The qualifications and experience required for the Medicines Development Lead role include:
• MD or equivalent
• Board Certification and clinical experience in Rheumatology, Gastroenterology, Immunology or Internal Medicine.
• Filing experience BLA/NDA (as relevant to the asset) and MAA submissions as a core responsibility and have led development programs.
• Must demonstrate deep drug development expertise and experience
o Considerable pharmaceutical industry experience is required
o Prior significant experience in leading successful development and registration of immunoinflammation drugs is highly preferred
o Deep experience in all phases of product development, especially in late phase development (from PoC onwards), 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
• Business acumen and 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
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provides a platform for delivering strong growth and responding quickly to the rapidly changing global healthcare environment. We are focused around 3 core businesses, Consumer Healthcare, Pharmaceuticals and Vaccines, with global commercial infrastructure and functional support, international supply networks and innovative R&D. We have a global commercial presence in more than 150 markets, a network of 84 manufacturing sites in 36 countries and large R&D centre in the UK, US, Belgium and China.
ImmunoInflammation Therapy Area Unit
The ImmunoInflammation Therapy Area Unit (iiTAU) is dedicated to discovering transformational therapies for immune-mediated inflammatory diseases (IMID) and osteoarthritis (OA). Our integrated strategy is focused on transformational treatments of a variety of IMIDs and OA, aiming at disease remission and prevention of tissue damage and disease. The Discovery Performance Units and Late Stage Clinical Group work closely together to deliver cutting edge science, early phase discovery, experimental medicine and late stage clinical studies all the way through to post-launch development, including full product life cycle. The iiTAU has deep collaborations with leading academic centres; these collaborations are closely aligned with strategic need and delivery of the portfolio. We also have complementary partnerships with leading biotechs and other pharma companies.
This integrated iiTAU organization includes:
- Experimental Medicine Unit
- Dermatology Unit
- Discovery Performance Units (DPUs)
o Cytokine, chemokine & complement (C3)
o Pattern Recognition Receptor
- Medicine Development Leaders (MDLs)
- Late Stage Clinical Development
The MDL Role
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.
MDL's accountability and key responsibilities include but are not limited to:
• Delivers differentiated 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.
• Prioritization and management of assets' portfolio options to meet budget constraints.
• Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices.
• Model values and Leadership Expectations inside and externally
• May lead multiple indications of an asset spanning multiple therapeutic areas simultaneously
You are a talented and experienced leader with a proven ability to think and plan uniquely and strategically, to work with members of other functions within a matrix environment and you should have well developed leadership skills.
Your experience includes having designed and run (to completion) clinical development programmes, including accountability for all aspects of the planning. You will lead the clinical development matrix team, be a leader of the Medicines Development Team and work closely with both the Global Medical Affairs Lead (GMAL) and Project Physician Lead (PPL). You will also be required to present to senior management (e.g., Chief Medical Officer) and relevant internal governance committees or external Advisory Committees as needed. You will also be a key member of the II Leadership team.
The MDL will play a key role in increasing visibility of GSK's profile amongst the physicians' community in order to bring medical solutions to patients with serious unmet needs.
- 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 competencies required for the role. Your cover letter along with your brief will be used to assess your application.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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