VP Early Assets, Open to flexible working
- Senior Global Medical leadership role for Early Assets as part of Specialty & Primary Care Global Medical Affairs Organization.
- Responsible for leading Global Medical Affairs team accountable for developing, driving and executing Global Medical Affairs strategy for the medicines and/or Therapy Area mentioned above in partnership with Global Medical Affairs partners, Global Commercial/Product & Portfolio Strategy (early Commercial & BD), Clinical Development functions and Research.
- Provides Strategic Medical and Scientific Leadership to management and project teams.
- Provides Clinical support, Disease Area Expertise, Patient and Prescriber Insights, Global viewpoint of safety and efficacy at the portfolio level, including proposed new areas of interest for assets in development and portfolio strategy and prioritisation.
- Participates and shapes the Medical strategy as a member of the Early Development Team (EDT).
- Provides Medical thought leadership and input into different work packages of the IAP (Integrated Asset Plan) in alignment with the Global Medical accountabilities e.g. disease landscape, treatment paradigms, external engagement plans etc.
- Develops and maintains Medical Affairs Excellence through talent identification, recruitment, development and retention, especially of physicians to support the pipeline.
- Participates in the design of Clinical development plans and study protocols, accessing world-class expertise through external and internal collaboration, harnessing digital, technological and statistical tools.
- Ensures quality of Medical deliverables within Development including all documents and submissions including clinical data, through methods such as peer review, knowledge sharing/management, and standards and compliance.
- Active collaboration on Research & Development projects (from CS-Candidate Selection onwards) and PPSG - Product Portfolio Strategy Group; early commercialization and business development/due diligence activities).
- Leads Medical affairs project oversight within early assets team.
- Communicates Medicine and Evidence Generation strategies to the medical leaders in the LOCs and Regions, implementation of global scientific engagement programmes and gathering insights from franchise LOCs and external stakeholders (patients, physicians, payers and regulators).
- Represents Medical Affairs function in appropriate governance committees, including but not limited to, Safety Review Team, RRB and DRB (as needed).
- Attract and retain an engaged and diverse group of the highest performing professionals
- Create an environment where colleagues understand and exhibit customer focused medical professionalism in all their functions
- Ensure a collaborative working environment within Medical and Scientific functions as well as across functions on brands to drive strategic advancement.
- Lead a team of global medical and scientific professionals within early assets to contribute to business planning, strategic partnering with EDL, PPSG, to plan and deliver scientific engagement and medical performance for pipeline assets.
- Drives the Medical Affairs input into Integrated Asset Plan (IAP).
- Drive the scientific objectives and medical plan for the assets.
- Accountable with the team to work within GSK's compliance framework.
- Ensure global strategy is effectively communicated and executed at regional and country levels and that key LOC needs are appropriately accommodated in global deliverables and vice versa. (as applicable)
- Chairs Medical advisory boards with compliance, focus, dynamism, science and aiming towards outcomes and efficiency.
- Develops scientific strategic partnership with global guidelines bodies and interacts when needed with Global Regulatory agencies like FDA, EMA, JFDA, CFDA as well as relevant access bodies.
- Works in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy.
- Engages with high levels of proactivity towards scientific leadership with priority LOCs and Commercial Partners.
- Gather medical insights from community of internal and external experts as well as from LOCs and key external stakeholders to inform and shape medicine strategy and to be active and insightful medical leader for the development of the integrated evidence strategy and plan (from CS onwards)
- Accountable for the input and scientific leadership from Medical Affairs perspective in development programs/LCMs as it may apply.
- Collaborates in the selection of scientific strategic areas of interest and provide oversight of Investigator Sponsored Studies through the call for proposals process (if needed). Collaborate with external experts to develop collaborative trials (if needed.
- Develops meaningful interactions/collaboration external stakeholders in the disease areas related to the assets from CS.
- Member of the medical TA leadership team responsible for leading and developing people including recruitment and talent reviews and financial planning in relation to annual budget cycles.
- Driving excellence in Scientific Engagement, i.e. interactions with HCPs, Patients, Payors and Regulators; building a strong external network of key stakeholders.
- Ensuring appropriate level of resources, capabilities and processes to ensure medical governance is supported across all the TA medical teams in cooperation with the regions.
- Acting as spokesperson and ambassador for GSK's products both within and outside GSK as appropriate.
- Recruiting/developing high caliber individuals and building a high-performance medical team across all therapeutic areas.
Basic Skills and Experience
- Qualifications - MD PhD with Specialism within Immunology - Infectious Diseases - Rheumatology
- Leadership capability - Demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.
- Strategic Thinking - Maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems.
- Business Acumen - Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D.
- Project Management - Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.
- Medical Affairs - Prior asset launch experience, with design and execution of in country and above country strategies.
- Clinical Development - Demonstrates an understanding of the required steps to progress a new chemical lead through the stages necessary to allow it to be tested in human clinical trials. Has demonstrated experience in the design, development, execution, statistical analysis, clinical interpretation and reporting of high-quality clinical studies.
- Good Clinical Practice Knowledge - Demonstrates the ability to ensure an investigation is conducted according to applicable Good Clinical Practice regulations and internal control documents, to protect the rights, safety and wellbeing of subjects and the accuracy and validity of the trial data.
- Clinical Judgement Experience - Proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOPs, policies, guidance and codes.
- Scientific and Medical Knowledge - Demonstrates a current, in-depth understanding of the relevant drug and associated therapeutic and disease area.
- Clinical Data Stewardship - Demonstrates an understanding of the critical importance of rigorous data generation and disciplined stewardship of the data.
- Medical Monitoring/Pharmacovigilance - Demonstrates an understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. Knows when to involve GCSP for escalation e.g. to the Chief Medical Officer, Global Safety Board.
- Reimbursement/Market Access Knowledge - Demonstrates a thorough understanding of the attributes of a medicine that are likely to be valued by payers, and the evidence required to support the payer value proposition. Understands the importance of designing and executing the trial to achieve future marketing authorisation.
- Scientific Writing - Demonstrates the ability to produce scientific communications with clarity, accuracy and rigour and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange.
Preferred Skills and Experience
- Experience of leading a full life cycle development program from pre-clinical through to launch
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.