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Clinical Sciences Program Lead (Oncology)

Employer
GSK
Location
Waltham, Massachusetts; Collegeville, Pennsylvania
Salary
Competitive
Closing date
Jan 16, 2021

View more

Discipline
Life Sciences, Oncology
Organization Type
All Industry, Pharma
Would you like to be a clinical science leader and part of GSK's exciting oncology clinical development organization?  If so, this could be an excellent leadership opportunity to explore.

It's a wonderful time to join our team as we discover and develop new oncology therapies with the life-changing potential of helping patients with cancer, specifically in four areas of cancer research: Cancer Epigenetics, Immuno-Oncology, Oncology Cell Therapy and Synthetic Lethality. Clinical Development at GSK is responsible for the development of the oncology portfolio from First Time In Human (FTIH) clinical trials to Proof-of-Concept studies, and pivotal registration trials.

Using your strong leadership, scientific and clinical research background, the Clinical Research/Sciences Leader partners with the physician leader to provide clinical science leadership and input on clinical and strategic issues that impact the progress and success of medicine development for patients.

We seek candidates with the following capabilities:

· Provide clinical science leadership, input, and oversight of multiple clinical studies either on a late stage asset or across multiple early phase clinical programs.

· Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature.

· Provide input on clinical development plans for Early Development or Medicine Development Teams.

· Line manage or mentor other clinical development scientists.

· Ensure high quality protocol development aligned with 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.

· 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.

· Summarize and provide 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.

· Partnering with the Physician Project Lead to ensure patient safety during the study lifecycle, and ensuring that study objectives fulfill regulatory and reporting requirements, and support medical governance (through the Medical Monitor/Physician Project Lead and other Study Team members/stakeholders, as appropriate). 

· 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).

· 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.

· 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.  Co-ordinates 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 and preferred advanced degree (e.g. MS, PhD, PharmD) with 10+ years of Pharmaceutical industry or relevant clinical experience.

· 2+ years of Oncology clinical development Director level leadership experience across a late stage asset or several early stage programs/studies, with preferred experience in immuno-oncology, cell and gene therapy, cancer epigenetics, or synthetic lethality.

Preferred Qualifications:

· Demonstrated leadership, mentorship, and influencing skills in a matrixed environment.

· 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.

· 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 and interpersonal skills appropriate to the target audience and senior stakeholders, promoting effective decision-making where necessary

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.

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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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