Medical Director- Oncology Clinical Development- Synthetic Lethality - Waltham, MA, United States - GlaxoSmithKline

Description

Are you an Oncology clinical research physician with an interest to expand your reach for improving patients' lives who have cancer with a company emerging with innovative medicines? If so, this Medical Director opportunity may be of interest to you.

GSK ONCOLOGYOur Oncology R&D organization is building a diverse portfolio of Oncology medicines, focused on maximizing patient survival through transformation medicines.

We aim to deliver first-to-market and first-in-class solutions that have the potential to address some of the biggest challenges in oncology.

Our organization covers the entire research and development spectrum from discovery to clinical development and regulatory compliance.

We partner with other R&D functions, including Commercial and Medical to build our pipeline, manage trials, and progress from development to commercialization.

We also pursue and manage critical business development opportunities, collaborations and acquisitions to advance our mission.

​​GSK continues to be committed to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer:

• Immuno-Oncology - Focused on an innovative pipeline of immune modulators designed to leverage a patient's immune system to recognize and eradicate solid and liquid tumors.
• Tumor Cell Targeting - Target tumor-specific alterations to introduce selective anti-cancer activity.
• Synthetic Lethality - Optimizing the use of PARP-inhibitors and delivering a Repertoire of Synthetic Lethal Medicines

Pipeline link:
The Medical Director Oncology Clinical Development will report to the Group Sr. Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development.

The 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 scientific and medical leaders in order to lead clinical data generation activities.

This role requires a physician 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.

Key ResponsibilitiesCollaborate 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 trialsEnsure high quality protocol development 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.
Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature. Serve as a core member of the Clinical Matrix Team for one or more assets in development.
Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.


Basic Qualifications:

Experience in pharmaceutical/biotechnology industry or related clinical experienceMD (or equivalent) with board certification/qualifications/registration (or equivalent) in medical oncology,hematology or internal medicineExperience in lung cancer field.

Documented academic and/or clinical research publication history or history of medical practice in a relevant field.

PhD degreeExperience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development processRobust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution Understanding of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.

Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles*LI-GSKWhy GSK?We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why.

We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

No single scientist, nor any one technology can keep us all ahead of disease.

That's why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead.

In the past three years, we've doubled the number of partnerships we've signed, because of our belief in their significant impact on our process.

Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas.

Many have the potential to be first or best-in-class opportunities for patients and since 2017, we've delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do the most good. If a project doesn't pan out, we take what we've learned and apply it elsewhere.

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.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

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.

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.

Full time