Are you energized by an opportunity to accelerate and deliver clinical safety and compliance across multiple clinical programs? If so, this Clinical Development Manager/Principal role could be an exciting opportunity to explore.
This job as a Study Delivery Lead (SDL) within VEO Study Delivery and Quality Operations combines end-to-end design, execution, and reporting of Vaccine and Pharma regional studies and activities including:
- Non-interventional studies using primary data collection, including prospective studies enrolling patients and or/HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g. with EMRs/chart abstraction), patient reported outcomes development and validation
- Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilization studies, prevalence/incidence studies of exposure, risk factors and outcomes
- Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients
- Economic modelling studies and supplemental analyses of clinical trials/meta-analyses
Key attributes include scientific credibility, demonstrated ability to input to and influence studies/projects through scientific and operational expertise, and demonstrated excellence in stakeholder management. This job requires the ability to lead and drive change, strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity..
Essential behavior's valued include: The ability to lead and inspire others, continuous improvement and learning, and effectiveness at building networks of partners and stakeholder's. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Why you? Basic Qualifications:
- Responsibility and/or accountability for the set-up, co-ordination, execution and delivery of the VEO portfolio in partnership with the Science Lead
- Planning and leading the delivery of VEO studies to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
- Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
- Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc.)
- With the majority of VEO studies fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
- Ensure compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate.
- Work with matrix partners, Study Delivery Regional and Therapy Area Leads and/or manager to develop and manage study level budget within project budget allocation
- Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in related field
- Three or more years experience in the pharmaceutical industry and the clinical development process
- One or more years of study management and knowledge of essential
- regulatory guidelines worldwide
If you have the following characteristics, it would be a plus:
- Master's Degree in a related field
- Demonstrated experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change
- Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
- Excellent leadership skills
- Excellent influencing and negotiation skills.
- Ability to translate scientific skills in clinical research into business-driven strategies
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge 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.
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