Physician Project Leader - Cell Therapy (NY ESO 1)
As the Physician Project Leader – Cell Therapy (NY ESO 1), you will be a global, visionary leader with an entrepreneurial mindset with a passion for developing and leading others. You will lead all aspects and the global development program for a mid-stage cell and gene therapy (NY ESO 1). You will lead the global Clinical Matrix Team (CMT) and be the an integral member of the Global Medicines Development Team within the GSK Cell and Gene Therapy group. This is a key leadership position and is accountable for managing all medical and clinical aspects for NY ESO 1 cell therapy towards initial approval and lifecycle management.
In this role, you will be working in a multi-functional drug development team, collaborating closely with internal and external scientists, statisticians, and other key stakeholders in both the development and the discovery / translational-medicine groups. You will also be developing, engaging, leading, and directly managing a team of physicians and clinical scientists who will be accountable for one or more clinical studies.
· Clinical Oncology Development Leadership, Disease Area Expertise, and Prescriber Insight as single point of accountability for end to end Clinical Development Plan.
· Identify opportunities to drive product strategy and key Medical Governance reviews.
· Manage the risk-benefit of the global program and all areas of clinical development investigation, and collaborating closely with the accountable Pharmacovigilance and safety teams.
· Prepare, design, and/or review clinical, regulatory and other key documents (e.g. protocols, investigator’s brochures, electronic case report form design).
· Lead the interpretation clinical trial data results and develop clinical trial reports.
· Lead the preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.).
· Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) or directly with study investigators.
· Participate in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits.
· Review safety data for routine medical data review, trend review, and safety signals from ongoing trials.
· Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources.
· Contribute to the global scientific literature by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
· Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards).
· Develop and manage relationships with key opinion leaders for clinical programs.
Qualifications, Experience, and Skills:
- M.D. or M.D./Ph.D. with Board certification/eligibility, and clinical experience in oncology or hematology/oncology and drug development. Experience in Cell and Gene Therapies.
- At least five years' pharmaceutical or relevant scientific/medical/clinical experience.
- Experience in designing and delivering development strategies and clinical trial designs (preferably pivotal programs in oncology) that have led to medicine approvals.
- Scientific acumen and experience demonstrating an understanding of translational medicine and companion diagnostics strategies in oncology.
- Ability to work cross-functionally while applying creative problem-solving skills.
- Excellent strategic planning, organizational and communication skills.
- Managerial experience working within or leading high-performance, cross-functional matrix teams.
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