Associate Director/Director Clinical Scientist, Oncology

2 months ago

Waltham, Massachusetts, United States GlaxoSmithKline Full time
Site Name: USA - Massachusetts - Waltham, Switzerland - Zug, USA - Pennsylvania - Philadelphia
Posted Date: Jul

This position will require 2 to 3 days per week onsite presence at our Waltham MA, or Upper Providence (Collegeville) PA or Zug Switzerland location.

The Associate Director/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 Associate Director/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.

Job Responsibilities:

The Associate Director/Director, Clinical Scientist, Oncology 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 target-based 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. 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:
  • Bachelor's degree in Life Science or equivalent within
  • 2 or more years work experience in Pharma industry or relevant clinical trial experience
  • 2 or more years Clinical trial and clinical research experience; running clinical trials in either the early or late phases
  • Experience working in a matrix management and large cross functional team environment
  • Experience generating clinical Protocols and ICFs
  • Experience working with data management and data cleaning of clinical data


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Advanced degree (e.g. MS, PhD, PharmD, RN, Nurse Practitioner) or equivalent experience (e.g. Study Coordinator at the site level)
  • Oncology or immuno-oncology experience preferred
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
  • Good communication skills appropriate to the target audience, promoting effective decision-making where necessary
  • Good 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
  • Good 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.
  • 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.
  • Good interpersonal skills
  • 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.


#LI-GSK

Please visit GSK US Benefits Summary t o 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 special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey 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 US Toll Free) or 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.

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.

  • Clinical Research Director

    17 hours ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job DescriptionDeciphera Pharmaceuticals is a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to improve the lives of people with cancer. We leverage our proprietary switch-control kinase inhibitor platform and expertise in kinase biology to develop a diverse portfolio of medicines.We are seeking an...

  • Senior Clinical Scientist

    6 days ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job DescriptionDeciphera Pharmaceuticals is a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to improve the lives of people with cancer. We leverage our proprietary switch-control kinase inhibitor platform and expertise in kinase biology to develop a diverse portfolio of medicines.We are seeking an...

  • Medical Director

    19 hours ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly skilled Medical Director to join our Oncology Clinical Development team at GlaxoSmithKline. As a Medical Director, you will be responsible for leading clinical research activities and developing innovative medicines to improve patient outcomes.Key ResponsibilitiesCollaborate with cross-functional teams to develop and...

  • Associate Director, Clinical Pharmacology

    2 months ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date: Jul GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing...

  • Quantitative Clinical Pharmacologist

    3 days ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly motivated and experienced Quantitative Clinical Pharmacologist to join our team as a Manager or Associate Director in the Clinical Pharmacology Modelling and Simulation (CPMS) department. As a key member of our team, you will be responsible for delivering clinical pharmacology and modelling & simulation excellence to...

  • Associate Director

    2 months ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Jul The Associate Director of Analytical Development will lead a team of analytical scientists responsible for development, manufacturing, release and stability testing, and characterization of drug substances/API and drug products of...

  • Associate Director, Clinical Operations

    4 weeks ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals, Inc Full time

    Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch–control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by our proprietary...

  • Lead Scientist in Biotherapeutics Engineering

    2 weeks ago

    Waltham, Massachusetts, United States Xilio Therapeutics Full time

    Principal Scientist / Associate Director – Biotherapeutics EngineeringXilio Therapeutics is a pioneering biotechnology firm focused on the discovery and advancement of tumor-activated immuno-oncology therapies. Our mission is to enhance the quality of life for cancer patients by minimizing the systemic side effects associated with conventional...

  • SVP/VP/Exec Director Clinical Development

    1 month ago

    Waltham, Massachusetts, United States Professional Diversity Network Full time

    Job#: Job Description: SVP/VP/Exec Director Clinical Development – Immuno–OncologyLocation:Waltham, MA (Hybrid)Therapeutic Area:Immuno–OncologyJob Overview:This role is for a knowledgeable and experienced individual to support clinical stage activities, responsible for developing efficient strategies and coordinating medical activities for clinical...

  • Regulatory Affairs Director

    4 days ago

    Waltham, Massachusetts, United States Muraloncology Full time

    About the RoleMuraloncology is seeking a highly skilled and experienced Regulatory Affairs Director to lead our Regulatory Strategy team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support the approval and commercialization of our oncology products.Key...

  • Director, Quantitative Systems Pharmacology Expert

    3 days ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly motivated and experienced Director-level Quantitative Systems Pharmacology (QSP) Expert to join our team at GlaxoSmithKline. As a key member of our Clinical Pharmacology Modelling and Simulation (CPMS) department, you will play a critical role in delivering CPMS excellence to research and development programs using...

  • Facilities Director

    5 days ago

    Waltham, Massachusetts, United States TScan Therapeutics Full time

    About the RoleTScan Therapeutics is seeking an experienced professional to join our team as a Facilities Director/Director of Engineering and Operations. This key role will support the startup, certification, and ongoing production and maintenance of our clinical GMP manufacturing facility and the operation of our R&D facility.ResponsibilitiesSupport the...

  • Associate Director, Medical Expert Engagement Marketer

    2 months ago

    Waltham, Massachusetts, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...

  • Director of Engineering and Operations

    6 days ago

    Waltham, Massachusetts, United States TScan Therapeutics Full time

    About the RoleTScan Therapeutics is seeking an experienced professional to join our team as a Facilities Director/Director of Engineering and Operations. This key role will support the startup, certification, and ongoing production and maintenance of our clinical GMP manufacturing facility and the operation of our R&D facility.ResponsibilitiesSupport the...

  • Associate Director Clinical Portfolio Execution

    3 days ago

    Waltham, Massachusetts, United States CSL Behring Full time

    About the RoleCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. Our company is committed to delivering medicines that improve their lives.We are seeking an experienced Associate Director Clinical Portfolio Execution to join our...

  • Medical Director

    4 days ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Job SummaryThis is a high-impact position with great visibility across all levels of the Alkermes organization. The successful candidate will have critical responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders.Key ResponsibilitiesDevelop and implement clinical research...

  • Associate Director, Vaccine Epidemiology Strategy

    4 days ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    About the RoleWe are seeking a highly skilled Associate Director to lead our Vaccine Epidemiology team in driving epidemiology strategy and studies across the spectrum of vaccine development. As a key member of our team, you will be responsible for developing and implementing epidemiological activities to support our vaccine development process.Key...

  • Associate Director, Human Research Protection Program

    3 weeks ago

    Waltham, Massachusetts, United States tapwage Full time

    Brandeis University is delighted to announce a career opportunity for an Associate Director, Human Research Protection Program (HRPP) in the Office of Research Administration. If you are looking for an opportunity to work at a beautiful university campus with lots of perks including free parking and access to a top of the line athletic facility, look no...

  • Associate Director, Clinical Data Analyst

    3 months ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Principal Research Scientist I, Oncology Biomarkers

    1 month ago

    Waltham, Massachusetts, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...