• M.D., M.D./Ph.D., Ph.D or Pharm. D. required
• Must demonstrate oncology drug development expertise and experience
o Pharmaceutical industry (at least 5-10 years) is required
o Prior experience in leading successful development and registration of oncology drugs is highly preferred, BLA/NDA and MAA filing experience is a must.
o Deep 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/commercial 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
Cell therapy is one of the three focused areas of GSK Oncology R&D. Our lead T-cell therapy NY-ESO TCR targets the NY-ESO-1 peptide, one of the best-characterized and most immunogenic cancer testis antigens that is frequently expressed on cancer cells across multiple cancer types. Multiple Phase 1/2 clinical trials are investigating NY-ESO TCR therapeutic candidate in patients with solid tumors and hematological malignancies including synovial sarcoma, multiple myeloma, melanoma, NSCLC, and ovarian cancer. Tumor responses and evidence of durable clinical benefits in patients with both synovial sarcoma and multiple myeloma were observed. Based on preliminary encouraging clinical efficacy, NY-ESO-1 TCR has been granted Breakthrough Therapy and PRIME designation by the US FDA and EMA respectively.
Vice President and Leader of the Medicine Development Team who 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.
- 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.
Requisition ID: WD140957