Clinical Development Lead- Early Immuno-Oncology Clinical Development
- Collegeville, PA
Site Name: UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Feb 9 2021
Are you keen to join the excitement and energy of the Clinical Teams in a leadership role within the GSK Immuno-Oncology Clinical Development at GSK? If so, thispositionmay be an ideal opportunity to explore.
GSK Oncology R&D is focused on building industry-leading portfolios in four cutting-edge areas of science:
•Immuno-Oncology : using the human immune system to treat cancer
• Cell/Gene Therapy: engineering human T-cells to target cancer
•Cancer Epigenetics: modulating the gene-regulatory system of the epigenome to exert anti-cancer effects
•Synthetic Lethality: targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer
Reporting to the VP Clinical Development-Immuno-Oncology, the Clinical Development Lead (CDL) - Early Immuno-Oncology will be an integral part of the Immuno-Oncology clinical platform as the single point of accountability for the Clinical Development Plan (CDP) of a medicine(s) in development. The CDL - Early Immuno-Oncology provides clinical and strategic leadership to early phase clinical programs.
Key elements of the role include:
- A key member of the Medicine Development Team representing Clinical Development
- Provide a single Clinical Development accountability at the program level into Medicine Development Team, Early Development Team, Medical Affairs, Integrated Evidence, Publications, and Global and Regional Commercial functions
- Accountable for overall benefit : risk of a clinical program
- Lead cross-functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program
- Act as the single point of accountability for oversight of multiple clinical development plans (CDPs), disease strategies, molecules and/or indications from end-to-end, as well as associated clinical trial programs and studies
- Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment to enable effective and efficient CDP execution
- Contribute strategic guidance and highlight clinical considerations to inform portfolio development strategies, individual study design and conduct, combination strategies, and disease area strategies
- Interpret complex clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries
- Prepare for governance discussions in close collaboration with cross-functional Medicine Development Leader (MDL) and other business lines
- Manage a team of physicians and/or scientists and allocate resources across the program accordingly
Additional responsibilities include:
- Oversee medical monitoring activities for one or more early stage asset(s)
- Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and content
- Contribute to the establishment of standards for clinical documents and data review processes across Oncology Clinical Development
- Participate in interpretation of data analyses of clinical trial results and support the development of clinical study reports
- Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, annual reports, etc.)
- Serve as program clinical expert for internal and external collaborators, investigators, consultants, and contract resources
- Lead and provide clinical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
- Lead recruitment, hiring and training for direct report team roles
- Provide direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins and 1:1 meetings
We are looking for professionals with these required skills to achieve our goals:
- Physician-scientist with strong understanding of translational disease biology or ability to design innovative trials based on emerging biomarkers and clinical outcome measures
- M.D. or M.D./Ph.D. (or ex-US equivalent)
- At least 8 years pharmaceutical or relevant scientific/medical/clinical experience required, with at least 5 years in Oncology.
- Established track record of scientific publications and presentations
- Experience leading matrix teams with a strong reputation of inspiring and motivating high performance
- Cross-functional medicine development knowledge and business acumen.
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology
- Highly effective communication skills; able to present complex data, design, strategy to groups at all levels of the organization
- Demonstrated ability to produce written scientific communications with clarity, accuracy and rigor and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange
- Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions
- Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Comprehensive understanding of product and safety profiles
- In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
- Board certification/eligibility or clinical experience in oncology is preferred
- Experience in Immuno-Oncology is preferred, but not required
- Ability to adjust behaviors and priorities based on changing environment and dynamics
- Ability to engage in, and contribute to, Oncology Clinical Development Culture and broad GSK environment with confidence, impact, integrity and professionalism
- Demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients
- Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a clinical perspective
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, rigor and risk
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Leadership (expertise, self-awareness, high performance behaviors and ability to execute the assigned role) in a matrix and line environment
- Embedding a culture of individual empowerment across the broader study team
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