Director, Discovery Medicine, Hepatology
The Discovery Medicine (DM) Physician is recognized internally and external to GSK as a leader in Drug Development and Translational Medicine and/or as an expert in his or her disease/therapeutic area, in this case Hepatology. The DM Physician will be expected to have a thorough understanding of the asset(s) they are working on, the biological mechanism(s) of action and relevant disease indications.
Accountabilities will include provision of medical and scientific input into the design of one or more clinical studies within CPEM and support and advice to the Research Units relating to specific diseases, development feasibility and potential strategies for early clinical development of compounds prior to candidate selection. You will be responsible for design and delivery of the early Clinical Development Plan (CDP), working with the EDL, project team and study teams, to deliver data that will support progression to full development of the medicine.
The DM Physician will also provide clinical support/leadership for proof of mechanism studies (POM) for compounds in Development. You will be accountable for medical governance and regulatory reporting at the project level (and in support of the Clinical team) through clinical interpretation of data (clinical and non-clinical) that can impact patient safety and clinical efficacy. Working closely with the Clinical Scientist they will ensure that there is complete data package to support the above studies (PK, translational biology, potency etc).
To succeed, you will also need to work closely with a broad matrix team of project representatives and in some cases, external collaborators.
The responsibilities of the DM Physician include the following:
1. Strategy and Matrix leadership
a. Accountable for design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development.
b. Accountable for creation of the Clinical Section and input into other sections of the Technical Evidence document for Candidate Selection
c. Leads the Clinical Matrix Team (CMT) (or equivalent cross-functional clinical team))
d. Accountable for providing clinical input into CMC plans, ensuring that any considerations around administration (e.g. compatibility testing of delivery sets, production of placebo) for Phase I studies are highlighted, and inputting into the supply demand forecast and strategy.
e. Responsible for liaising with Biomarker rep to ensure that a biomarker strategy is in place and that appropriate assays are available/developed to support the clinical studies.
f. Responsible for liaising with the Translational Biologist on the team to ensure that the appropriate data-package has been generated to support the proposed indications.
g. Accountable for ensuring that any enabling work (e.g. challenge models, method development) to support the Clinical Development Plan (CDP) has been completed.
h. Accountable for leading study team preparation and delivery for GSK safety panels and GSB reviews.
i. Accountable for engaging external academic and clinical experts to enhance quality and delivery of discovery medicine studies.
j. For projects prior to candidate selection physician clinical input may be direct or via the supervision of clinical scientists.
2. Medical governance
a. Accountable for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy (i.e. Manufacturing, formulation, etc).
b. Accountability for providing clinical input into presentations, supporting documentation for and participation in RRB/RIB.
c. Accountable for escalation of clinical safety incidents to DM head, as appropriate.
3. Study design, protocol development, execution and reporting:
a. contributes to protocol development and is accountable for technical approval of the final protocol.
b. accountable for reviewing and approving the global Informed Consent Form (ICF).
c. contribute to the development of other study documents including but not limited to the safety management plan (SMP), study reference manual (SRM), reporting and analysis plan (RAP), protocol deviation management plan (PDMP) and study risk register.
d. Accountable for ensuring the Go/No-Go criteria have been set for the study.
e. Reviews the reporting and analysis plan (RAP) and advises on required outputs.
f. Contributes to data review and instream cleaning, data analysis and reporting
g. Accountability for leading dose-escalation meetings and decision-making for Phase 1 studies.
h. Accountable for medical monitoring of DM studies
i. responding to queries from investigators and sites regarding study-related medical issues including inclusion/exclusion criteria.
ii. Accountable for reviewing and assigning importance to protocol deviations
iii. Accountable for creating the Dose Escalation Team charter and leading Dose Escalation Meetings
a. Accountable for providing oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Physician, providing input into aspects of study design that relate to subject safety.
b. Working together with CPMS and Safety Physician to selecting study population, starting dose, dose escalation and designs that are appropriate for the risk/benefit profile of the asset.
c. Work with Safety Physician in the development/review of Dear Investigator Letters (DIL), review of safety data post study, and mitigation strategies for BRMP risks
d. Accountable for safety monitoring of DM studies
i. Evaluating safety events reported from sites, including SAEs, and AEs and laboratory values of concern.
