ONCOLOGY: (4) Vice President/Medicine Development Leaders (ICOS, OX40, I-BET and BCMA)
- M.D., M.D./Ph.D., Ph.D. or Pharm.D. required
- Must demonstrate immuno-oncology drug development expertise and experience
oPharmaceutical industry (at least 5-10 years) is required
oPrior experience in leading successful development and registration of oncology drugs is highly preferred, BLA/NDA and MAA filing experience is a must
oDeep experience in all phases of product development, especially in late phase development, clinical trial management, post-approval studies, regulatory and manufacturing compliance.
- Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.
- Understands the entirety of R&D across the development/life cycle in order to impact across all line functions: discovery, late stage development, regulatory, manufacturing and commercial
- Track record of success working in highly complex, global, and/or multi-disciplinary structures with high accountability, minimal authority, and multiple lines of reporting
- Experience of working with regulators and regulatory requirements including an understanding of the legal and government frameworks within and across global geographies
- Strong people management, leadership and motivational skills
- In-depth experience creating the strategy for pre- and post-marketing studies, and driving the lifecycle process of oncology products
- Ability to work collaboratively and successfully across functions (R&D, commercial, regulatory, global medicine supply, legal, etc.) and regions
- Ability to build relationships and create authentic alignment while leading high performing teams in a collaborative and purposeful manner to achieve defined objectives
- Must be able to clearly demonstrate a thorough understanding of the healthcare environment including all key external stakeholders
- Experience of managing a sizable P&L. Experience of building budgets and then leading the strategic and budget planning process for their area
- Experience of leading geographically dispersed teams including influencing without authority
- Track-record of developing and delivering successful outcomes through a multi-functional team.
CORE COMPETENCE PROFILE
The ideal candidate will demonstrate the following competencies:
Strategic Portfolio Mindset - Has a deep understanding of GSK global strategies, identifies how these can be applied, leveraged and adapted across local-regional contexts whilst fostering innovation.
Project Leadership and Governance - Effectively manages different business functions and creates alignment between different projects and asset teams with different objectives.
Business and Resource Planning - Understands cost, financial, and performance drivers; identifies commercial opportunities; enables confident yet creative decision-making in ways that challenge the status quo.
Engaging Stakeholders in a Complex Environment - Utilizes organizational channels, experience and influencing skills to facilitate successful project progression and effective issue resolution
Technical Competencies in the following areas - Project Governance, Integrated Development Expertise & Insight, Evidence Generation, Scientific Engagement, Lifecycle Management, Business Acumen, Value & Patient Access, Business Development
GSK Oncology R & D:
Oncology is an area of high unmet medical need, providing fertile grounds for rapid growth. The lack of effective therapies for most of the advanced cancers, coupled with substantial progress in basic cancer biology and new technologies, provide unparalleled potential for innovation and transformational science. Oncology R&D is focused on building industry-leading portfolios in 3 cutting-edge areas of science: Immuno-Oncology, Cancer Epigenetics, and Cell Therapy. Our vision is to achieve a long term leadership position in Oncology by delivering Transformational Medicines that Maximize Patient Survival.
Overall, Oncology R&D has an exciting portfolio with several opportunities for first or best in class monotherapy agents in addition to significant opportunities for potentially transformative combination therapies. Our strategy is to foster innovation and leverage internal and external partnerships to enable combinations and accelerate development.
The Vice President and Leader of the Medicine Development Team reports to the SVP Oncology TA and is the key architect, accountable for defining and developing the strategy, including obtaining and managing associated resources (including budget accountability) and overall successful delivery for a medicine.
Delivers medicines of value that patients, stakeholders and market needs through an evidence package that supports regulatory approval, market access, and product life cycle.
Delivers the Medicine Development Strategy that is aligned with the therapeutic area disease strategy, as well as the asset Medicine Vision and Target Medicine Profile.
Prioritizes and manages asset's portfolio options including developing multiple indications.
Selects, evaluates and develops core members of the multi-disciplinary Medicine Development Team.
Primary Responsibilities include but is not limited to:
Ensures compliance with industry and corporate ethics, policies and standards and with regulatory and legal frameworks.
Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices.
Creates and communicates an innovative Medicine Vision and Target Medicine Profile that clearly define the value of our medicines/products in meeting the needs of patients, prescribers, consumers, regulators and payers.
Creates, communicates and executes Medicine Development Strategy and Clinical Development Plan (CDP) to deliver evidence package that will support both regulatory approval and payer reimbursement.
Develops and executes robust pre- and post-registration evidence generation plans to enhance the value of our products in a real-world and life-cycle management (LCM) setting.
Creates the final drug label resulting from a successful BLA/NDA or MAA filing.
Creates a strong bridge between R&D, commercial, and global medicine supply through robust strategic planning and implementation. Partners across all functions relevant for the development of the asset including Medical/Scientific Affairs, CMC, PCPS, development teams, external industry partners and academic collaborators.
Applies expertise and insights to enhance the Value Proposition of our products.
- Clinical Development: Responsible for oversight of development and execution of studies linked to worldwide clinical development plans for assigned programs in portfolio. Responsible for integrating clinical development objectives with global considerations into strategic business decisions. Ensures clinical, operational and medical governance excellence across all clinical development projects for assigned programs.
Evaluates the efficacy and safety of drugs in human clinical studies. (Phases I to IV) involving patient interaction and/or research, consulting, bench work and/or analysis. Provides medical expertise to ensure the proper development of new products and the optimal positioning and promotion of existing products.
Accountable for global oversight, coordination, and approval of scientific engagement activities pre-authorization.
Secures advice to inform the development of products of value, for the benefit of patients and consumers.
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.
Proactively identifies unmet needs that could be addressed through line extensions e.g. novel indications, combinations or formulations, or the provision of enhanced services.
Anticipates the changing healthcare, regulatory & competitive environment throughout the product lifespan; defines and delivers innovative strategies and plans to inform evidence-based prescribing/ usage within this environment e.g. new comparator or real world efficacy data.
Understands the impact of new data on the value/positioning of products in guidelines/formularies.
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.
Please use the cover letter to highlight how you meet the qualifications and competencies for the role. Your CV along with your cover letter will be used to assess your application.
You may apply for this position online by selecting the Apply now button.
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