Talent.com
GSK
Senior Medical Director, Oncology Clinical Development (GU)GSK • Stevenage, United Kingdom
Senior Medical Director, Oncology Clinical Development (GU)

Senior Medical Director, Oncology Clinical Development (GU)

GSK • Stevenage, United Kingdom
27 days ago
Job type
  • Full-time
Job description
Senior Medical Director, Oncology Clinical Development - GU
The Senior Medical Director, Oncology Clinical Development - GU will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Sr. Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant internal scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires an experienced professional capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s Switzerland (Zug), Poland (Warsaw), UK (Stevenage or London HQ) or US (PA or MA) sites.

KEY RESPONSIBILITIES:
  • Exhibit leadership at the program and cross-functional level and collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
  • Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
  • Oversee the development of high-quality protocols aligned with the Clinical Development Plan to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
  • Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
  • Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
  • Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.
  • Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
  • Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
  • Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
  • Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK’s vision.
  • Contribute to the clinical and technical diligence assessment of business development opportunities, as needed.
  • Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
  • Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate.
  • Serve as a core member of the Clinical Matrix Team for one or more assets in development.
  • Lead Oncology Clinical Development-wide initiatives and workstreams as appropriate.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
  • Medical degree and completion of advanced specialty training, fellowship or country-equivalent higher-level qualification in Medical Oncology, Radiation Oncology, Urology or Internal Medicine (with GU or oncology experience).
  • Experience in the global pharmaceutical/biotechnology industry in the field of GU prostate cancer.
  • Experience leading GU Oncology drug development, including Phase 1, 2 and 3 clinical trial design, initiation, execution, and closure.
  • Academic and/or clinical research publication history or history of medical practice in GU Oncology.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:
  • PhD in addition to medical degree and completion of advanced specialty training, fellowship or country-equivalent higher level qualification.
  • Established personal and professional relationships with key external experts (KEEs) in medical oncology and credibility within the medical community.
  • Experience in the clinical assessment of business development opportunities to expand a growing portfolio
  • Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
  • Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
  • Highly developed communication and interpersonal skills appropriate to the target audience and senior stakeholders, promoting effective decision-making in a highly matrixed environment
  • Demonstrated track record of quality decision-making and innovative problem resolution in critical situations
  • Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles.

Skills
Clinical Data Interpretation, Clinical Pharmacology, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Development, Drug Regulatory Affairs, Evidence Based Decision Making, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations, Strategic Direction
Create a job alert for this search

Senior Medical Director, Oncology Clinical Development (GU) • Stevenage, United Kingdom

Similar jobs

Clinical Director

The Adecco GroupWelwyn, England, United Kingdom
Temporary

Job Opportunity: Medical Director (Contractor) – Neurodegeneration.As the Medical Director, you will play a pivotal role in supporting late‑stage clinical projects aimed at addressing significant u... Show more

 • Promoted

Medical Director UK

Accord HealthcareUxbridge, England, United Kingdom
Full-time

The Medical Director will join the Senior Director of Speciality Brands' team here in Stockley Park.This role will have overall UK country-level responsibility for medical affairs activities across... Show more

 • Promoted

Strategic Healthcare Growth Director

HUCHatfield, England, GB
Full-time

HUC is seeking a Development Director to drive growth, secure new business, and shape service models across local and national healthcare systems.You will lead strategic initiatives, oversee commer... Show more

 • Promoted

Associate Director Global Patient Safety

RegeneronUxbridge, England, GB
Full-time

At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases.We are seeking an Associate Director, PV Case Operations to join our Global Patient S... Show more

 • Promoted

Clinical Director

SEC Life SciencesWelwyn Garden City, England, United Kingdom
Full-time

Medical Director - Neurodegenerative Diseases (Alzheimer's Disease).Hybrid - 2 days per week onsite (Welwyn Garden City area).An innovative global biopharmaceutical organisation is seeking an exper... Show more

 • Promoted

Senior Medical Director, Early Clin Dev (Remote UK)

BioMarin Pharmaceutical Inc.Luton, England, United Kingdom
Remote
Full-time

Senior Medical Director, Early Clinical Development to shape and execute clinical strategies for early-stage assets.This role involves leading clinical trials from the initial phases through proof ... Show more

