledge of the drug development process and clinical research methodologies including substantial experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of global and regional regulations, ICH/GCP, adverse event management.
• Ability to adapt late-stage prospective clinical trial design principles into a retrospective / real world study including identification of potential operational factors that contribute to confounding / bias in the interpretation of the real-world data.
• Demonstrated experience and accountability for global regulatory submissions (e.g., NDA, BLA, MAA)
• Experience in addressing and managing complex medical issues in the pre-approval and post-approval environment.
• Track record of medical credibility and excellence - achievement in pharmaceutical development, ability to coordinate and execute clinical development.
• Demonstrated record of scientific scholarship and achievement, including successful authorship of peer-reviewed scientific publications.

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