ii. Escalating reports of important safety events in a timely manner
iii. Assisting the Safety Physician with the presentation of information regarding SAEs and other relevant study events to the SRT.
iv. Responsible for providing essential safety training at Investigator Meetings.
a. Accountable for clinical and risk/benefit sections of regulatory documentation to support the desired indication (e.g., IB, IMPD)
b. Accountable for responding to questions from regulatory authorities and ethics committees that relate to clinical conduct and safety.
c. Responsible for addressing clinical questions at meetings with regulatory authorities/ethics committees
d. Accountable for regulatory reporting requirements including Development Safety Update Reports (DSUR's) and IB updates
a. Transition to Development organisation- Interactions with MDL and PPL for smooth transition of programmes
b. Patient perspective - accountable for incorporating patient perspective in the design and conduct of DM studies.
To be considered as a senior level experienced physician you will be highly experienced in drug development or translational medicine. You will be expected to work across multiple DM projects, demonstrating independent accountability for their projects. You will set long term scientific strategy and be capable of executing this strategy based on their own expertise and that gained from their network.
May play a leadership role in;
• Medical governance initiatives in R&D (eg safety panel or governance board).
• Discovery/development policy, processes or guidelines affecting the pharmaceutical industry.
• Training networks in/outside of GSK
• Business development activities in DM
• May have line management responsibilities within Discovery Medicine including recruitment, setting objectives, driving performance and building development plans.
• Will play an active role in mentoring and coaching other members of DM
• Applies extensive knowledge of clinical development to more than one research unit/disease area.
• Builds an external network with academia/pharma, bringing expertise and knowledge back to GSK. Anticipates, communicates and takes action on trends/events outside GSK that affect our business direction.
• Uses command of the drug discovery and development process to influence a culture of continuous improvement
• Board certified Hepatologist
• Clinical experience
• Experience in Hepatitis and liver disease
• Experience in early stage drug discovery and early phase drug development
• Medical monitoring experience
• Knowledge of clinical trial conduct and regulatory activities
• Ability to interpret clinical trial results, including the strengths and weaknesses of study design and application of study results to clinical practice.
• Breadth of clinical knowledge
• MD PhD
• Credibility in working with external clinical partners with evidence of solid external clinical network within Hepatology.
GlaxoSmithKline (GSK) is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.
The company has a significant global presence with operations in more than 150 countries, a network of 87 manufacturing sites in 36 countries, and large R&D centres in the UK, USA and Belgium.
The three main business areas are:
• Pharmaceuticals - The Pharmaceuticals business discovers, develops and makes medicines to treat a broad range of the world's most common acute and chronic diseases. The business generated sales of £17.3 billion in 2018. The business is made up of innovative and established medicines and holds leading positions in respiratory disease and HIV. The Pharmaceuticals R&D organisation seeks to understand how the immune system causes disease in a therapeutic agnostic manner as well as using human genetics and investments in advanced technologies to advance our research.
• Vaccines - The Vaccines business has the broadest portfolio of any company, with vaccines for people of all ages. GSK delivers over two million vaccine doses per day to people across over 160 countries. The Vaccines business has a portfolio of 41 paediatric, adolescent, adult, other people and travel vaccines that offer protection against 22 different diseases. There is a pipeline of 14 candidate vaccines in early, mid and late stage development against a range of diseases. This pipeline of potential new vaccines covers many of the diseases still having a serious impact around the world, including malaria, HIV, TB and Ebola. In 2017, the business contributed £5.9 billion to the overall turnover of the Group.
• Consumer Healthcare - In December 2018, it was announced that our Consumer Healthcare business will enter into a joint venture with Pfizer which will have combined sales of approximately £9.8 billion. This combined group will bring together two highly complementary portfolios of trusted consumer health brands, including GSK's Sensodyne, Voltaren and Panadol and Pfizer's Advil, Centrum and Caltrate. The Joint Venture will be a category leader in Pain Relief, Respiratory, Vitamin and Mineral Supplements, Digestive Health, Skin Health and Therapeutic Oral Health.
You may apply for this position online by selecting the Apply now button.
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