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(Oncology Clinical Development) Global Medical Director - Cell and Gene Therapy at GlaxoSmithKline in collegeville, Pennsylvania

Posted in Science 30+ days ago.

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Type: Full-Time

Job Description:

Would you like to be a key part of GSK's building of a world-leading organization to advance the field of Cell and Gene Therapies? If so, this is an excellent opportunity to explore.

New advances in the field of Cell and Gene Therapies (CGT) are transforming science and are unlocking a new approach to medicines development.  GSK have been involved in CGT since 2010 and is building a world-leading organization to accelerate the development of these agents for patients with cancer.   GSK are committed to rapidly progress these novel cell-based technologies, establish new development paradigms, innovative clinical trial designs, production techniques, engage with global regulatory authorities and external experts to effectively scale-up these programs and make these technologies a reality for patients with cancer.    

As the Physician Project Leader (PPL, NY-ESO-1 TCR), 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 TCR).   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 life cycle management. 

In this role, you will have a passion for solving complex problems by working in multi-functional drug development team(s) collaborating closely with internal and external scientists, statisticians, and other key stakeholders in both the development and the discovery / translational-medicine groups.

In this role you will be developing, engaging, leading and directly managing a team of physicians and clinical scientists who will be accountable for one or more clinical studies.

Key elements and Responsibilities of the role:

  • You will provide Clinical Oncology Development Leadership, Disease Area Expertise, and Prescriber Insight for NY-ESO TCR as the single point of accountability for the end to end Clinical Development Plan for NY-ESO TCR

  • You will lead, empower, engage and develop a team of physicians and clinical scientists

  • You will identify opportunities to shape product strategy and drive key Medical Governance reviews and decisions for NY-ESO TCR

  • You will be accountable for managing the risk-benefit of the global program and all areas of clinical development investigation, and collaborating closely with the accountable Pharmacovigilance and safety teams

  • You will serve as a role model and collaborate closely across all functions of the Medicines Development Team to include clinical operations, regulatory, commercial, medical affairs and other key stakeholders to deliver the strategic intent and drive value to patients and GSK .

  • You will prepare, design, and/or review clinical, regulatory and other key documents (e.g. protocols, investigator’s brochures, electronic case report form (e-CRF) design)

  • You will lead the interpretation of data analyses of clinical trial results and develop clinical trial reports

  • You will lead the preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.)

  • You will 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

  • You will participation in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits

  • You will review safety data for routine medical data review, trend review, and safety signals from ongoing trials

  • You will review adverse event (AE)/ serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with GSK safety /the CRO safety team to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs

  • You will serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources

  • You will represent GSK-Oncology at scientific meetings and presentations

  • You will contribute to the global scientific literature by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content

  • You will attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)

  • You will develop and manage relationships with key opinion leaders for clinical program


Why you?

Basic Qualifications:

  • Demonstrate expertise and clinical acumen in oncology drug development and commercialization.  

  • M.D. or M.D./Ph.D.

  • Board certification/eligibility, and clinical experience in oncology or hematology/oncology preferred

  • At least 5 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. 

  • Experience in Cell and Gene Therapies highly preferred.  Experience in oncology is required. 

  • Ability to work proactively, cross-functionally and effectively applying creative problem-solving skills

  • Excellent strategic planning, organizational and communication skills

  • Managerial experience working within or leading high-performance, cross-functional matrix teams

Behavioral Attributes:

  • Leadership (expertise, self-awareness, high performance behaviors and ability to execute the assigned role(s)) in a matrix and line environment

  • Acting as a coach and/or mentor to one another and other members of the team, especially junior physicians in the matrix and therapy area

  • Driving a disciplined approach to clinical research by ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence

  • Embedding a culture of individual empowerment across the broader study team

  • Leading by example and modelling the GSK Behaviors:

    • Flexible Thinking

    • Continuous Improvement

    • Customer Driven

    • Developing People

    • Enable & Drive Change

    • Building Relationships

Preferred Qualifications:

Board certification/eligibility, and clinical experience in oncology or hematology/oncology preferred

Experience in Cell and Gene Therapies highly preferred.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.

  • Managing individual performance.

  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.

  • Setting strategic direction and leading on-going organisational transformation.

  • Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.

  • Managing P&L and capital allocation.

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