Director Clinical Scientist- Oncology
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more:
The Director, Clinical Scientist- Oncology has accountability for providing clinical 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 Director, Clinical Scientist, Oncology will lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfil regulatory and reporting requirements, and support medical governance (through the Medical Director and/or the Clinical Development Lead; and other Study Team members/stakeholders, as appropriate). The role is also responsible for designing and executing, in collaboration with the Medical Director, the clinical trial(s) assigned to the project. This role 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.
Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham. MA or Boston. MA); or Poland (Warsaw).
Responsibilities
The Director, Clinical Scientist, Oncology responsibilities include, but are not limited to:
1. Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study
2. 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.
3. Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature
4. Integrate data from internal, and external academic, conference and competitor sources
5. Understand and support creation and support of competitor landscape, medical need, regulatory strategy
6. Appropriately interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc.
7. 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)
8. 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
9. 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
10. Develop studies in accordance with current GSK policies and procedures
11. As appropriate, Lead Clinical Matrix Teams
Accountabilities:
12. Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP
13. Understands objectives; safety, efficacy, statistical endpoints; epidemiological and operational elements; the biology, pharmacology and toxicology; data driven phenotypes identification, biomarkers, microbiology, virology
14. Authors the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetings
15. Ensures study protocol reflects input from internal and/or external experts/thought leaders
16. Liaises with all functions as appropriate to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible
17. 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)
18. Contributes to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.)
19. Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.
20. 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. Co-ordinates with Medical Monitor/PPL and other Study Team members and stakeholders.
21. 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)
22. Participates in eCRF development and may participate in UAT
23. Reviews the reporting and analysis plan (RAP) and advises on required outputs
24. Participates in data review ongoing through study including interim analyses, in-stream data review, etc.
25. Responsible for ensuring the Go/No-Go criteria have been set for the study
26. Presents the scientific rationale and study design at Investigator Meetings and responds to scientific questions arising from sites during study conduct
27. Ensures prompt, quality communications with sites regarding protocol clarification and procedural queries
28. 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
29. Interpretation of study data and scientific content of clinical study reports (CSRs) and regulatory submissions
30. Ensures CSR and other documents reflect input from internal and/or external experts/thought leaders as appropriate
31. Understands and anticipates questions from internal and/or external stakeholders regarding data results
32. Working with the PPL and other stakeholders, clearly communicates results to internal and external stakeholders and regulators
33. Drives content of other clinical documents (e.g. Investigator Brochure); regulatory documents input (e.g. DSURs, BRMP, DCSI, Annual Safety Reports, PBRs, etc.)
34. 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
35. Leads completion/filing of key components of clinical modules (NDA/BLA/MAA, AdCom prep, Scientific Advice) for marketing authorization
36. Prepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publications
37. Inputs into the organization of Advisory boards and other scientific engagement activities.
38. Delivers of end-of-study reports and publication/presentation of results
39. Reviews/evaluates external collaborations (e.g. SCS, ISS)
Why you?
Basic Qualifications:
40. Bachelor’s degree in Life Science or equivalent
41. 2 or more years work experience in Pharma industry or relevant clinical trial experience
42. 2 or more years Clinical trial and clinical research experience; running clinical trials in either the early or late phases
43. Experience working in a matrix management and large cross functional team environment
44. Experience generating clinical Protocols and ICFs
45. Experience working with data management and data cleaning of clinical data
Preferred Qualifications:
46. Advanced degree (e.g. MS, PhD, PharmD, RN, Nurse Practitioner) or equivalent experience (e.g. Study Coordinator at the site level)
47. Oncology or immuno-oncology experience preferred
48. Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
49. Good communication skills appropriate to the target audience, promoting effective decision-making where necessary
50. Good knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
51. Broad understanding of the pharmaceutical industry and the clinical development process
52. Good leadership and influencing skills
53. 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.
54. Understands the study, project, and program level and can function successfully across a variety of projects.
55. Understands the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery.
56. Good interpersonal skills
57. Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
58. Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change
59. Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
Join us in shaping the future of clinical development and making a meaningful impact on patients' lives.
Please visit 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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.