GSK
Executive Director, Early Development Leader
GSK, Collegeville, Pennsylvania, United States, 19426
The
Executive Director, Early Development Leader
(EDL) is a high-responsibility, strategic role, critical for developing the vision and trajectory for a medicine that maximizes its opportunity for GSK and benefit for patients.
If you want to know about the requirements for this role, read on for all the relevant information.The EDL is the single point of accountability to lead the development of a medicine from Candidate Selection (CS) through Proof of Concept (PoC), defining the criteria necessary to identify and progress game-changing medicines through creative and innovative experimental design.By working with various stakeholders across R&D, the EDL obtains and manages associated resources and delivers evidence in line with the strategic vision and organizational strategy to support progression beyond PoC for a clearly differentiated medicine.Key Responsibilities:The EDL's accountability and key responsibilities include but are not limited to:
Leadership of the Early Development StrategyContributes to and establishes the development strategy to support the Medicine Profile (MP)
Secures input and alignment from late-stage Development, Commercial, and Medical
Ensures development strategy is kept current, as internal priorities shift and the external landscape changes
Matrix Leadership of the Early Development Team (EDT)Leads the multi-disciplinary Early Development matrix team and owns the performance of the EDT
Makes clear and timely evidence-based go/no-go/accelerate decisions in line with the strategy
Ensures excellence in execution of all governance processes
Prioritizes activities and manages the early development plan to meet budget constraints
Ensures team accountabilities, including study oversight, pharmacovigilance, scientific engagement, and promotional practices are in line with the development strategy and GSK expectations
Delivers the package of evidence that supports the MP for a medicine of value
Models GSK values and leadership expectations
Business Partnering beyond the EDTProvides significant input in selecting members of the EDT, in consultation with the Functional Line leaders, supporting differentiated development for team members
Strategically partners with Functional Line Heads to ensure alignment with organizational priorities and to maximize the asset's portfolio options including developing multiple indications
Provides key support to the Project Team (PT) in the lead up to CS and to the Medicines Development Team (MDT) ahead of PoC to ensure alignment end to end on the drug development strategy
Works closely with the Project Leader (PL) and Medicine Development Leader (MDL) to ensure smooth transitions from the PL at Candidate Selection and to the MDL upon achieving PoC
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:Advanced degree (such as PhD, MD, PhRMD, MBA)
10 or more years pharmaceutical drug development experience
Pre-clinical and clinical experience in drug development with an emphasis on earlier stage clinical development and translational medicine
Matrix leadership experience
Experience building strategic plans and working with others within a matrix environment
Preferred Qualifications:
If you have the following characteristics, it would be a plus:Exhibits clinical development/end-to-end knowledge
Demonstrates thorough translational understanding (pre-clinical/clinical)
Experience or expertise in Immuno-Inflammation, Respiratory, Hepatology, Renal, Connective Tissue or Neurodegenerative diseases areas
Experience as a matrix leader able to work across technical disciplines and integrate requirements from matrix partners into a coherent evidence-generation and forward plan
Experience or clear familiarity / understanding of the attributes of early clinical development and importance of clinical pharmacology, modelling & simulation and statistics
Experience gathering early commercial insights and awareness of the impact of external factors, e.g., public policy, competitor landscape
Understands the relevance of early-stage questions, including tools and methodologies for addressing the questions: "learning about the asset" and appreciates limitations and strengths of the pre-clinical setting
Expertise/knowledge in translational medicine/experimental medicine design and management
Strong understanding of options for regulatory pathways, Life Cycle Management and sequencing of indications
Knowledge of manufacturing compliance and regulatory requirements
#LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.Important notice to Employment businesses/ AgenciesGSK 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.PDN-9d419749-7f87-40fc-812e-087740e4f13c
Executive Director, Early Development Leader
(EDL) is a high-responsibility, strategic role, critical for developing the vision and trajectory for a medicine that maximizes its opportunity for GSK and benefit for patients.
If you want to know about the requirements for this role, read on for all the relevant information.The EDL is the single point of accountability to lead the development of a medicine from Candidate Selection (CS) through Proof of Concept (PoC), defining the criteria necessary to identify and progress game-changing medicines through creative and innovative experimental design.By working with various stakeholders across R&D, the EDL obtains and manages associated resources and delivers evidence in line with the strategic vision and organizational strategy to support progression beyond PoC for a clearly differentiated medicine.Key Responsibilities:The EDL's accountability and key responsibilities include but are not limited to:
Leadership of the Early Development StrategyContributes to and establishes the development strategy to support the Medicine Profile (MP)
Secures input and alignment from late-stage Development, Commercial, and Medical
Ensures development strategy is kept current, as internal priorities shift and the external landscape changes
Matrix Leadership of the Early Development Team (EDT)Leads the multi-disciplinary Early Development matrix team and owns the performance of the EDT
Makes clear and timely evidence-based go/no-go/accelerate decisions in line with the strategy
Ensures excellence in execution of all governance processes
Prioritizes activities and manages the early development plan to meet budget constraints
Ensures team accountabilities, including study oversight, pharmacovigilance, scientific engagement, and promotional practices are in line with the development strategy and GSK expectations
Delivers the package of evidence that supports the MP for a medicine of value
Models GSK values and leadership expectations
Business Partnering beyond the EDTProvides significant input in selecting members of the EDT, in consultation with the Functional Line leaders, supporting differentiated development for team members
Strategically partners with Functional Line Heads to ensure alignment with organizational priorities and to maximize the asset's portfolio options including developing multiple indications
Provides key support to the Project Team (PT) in the lead up to CS and to the Medicines Development Team (MDT) ahead of PoC to ensure alignment end to end on the drug development strategy
Works closely with the Project Leader (PL) and Medicine Development Leader (MDL) to ensure smooth transitions from the PL at Candidate Selection and to the MDL upon achieving PoC
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:Advanced degree (such as PhD, MD, PhRMD, MBA)
10 or more years pharmaceutical drug development experience
Pre-clinical and clinical experience in drug development with an emphasis on earlier stage clinical development and translational medicine
Matrix leadership experience
Experience building strategic plans and working with others within a matrix environment
Preferred Qualifications:
If you have the following characteristics, it would be a plus:Exhibits clinical development/end-to-end knowledge
Demonstrates thorough translational understanding (pre-clinical/clinical)
Experience or expertise in Immuno-Inflammation, Respiratory, Hepatology, Renal, Connective Tissue or Neurodegenerative diseases areas
Experience as a matrix leader able to work across technical disciplines and integrate requirements from matrix partners into a coherent evidence-generation and forward plan
Experience or clear familiarity / understanding of the attributes of early clinical development and importance of clinical pharmacology, modelling & simulation and statistics
Experience gathering early commercial insights and awareness of the impact of external factors, e.g., public policy, competitor landscape
Understands the relevance of early-stage questions, including tools and methodologies for addressing the questions: "learning about the asset" and appreciates limitations and strengths of the pre-clinical setting
Expertise/knowledge in translational medicine/experimental medicine design and management
Strong understanding of options for regulatory pathways, Life Cycle Management and sequencing of indications
Knowledge of manufacturing compliance and regulatory requirements
#LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.Important notice to Employment businesses/ AgenciesGSK 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.PDN-9d419749-7f87-40fc-812e-087740e4f13c