Site Name: Philadelphia Walnut Street, StevenagePosted Date: Feb 20 2025 The Interventional Study Scientist MedicalDirector will lead the scientific design of interventional clinicalstudies, medical governance, and interpretation of results withinthe Medical Affairs organization (non-regulatory label-directedprograms) for assigned asset(s)/indication(s). This role willpartner closely with the GML and GMT and is the single pointaccountability for translating the evidence strategy set by the GMTinto appropriate interventional studies. The study designed isexpected to fulfill a strategic objective of the clinicaldevelopment and integrated evidence plan. This role is pivotal inshaping data generation strategies and ensuring clinical trials areconducted with the highest standards of quality, ethics, andefficiency. The successful candidate will have deep expertise inindustry-sponsored clinical research, global medical affairs,commercial acumen, and cross-functional team leadership. They willoversee multiple projects independently and may be responsible forstudy development and implementation across an entire therapeuticarea. Key Responsibilities: Strategic Leadership: - Translating thestrategic vision for the therapeutic area and asset set forth bythe GMT into Medical Affairs interventional studies and aligningthem with GSK’s overarching goals. - Lead the design ofinterventional medical affairs clinical trials from Phase I throughPhase IV including integrated input from internal/external experts,thought leaders and patients. - Ensure alignment of interventionalstudy strategies with regulatory requirements and industry bestpractices. - Ensure that study objectives are consistent withdecision criteria in the clinical development plan and integratedevidence plan. - Ensure appropriate incorporation of design ofstudy into protocol. - Present the scientific rationale and studydesign at Investigator Meetings and responding to scientificquestions arising from sites during study conduct. Scientificoversight for the study: - Oversee benefit-risk of the study. -Ensure study analysis plan is aligned to objectives of the protocoland accountable for the clinical interpretation of study data andresults. - Review clinical data and study conduct to assure patientsafety and scientific integrity. This would include ongoing reviewof protocol deviations and implementation of remedial plans. -Oversee medical governance for the study including medicalmonitoring. Outputs for the study: - Interpretation of study datato create the scientific content of Clinical Study Report (CSR). -Preparation of study results for abstracts, posters andpresentations for scientific meetings, congresses, external journalpublications. - Preparation of clinical content of regulatorydocuments and interaction with global regulatory authorities forthe study (if needed). - Provides input into and reviews otherrelevant study document including the informed consent (ICF),protocol deviation management plan (PDMP), study reference manual(SRM). - Provides scientific content for other study specificdocumentation (e.g. slides for site/monitor/investigator training).- Collaborate with cross-functional teams to ensure seamlessexecution and delivery of clinical programs, in particular theclinical development operations and biostatistics teams, as well asthird party vendors. - Monitor and manage study progress, ensuringcompliance with protocols, regulatory requirements, and GSKstandards. Team Leadership: - Foster a collaborative and innovativeculture within the interventional studies team. - Provide guidanceand support for professional development and career growth of teammembers. - Partner with the Study Delivery Lead and Project Manager(in Clinical Operations) to ensure optimal delivery of the study. -Maintain close collaboration with various functions including drugsafety, regulatory affairs, biostats, TAs (GMLs and GMT) in medicalaffairs and clinical trial operations at the study level.Regulatory and Compliance: - Ensure that all interventional studiesare conducted in accordance with GCP, and other relevant regulatoryguidelines. - Maintain oversight of all regulatory submissions andinteractions related to interventional studies. - Ensure robustquality control and assurance processes are in place for allclinical trials. Stakeholder Engagement: - Serve as the primarypoint of contact for internal and external stakeholders regardingthe study. - Collaborate with key opinion leaders, investigators,and external partners to enhance study design and execution. -Communicate study progress, challenges, and outcomes to seniorleadership, the GML/GMT, and other relevant stakeholders.Innovation and Continuous Improvement: - Identify and implementinnovative approaches to improve the efficiency and effectivenessof interventional studies. - Stay abreast of industry trends,emerging technologies, and new methodologies in clinical research.