 • Promoted

UK Medical Affairs Director: Strategy, Leadership & Growth

Accord HealthcareUxbridge, England, United Kingdom
Full-time

Accord Healthcare in the UK seeks a Medical Director to join the Senior Director of Speciality Brands' team at Stockley Park.You will assume country-level responsibility for medical affairs across ... Show more

 • Promoted

Development Director

HUCHatfield, England, GB
Full-time

Are you a commercially astute leader with a passion for healthcare innovation and system-wide transformation? HUC is seeking an ambitious Development Director to drive our next phase of growth, hel... Show more

 • Promoted

Senior Medical Science Liaison – Cardiovascular, UK North

RecordatiHemel Hempstead, England, GB
Full-time

Recordati is expanding its UK SPC team and seeks a Medical Science Liaison (MSL)/Senior MSL for the North of the UK.This field‑based role supports medical engagement, education and evidence generat... Show more

 • Promoted

Ophthalmology Precision Medicine Lead - Medical Director

F. Hoffmann-La Roche AGWelwyn, England, United Kingdom
Full-time

Ophthalmology Precision Medicine function from the ground up, defining vision, structure, and scientific direction across biomarkers, imaging, clinical science, and AI.You will lead a cross‑functio... Show more

 • Promoted

Senior Manager Clinical Study Lead

PharmiWeb.jobs: Global Life Science JobsUxbridge, England, GB
Full-time

CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to st... Show more

 • Promoted

Advanced Clinical Practitioner

Resourcing GroupLuton, ENG, GB
Full-time

Connaught Resourcing is actively seeking Urgent Care Practitioners - ACPs and ECPs for our client in Bedfordshire for work within Urgent Treatment Centres and GP OOHs.We are able to offer up to ful... Show more

 • Promoted

Strategic Account Director, Med Comms (Oncology) | Hybrid

RBW Consulting LLPLetchworth, England, GB
Full-time

RBW Consulting LLP is seeking an experienced Account Director to lead significant accounts in healthcare communications.This role involves driving client success, shaping strategy, and fostering co... Show more

 • Promoted

Clinical Director Vet — Lead Small Animal Care & Growth

MygotovetLuton, England, GB
Full-time

A veterinary practice in Luton is seeking a Clinical Director to lead and mentor a team dedicated to veterinary care.The role offers a competitive salary and benefits including flexible hours, gene... Show more

 • Promoted

Account Director Med Comms, London

RBW Consulting LLPLetchworth, England, GB
Full-time

Are you ready to make a lasting impact in the world of healthcare communications? This is your chance to join a forward-thinking team as an Account Director, where you'll take the lead on significa... Show more

 • Promoted

Commercial Director

HaysHuntingdon, ENG, GB
Permanent

Your new company You'll be joining a long-established construction group with nearly four decades of growth, now operating hundreds of HGVs across multiple sites and employing a large, diverse ... Show more

 • Promoted

Senior Medical Director, Alzheimer's & Neurodegenerative CNS

SEC Life SciencesWelwyn Garden City, England, GB
Full-time

A biopharmaceutical organization based in the UK is looking for an experienced Medical Director specializing in neurodegenerative diseases, particularly Alzheimer's.This hybrid role involves suppor... Show more

 • Promoted

Global Clinical Director, Hematology & Cell Therapy

Bristol Myers SquibbDenham, England, GB
Full-time

Bristol Myers Squibb is looking for a Director, Global Clinical Physician to lead the medical and scientific aspects of clinical development for hematology, oncology, and cell therapy.This role inv... Show more

 • Promoted

Global Brand Director - Paediatric Oncology

NorgineUxbridge, England, GB
Full-time

A global biopharmaceutical company is seeking a Senior Global Brand Director for the Paediatric Oncology portfolio.This position is vital for leading the strategic vision and execution of brand str... Show more

 • Promoted

Senior Global Brand Director - Rare Disease

NorgineUxbridge, England, GB
Full-time

Senior Global Brand Director - Rare Disease.Norgine Uxbridge, England, United Kingdom.Norgine and it offers you a fully-rounded experience with no limits.Bring everything about yourself that you're... Show more