Group Senior Clinical Development Director, Hepatitis B
- Employer
- GSK
- Location
- San Francisco, California; Philadelphia, Pennsylvania; Waltham, Massachusetts; Collegeville, Pennsylvania
- Salary
- Competitive
- Closing date
- Aug 18, 2022
View more
- Discipline
- Health Sciences, Medicine
- Job Type
- President/CEO/Director/VP
- Organization Type
- All Industry, Pharma
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Are you energized by the opportunity to lead global drug development programs, creating novel clinical development/regulatory pathways and driving accelerated business performance to bring differentiated treatments to patients with hepatitis B? If so, consider exploring this opportunity.
A Group Senior Clinical Development Director is being sought to bring clinical and scientific leadership for late-stage assets to enhance the GSK hepatitis B portfolio.
As Group Senior Clinical Development Director, you will be responsible for at least three clinical development teams to advance our antisense oligonucleotide medicine bepirovirsen in phase 2 and phase 3 both as monotherapy as well as in combination with antiviral and/or immunomodulatory investigational agents.
And at the same time, you will have the opportunity to work with GSK scientists in early clinical development, in business development as well as with partners in the greater medical scientific community beyond GSK.
You will have direct line management responsibilities, leading senior directors and clinical scientists in a matrix role across clinical science. You will also engage with other important GSK functions including clinical development, medical affairs and commercial.
You will report into the Vice President, Disease Area Lead GI/Hepatology, Clinical Sciences.
Key responsibilities:
Why You?
Basic Qualifications:
Preferred Qualifications:
Why GSK?
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.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using thescience of the immune system, human genetics and advanced technologiesto get ahead of infectious diseases, HIV, cancer and other immune-mediated and respiratory diseases.We do all this with a commitment to operate responsibly for all our stakeholders by prioritisingInnovation, Performance and Trust.
Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and medicines, including innovative new products, will reach more people who need them than ever before.
We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That's why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.
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.S o, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
#LI-GSK
# LI-Hybrid
#ClinicalSciences
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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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.
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.
A Group Senior Clinical Development Director is being sought to bring clinical and scientific leadership for late-stage assets to enhance the GSK hepatitis B portfolio.
As Group Senior Clinical Development Director, you will be responsible for at least three clinical development teams to advance our antisense oligonucleotide medicine bepirovirsen in phase 2 and phase 3 both as monotherapy as well as in combination with antiviral and/or immunomodulatory investigational agents.
And at the same time, you will have the opportunity to work with GSK scientists in early clinical development, in business development as well as with partners in the greater medical scientific community beyond GSK.
You will have direct line management responsibilities, leading senior directors and clinical scientists in a matrix role across clinical science. You will also engage with other important GSK functions including clinical development, medical affairs and commercial.
You will report into the Vice President, Disease Area Lead GI/Hepatology, Clinical Sciences.
Key responsibilities:
- Lead matrix team of senior clinicians and clinical scientists with responsibilities for various clinical development programs addressing the global medical need of chronic hepatitis B.
- Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching.
- Identify and highlight acceleration, innovation and transformational opportunities where projects can offer highly significant benefit to patients with hepatitis B infection.
- Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourage others to think differently and generate creative business solutions.
- Oversee the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for those assets in development under your leadership.
- Provide strategic leadership in designing the CDPs and IEPs, taking into account the scientific rationale, regulatory requirements, product development plan and commercial goals for these products.
- Develop and maintain relationships with corporate counterparts in Commercial, Early Development, Research, Regulatory Affairs, Clinical Operations, Biostatistics and other functions.
- Oversee clinical aspects of Business Development activities, including due diligence projects.
- Serve as a clinical point of contact for senior management and senior level matrix teams.
- Interface with and influence a range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs that align to business strategy and address patient needs
- Identify and highlight acceleration and value-finding opportunities where projects can offer highly significant benefit to patients.
- Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.
- Make substantial contributions to regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions.
Why You?
Basic Qualifications:
- MD and/or PhD and/or PharmD degree.
- Significant industry experience in clinical drug development.
- Experience with leading and driving strategic clinical development planning for an asset and/or indication.
- Proven record of delivery of clinical trials and projects.
- Knowledge of clinical research methodology and principles of biostatistics to facilitate accelerated, innovative and efficient designs of clinical development plans with clear data-driven decision rules.
- Line management, coaching, mentoring and development experience. Experience leading line and matrix teams with a track record of inspiring and motivating high performance.
- Strong leadership skills, with proven ability to inspire high performance from cross-functional teams.
- Track record of building and maintaining strong relationships with internal and external stakeholders.
Preferred Qualifications:
- Past and/or ongoing post-graduate clinical experience in taking care of patients with chronic hepatitis B infection.
- Demonstrated experience in clinical development of investigational agents to treat chronic hepatitis B.
- Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements.
- Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s).
Why GSK?
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.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using thescience of the immune system, human genetics and advanced technologiesto get ahead of infectious diseases, HIV, cancer and other immune-mediated and respiratory diseases.We do all this with a commitment to operate responsibly for all our stakeholders by prioritisingInnovation, Performance and Trust.
Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and medicines, including innovative new products, will reach more people who need them than ever before.
We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That's why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.
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.S o, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
#LI-GSK
# LI-Hybrid
#ClinicalSciences
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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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.
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.
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