Senior Director, Early Development Leader
- Stevenage, United Kingdom
Are you a strategic, collaborative and visionary leader looking to drive the early development of clearly differentiated medicines and enable accelerated development and seamless transition to late stage development? We need your leadership, vision and expertise in immunology, G, Pain and/or neuroinflammation to drive our exciting pipelines forward.
The Early Development Leader (EDL) is the single point of accountability to strategically lead the development of a medicine from the preclinical setting (Candidate Selection (CS)) through early clinical development (end of phase 1). This is a decision-making position with high visibility and direct interaction with senior management. You will lead a multidisciplinary team which will define, implement, and oversee the early development strategy for an asset. Collaboration and influence are critical to this position as you will be working with various stakeholders across R&D, obtaining and managing resources, and delivering evidence to support continued development and go/no-go decisions. The EDL is accountable for leading and driving teams to perform to their best. You will use your drug development experience to develop the medicine drawing from your scientific, clinical, and commercial knowledge or experience.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses (Pharmaceuticals, Vaccines & Consumer Health) research and deliver innovative medicines, vaccines and consumer healthcare products. In Pharmaceuticals, our new approach to R&D focuses on science related to the immune system, and the use of genetics and investments in advanced technologies (view video on www.gsk.com to learn more about our new strategy). We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
EDL's accountability and key responsibilities include but are not limited to:
- Strategic leadership and single point of accountability for the development of an asset or portfolio of assets within Research.
- Contributing to and establishing the development strategy with input and alignment from late stage development, commercial, and medical.
- Maximize life cycle management as part of the strategic development of the asset.
- Making clear evidence-based go/no-go/or accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points.
- Delivery of the package of evidence for a medicine of value.
- Strategically partner with Research Unit Heads, Clinical Pharmacology & Experimental Medicine and other disciplines to ensure alignment with organizational priorities and maximize the asset's portfolio options including developing multiple indications.
- Provide key support to the discovery Project Team in the lead up to Candidate Selection and to the Medicines Development Team to ensure alignments and smooth transfer of accountability.
- Works closely with the Project Leader and Medicine Development Leaders to ensure a smooth transition between the Project Leader to Medicine Development Leaders (Phase 2 to approval in first major market).
- Significant input in selecting members of the Early Development Team (EDT), in consultation with the line leaders, and then leads this multi-disciplinary matrix team. Supports differentiated development for team members and owns the performance of the EDT.
- Ensures excellence in execution of all governance processes and ensures that team accountabilities, including study oversight, pharmacovigilance, scientific engagement, and promotional practices are in line with the development strategy and in line with GSK expectations.
- Prioritization of activities and management to meet budget constraints.
- Models GSK values and leadership expectations.
- Additional Responsibilities May Include:
- Scientific Engagement
- Identifies and engages the external community appropriately in robust scientific dialogue that generates insight and advances scientific and medical understanding.
- Ensures timely and appropriate interaction and exchange of information between GSK and external communities (e.g., patients, physicians, payers, regulators), in strict adherence with GSK Policies, and GSK Global Scientific Engagement Principles and Standards.
- Regulatory and Competitive Awareness
- Proactively identifies unique regulatory requirements that are necessary for the development of early stage development e.g. introduction of first dosing in patient populations, clinical pharmacology and metabolism.
- Anticipates the changing healthcare & competitive environment and delivers innovative strategies and plans to generate evidence for relevant pharmacology/efficacy and prescribing/ usage within this environment.
- Understands the impact of new data on the value/positioning of products in guidelines/formularies.
- Business Development
- When necessary in early stage, partners with Business Development to facilitate diligence reviews, product positioning and/or alternative business strategies.
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree
- 10+ years drug development experience in the pharmaceutical industry
- Knowledge/understanding of preclinical medicine development, translational medicine, including experimental medicine design and their appropriate application to the project.
- Familiarity with all aspects of the strategic drug development and planning through to commit to phase 2.
- Project leadership of multidisciplinary teams in a matrix environment.
- PhD, MD (or equivalent)
- Able to develop, articulate, and mobilize the strategic development of an asset.
- Experience or expertise in immunology, GI, pain and/or neurodegenerative / neuroinflammatory diseases areas such as Parkinson's Disease, Multiple Sclerosis, Dementia or related areas.
- Demonstrated project leadership for an early clinical phase asset (pre-clinical and phase 1/phase 2).
- Ability to integrate and lead a team of multi-discipline experts including biology, chemistry, safety assessment, regulatory, clinical, clinical operations, clinical pharmacology, statistics, and CMC (chemistry, manufacturing, and controls).
- Exceptional capability to influence leadership.
- Proven ability to think and plan strategically, to lead and work with members of other functions within a matrix environment.
- Familiarity with regulatory interactions and pathways.
- Ability to align resources (people and financial), team objectives and strategies behind the vision; ensures resource gaps are identified and where possible, filled or managed
- Adept at:
- Embedding talent management throughout the team
- Provide constructive feedback to enable team members to perform to their optimum
- Create and lead an empowered, motivated team where diversity of thought is encouraged.
- Able to engage and leverage internal and external networks to drive performance and results.
- Understands the entirety of R&D across the development/commercial life cycle.
- Embedding talent management throughout the team
- Operating at pace and agile 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.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
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