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.
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Position Summary
The Clinical DevelopmentMedicalDirector provides clinical and scientific insights and leadership to clinical and translational studiesor programsthat modulate vascularbiology and pathologywithin the Early Pipeline Unit(EPU)of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). Theappointed individualwillbe a subject matter expert in disease driven by vascular pathology.
Youwillwork within project teams toplan, execute, and deliver activities includingtranslational and clinical development strategiesand clinical studiesacross a range of therapy areaswith a focus ondisease driven by systemic inflammation and endothelial dysfunction. You will work cross-functionally to develop and execute clinical development plans up toandincludingproof-of-mechanism/proof-of-concept studies.
Key Accountabilities / Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following
1. Providescientific and clinical leadershiptostrengthen RIIRU’s capabilities in translation and early clinical developmentprograms that modulate inflammation and endothelial dysfunctionusing a range of drug modalities, including oligonucleotides,biologicsand small molecules.
2. Act as a subject matter expert in clinical development drugs that modulate inflammation and endothelial dysfunction.
3. Support thedesignoftranslational and clinical plansthatsupportproject strategy.Support theexecution ofhigh-qualityevidence-gathering and clinical development plansthatoffer swift paths tonew safe and effective medicines.Leaddevelopment of clinicalsections of core regulatory documents.
4. Contribute tothe design and execution of clinical studies that generate the data and evidencerequiredtodeterminea target or medicines’ potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possibletimeframe. This includes designingand deliveringthe clinicalelements of a translational strategy and designingand deliveringclinical development and study timelines and endpoints, including pharmacology,mechanismand clinical efficacy endpoints, enabling key decision points andgo/no-go criteria for theclinical development plan.
5. Seek,buildandmaintainrelationships with program counterparts inbiology,translational,commercial,research technologies,regulatory affairs,clinical operations,market access,medicalaffairsandstatistics.
6. Contribute tothe implementation and embedding of strategic initiatives and variousorganizationalinitiatives inclinical development
7. Provide effective support and oversight ofR&D evidence generation activities to assure patient safety and study delivery.
8. Contribute tostudy team discussions onindicationplanning,incorporates input from across disciplines (e.g. biology, clinical, commercial, regulatory, statistics) to contribute to vital deliverables including earlymedicine profile,target validation,translational plans,candidate selection.
9. Design clinical development plans and study protocols across all phases of development– with a focus on phases 1 and 2 –reflectinginternal and external stakeholder input (e.g.patients, evidence generation, regulators, payors, pharmacovigilance).
10. Developother asset- and study-related documents, including protocolamendments, investigator brochures, clinical study reports.
11. Provideclinical inputto regulatory interactions and documentsand responses to regulatory feedbackfor assigned studies and programs.
12. Provide medical monitoring and oversight of the safety of study participants on behalf of thesponsorduring the study, together withpharmacovigilance physician.Ifyou areaphysician,this includesaccountability formedical governanceacross the project to ensure scientific integrity and overall safety of the studyparticipants.
13. Be accountablefor leading theclinical matrix team (CMT)on EPU programs. Serve as a clinical point of contact both internally and externally(e.g. regulatory agencies, academic collaborators, investigators, external experts)forone or moreassetorindication,or for a clinical study. Represent the clinical matrix team atthe early development team (EDT)or clinical study at CMT.
14. Activelycollaborateto design and deliverthe end-to-end clinical development strategy forone or moreEPU programsand may contribute to laterclinical developmentstages.
15. Serve as the primary clinical interface with the relevant internal RIIRU/GSKgovernancereview boardsandprotocolreview board.
16. Contribute toclinicalevaluation of business development opportunities.
17. Gather and support the integration of inputs from across disciplines (scientific, clinical,commercial, regulatory) tocontribute toclinical components of themedicine profile. Consistentlycontribute tothesolvingofstudy and overall clinical development plan problems.
18. Demonstrate ability to influence others at project, departmental and inter-departmental levels, asappropriate.
19. Consistentlyinspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.
20. Demonstrate experience in managing conflicts effectively and independently, negotiating mutually acceptable solutions.
21. Consistently achieve desired outcomes through strong influencing skills including understanding others' perspectives, building trust, tailoring communications depending on the audience and using persuasive arguments to gain support.
22. Demonstrate flexibility and adaptability in changing environments, able to analyze incompleteor impreciseinformation,identifypotential risks and implications, and make informed decisions.
23. Demonstrate enterprise mindset with effective collaboration across the matrix, able to integrate cross-functional knowledge into decision-making processes and balance teamobjectiveswith the wider business goals.
24. Embrace challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areas
25. Proactivelygenerateideas for innovative improvement and takes advantage of opportunities that arise; promotes environment for others to generate ideas for improvement
Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
26. Medical degree from accredited medical school
27. Completion of a clinical residency program
28. Experience in clinical research and development
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
29. Board certification in internal medicine, cardiology, clinical pharmacology or a related specialty
30. Deep understanding of vascular medicine or vascular biology
31. Experience in translational and clinical research in vascular medicineallied toone or more internal medicine specialty(e.g. cardiology,metabolic medicine,nephrology, hepatology, neurology)either in a clinical academic setting or in a biotech or pharma organization.
32. Involvement incross-functionalmatrixteamsdesigning andexecuting clinical trialsto relevant regulatory standards.
33. Experience in contributing to NDA, BLA or MAA submissions
34. Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research
• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $222,750 to $371,250. • If you are based in another US location, the annual base salary range is $202,500 to $337,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
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.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.