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Clinical Development / Clinical Scientist (Oncology)

Employer
GSK
Location
Philadelphia, Pennsylvania
Salary
Competitive
Closing date
Oct 20, 2021

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Sector
Science, Pharmaceutical
Jobseeker Type
Professional
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Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Oct 1 2021 The Clinical Scientist has accountability for providing scientific input during protocol development, oversight of study conduct, and interpretation of study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. The Clinical Scientist will lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfill regulatory and reporting requirements, and support medical governance (through the Medical Monitor/Physician Project Lead (PPL) and other Study Team members/stakeholders, as appropriate). The Clinical Scientist is also Responsible for design and execution in collaboration Medical Monitor for multiple-phase studies. The Clinical Scientist will effectively engage and influence a diverse scientific community of internal and external experts, including collaborations. Further to study/project accountability, the Clinical Scientist may manage other staff within Clinical Sciences. Job Responsibilities: The Clinical Scientist responsibility includes, but is not limited to: • Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study • Lead or Contribute as appropriate to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisions. • Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and targetbased literature • Integrate data from internal, and external academic, conference and competitor sources • Understand and support creation and support of competitor landscape, medical need, regulatory strategy • Appropriately interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc. • Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan (CDP) • Ensure the high quality of protocol documents are developed aligned to the CDP to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe • Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents • Develop studies in accordance with current GSK policies and procedures • As appropriate, Lead Clinical Matrix Teams Accountabilities: • Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP • Understands objectives; safety, efficacy, statistical endpoints; epidemiological and operational elements; the biology, pharmacology and toxicology; data driven phenotypes identification, biomarkers, microbiology, virology • Authors the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetings • Ensures study protocol reflects input from internal and/or external experts/thought leaders • Liaises with all functions as appropriate to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible • Provides input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM) • Contributes to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.) • Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc. • If Internal Safety Review Committee (ISRC)/IDMC data review is required, participates in, or leads identification of internal or external ISRC/IDMC members, respectively and preparation of charter. Coordinates with Medical Monitor/PPL and other Study Team members and stakeholders. • Identifies and ensures the review of critical safety datasets for in-stream data review in line with Medical Governance objectives (through Medical Monitor/PPL and other stakeholders, as appropriate) • Participates in eCRF development and may participate in UAT • Reviews the reporting and analysis plan (RAP) and advises on required outputs • Participates in data review ongoing through study including interim analyses, in-stream data review, etc. • Responsible for ensuring the Go/No-Go criteria have been set for the study • Presents the scientific rationale and study design at Investigator Meetings and responds to scientific questions arising from sites during study conduct • Ensures prompt, quality communications with sites regarding protocol clarification and procedural queries • Ensures completion of medical governance (through a physician on the team) and regulatory reporting at the start to ensure overall safety of the study subjects • Interpretation of study data and scientific content of clinical study reports (CSRs) and regulatory submissions • Ensures CSR and other documents reflect input from internal and/or external experts/thought leaders as appropriate • Understands and anticipates questions from internal and/or external stakeholders regarding data results • Working with the PPL and other stakeholders, clearly communicates results to internal and external stakeholders and regulators • Drives content of other clinical documents (e.g. Investigator Brochure); regulatory documents input (e.g. DSURs, BRMP, DCSI, Annual Safety Reports, PBRs, etc.) • Knowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatory interactions/approvals and active attendance at IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, AdCom meetings • Leads completion/filing of key components of clinical modules (NDA/BLA/MAA, AdCom prep, Scientific Advice) for marketing authorization • Prepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publications • Inputs into the organisation of Advisory boards and other scientific engagement activities. • Delivers of end-of-study reports and publication/presentation of results • Reviews/evaluates external collaborations (e.g. SCS, ISS) Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: • Basic Life Science degree or equivalent and 5+ years of industry or relevant clinical experience • Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution • Broad understanding of the pharmaceutical industry and the clinical development process • Clinical training and/or applicable clinical research experience; understanding of running clinical trial from concept study idea to publication • Matrix management experience; 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 • Good interpersonal relationship building/maintenance Preferred Qualifications: If you have the following characteristics, it would be a plus: • Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience • Oncology or immuno-oncology experience • Excellent leadership and influencing skills • Experience taking strong cross functional leadership role in clinical development; experience & understanding of clinical development from early stage through to regulatory submission and market support • Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes. • Understands the study, project, and program level and can function successfully across a variety of projects. • Understands the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery. • Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support. • Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment. 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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