- Promote a culture of continuous improvement within theinterventional studies team. Basic Qualifications: - Advanceddegree in a relevant scientific discipline (MD, PhD, PharmD, orequivalent). - 10 + years of experience in clinical research, with5 + years in a leadership role overseeing interventional studies. -Led at least three large-scale interventional clinical trials fromdesign to execution with demonstrated impact. - 5+ years ofexperience as a medical monitor, overseeing at least threeinterventional clinical trials in compliance with ICH-GCP, FDA,EMA, and other global regulatory requirements. - Experienceanalyzing and synthesizing data from multiple sources to drivedecision-making, demonstrated by at least three instances ofdata-driven recommendations impacting trial design or execution. -5+ years of experience leading cross-functional line or matrixteams at the study level, including managing direct reports orleading virtual teams. - Evidence of strong leadership skills withat least three examples of cross-functional collaboration onsetting direction, obtaining alignment, and engaging for resultsresulting in strategic outcomes. - Leading the resolution of atleast two significant trial challenges, such as protocolamendments, patient recruitment obstacles, or regulatory complianceissues, resulting in improved study timelines, data quality, orregulatory approvals as a measure of strategic think andproblem-solving. - Experience managing multiple priorities in afast-paced environment, overseeing simultaneous management of atleast three studies or strategic initiatives. PreferredQualifications: - Physicians and specialization in relevanttherapeutic area preferred. - Experience collaborating withregulatory authorities. - Familiarity with innovative approaches inclinical trial execution. - Exposure to working with key opinionleaders, investigators, and external partners. - Experience indeveloping scientific content for publications and regulatorysubmissions. - Understanding of digital tools and AI-drivenmethodologies for evidence generation. - Prior experience withcross-functional teams in a pharmaceutical or biotech setting.#LI-GSK The annual base salary for new hires in this positionranges from $170,250 to $283,750 taking into account a number offactors including work location within the US market, thecandidate’s skills, experience, education level and the market ratefor the role. In addition, this position offers an annual bonus andeligibility to participate in our share based long term incentiveprogram which is dependent on the level of the role. Availablebenefits include health care and other insurance benefits (foremployee and family), retirement benefits, paid holidays, vacation,and paid caregiver/parental and medical leave. Please visit GSK USBenefits Summary to learn more about the comprehensive benefitsprogram GSK offers US employees. Why GSK? Uniting science,technology and talent to get ahead of disease together. GSK is aglobal biopharma company with a special purpose – to unite science,technology and talent to get ahead of disease together – so we canpositively impact the health of billions of people and deliverstronger, more sustainable shareholder returns – as an organisationwhere people can thrive. We prevent and treat disease withvaccines, specialty and general medicines. We focus on the scienceof the immune system and the use of new platform and datatechnologies, investing in four core therapeutic areas (infectiousdiseases, HIV, respiratory/immunology and oncology). Our successabsolutely depends on our people. While getting ahead of diseasetogether is about our ambition for patients and shareholders, it’salso about making GSK a place where people can thrive. We want GSKto be a place where people feel inspired, encouraged and challengedto be the best they can be. A place where they can be themselves –feeling welcome, valued, and included. Where they can keep growingand look after their wellbeing. So, if you share our ambition, joinus at this exciting moment in our journey to get Ahead Together. Ifyou require an accommodation or other assistance to apply for a jobat GSK, please contact the GSK Service Centre at 1-877-694-7547 (USToll Free) or +1 801 567 5155 (outside US). GSK is an EqualOpportunity Employer and, in the US, we adhere to AffirmativeAction principles. This ensures that all qualified applicants willreceive 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 veteranstatus or any other federal, state or local protected class.Important notice to Employment businesses/ Agencies GSK does notaccept referrals from employment businesses and/or employmentagencies in respect of the vacancies posted on this site. Allemployment businesses/agencies are required to contact GSK'scommercial and general procurement/human resources department toobtain prior written authorization before referring any candidatesto GSK. The obtaining of prior written authorization is a conditionprecedent to any agreement (verbal or written) between theemployment business/ agency and GSK. In the absence of such writtenauthorization being obtained any actions undertaken by theemployment business/agency shall be deemed to have been performedwithout the consent or contractual agreement of GSK. GSK shalltherefore not be liable for any fees arising from such actions orany fees arising from any referrals by employmentbusinesses/agencies in respect of the vacancies posted on thissite. Please note that if you are a US Licensed HealthcareProfessional or Healthcare Professional as defined by the laws ofthe state issuing your license, GSK may be required to capture andreport expenses GSK incurs, on your behalf, in the event you areafforded an interview for employment. This capture of applicabletransfers of value is necessary to ensure GSK’s compliance to allfederal and state US Transparency requirements. For moreinformation, please visit the Centers for Medicare and MedicaidServices (CMS) website athttps://openpaymentsdata.cms.gov/#J-18808-Ljbffr
