Early Development Leader
Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Sep 6 2021 The Early Development Leader (EDL) is the single point of accountability to strategically lead the development of a medicine between Candidate Selection (CS) and through the end of phase 1 (Commit to Phase 2; C2P2), substantially contributing to defining the early development strategy for an asset. By working with various stakeholders across R&D, they will obtain and manage associated resources, and deliver evidence in line with the strategic vision and organisational strategy to support progression beyond phase 1 for a clearly differentiated medicine. You will be a talented and experienced senior leader with a proven ability to think and plan strategically, to work with members of other functions within a matrix environment and should have well developed leadership and stakeholder management skills. They have accountability for the project from candidate selection through commit to phase 2. You will have in-depth knowledge/understanding of preclinical medicine development needs , translational medicine, including experimental medicine design and their appropriate application to the project. End to end familiarity and accountability for all aspects of the strategic planning through to commit to phase 2 which enables progression beyond phase 2 is key to the success of this role. The EDL will lead a development matrix team within a preclinical setting and into the clinical setting. As leader of the EDT, the EDL will work closely with representatives from biology, chemistry, safety assessment, regulatory, clinical, clinical operations, clinical pharmacology, statistics, and CMC. The EDL is accountable for developing individuals and teams to perform to their best. In addition, they will develop the medicine taking into account scientific, clinical, and commercial considerations. The 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 R&D, from candidate selection through C2P2 - Contributing to and establishing the development strategy aligned with Medicine Profile (MP) with input and alignment from late stage development, franchise commercial, and medical - Makes clear evidence-based go / no go / 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 that delivers against the MP for a medicine of value - Strategically partners with Research Unit (RU) heads and Clinical Pharmacology & Experimental Medicine (CPEM) to ensure alignment with organisational priorities and maximise the asset's portfolio options including developing multiple indications - Provide key support to the Project Team (PT) in the lead up to CS and to the Medicines Development Team (MDT) to ensure alignments and smooth transfer of accountability - Works closely with the Project Leader (PL) and Medicine Development Leader (MDL) to ensure a smooth transition between the PL (accountable up to Candidate Selection) to MDL (accountable from 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 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 - Prioritisation of activities and management to meet budget constraints - Models GSK values and leadership expectations Key Responsibilities This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… - Works in partnership with early medical, late medical/MDL, and commercial to ensure alignment and continuity with medicine vision and development. Establishes a compelling early vision for the medicine (Medicine Vision); in line with the R&D strategy - Integrates multiple considerations into the planning process; substantial contribution to the design and delivery of evidence in support of C2P2 progression and the vision for the medicine towards file, launch and reimbursement of clearly differentiated medicine(s) - Defines clear inflection points and understands how to accelerate programs - Devises strategies to augment and complement the GSK future portfolio - Embeds good business practice, including cost efficiency, adoption of new technology, risk identification & management, compliance with policy, external partnering and risk sharing - Enhances patient focus / ensures the plan is informed by patient insight - Assures quality of data and science for the program they lead; enhance quality culture - Ensures quality & compliance oversight in line with R&D expectations and project needs (ABAC, Scientific Engagement, QBA, eTMF, HBSM, policy 408) - Aligns resources (people and financial), team objectives and strategies behind the vision; ensures resource gaps are identified and where possible, filled or managed - Embed talent management throughout the team; provide constructive feedback to enable team members to perform to their optimum; create and lead an empowered, motivated team; encourage diverse thinking - Own the performance of the EDT and partner with the RU Head and line managers to drive performance; support differentiated development for team members - Leads and facilitates successful project progression to plan and issues resolution; adapt / adjust the plan as needed - Considers product development / CMC options to develop an appropriate and coherent plan and execute delivery to plan. - Determines whether there is value in the molecule; simultaneously ask when we will know this molecule is not going to work and how do we show and deliver promise and generate the required supporting evidence (identification of inflection points) 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 - Ensures balanced and robust scientific communications in all formats 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 (e.g., public private partnerships, co-development) and internal review and decision-making processes in line with GSK governance procedures as well as use of appropriate alliance management mechanisms to ensure successful business transactions and relationships Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Advanced degree beyond bachelors e.g. PhD with significant post doctoral experience or MD/ PhD Significant research experience in the field of Immunology, Oncology or similar field Extensive industry experience managing and leading therapeutic research teams. Demonstrated experience in the following: - Experienced matrix leader able to work across technical disciplines - Exhibits clinical development/E2E knowledge - Understands relevance of early stage questions (including tools and methodologies for addressing the questions): 'learning about the asset” - Appreciates limitations and strengths of the preclinical setting - Has demonstrated or exhibits translational understanding (pre-clinical/clinical) - Experience or clear familiarity understanding of the attributes of early clinical development and importance of clinical pharmacology, modelling & simulation and statistics - Experience engaging appropriate academic and external experts (KOLs, EEs) to inform drug discovery and development - Proven ability to think and plan strategically, to work with members of other functions within a matrix environment and well-developed leadership and stakeholder management skills - In-depth knowledge/understanding of preclinical medicine development needs, translational medicine, including experimental medicine design and its appropriate application, as well as knowledge and experience of clinical development which includes end to end familiarity and accountability for all aspects of the strategic planning through to PoC which enables progression beyond PoC - Track record of developing individuals and teams to perform to their best strengths in the translation of preclinical science into the clinic in the context of a medicine vision - Expertise/knowledge in pre-clinical science as well as the utility/limitations of pre-clinical tools. - Established expertise/knowledge in early clinical development and translational medicine/experimental medicine - Knowledge of all phases of medicine development, including pre-clinical and clinical trial management and translational medicine studies/experimental medicine design and management - Knowledge/familiarity of end-to-end (E2E) development and processes. - Highly developed ethics and integrity, with demonstrated strategic decision-making skills Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience gathering early commercial insights - Experience developing an integrated evidence plan (IEP) and value plan (high level) as foundation for phase 2 and phase 3 development plans - Experience or strong familiarity with Life Cycle Management (LCM) and sequencing of indications consistent with asset overall strategy and lead indication - Awareness of external environment e.g. public policy, competitor landscape - Exhibits strength in understanding of options for regulatory pathways - May have led development programs (pre-clinical or clinical) with experience fulfilling requirements of regulatory filings to enter into clinical testing (e.g. IND) - Demonstrate deep drug development expertise and experience - Considerable pharmaceutical industry experience - Prior significant pre-clinical and clinical expertise in drug development with an emphasis on earlier stage clinical development and translational medicine - Knowledge of regulatory requirements and manufacturing compliance - Understands the entirety of R&D across the development/commercial life cycle in order to impact across all lines - Experience partnering with research heads, manages internal and external stakeholders concurrently, including Franchises, Regulators and Payers and integrates their requirements into a coherent evidence-generation and forward plan - Experience engaging with key customers & partners to drive the planning process and execute delivery to plan 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. 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