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Medical Director/Senior Medical Director - Oncology Clinical Development - Multiple Myeloma

Employer
GSK
Location
Collegeville, Pennsylvania; Waltham, Massachusetts
Salary
Competitive
Closing date
Sep 25, 2022

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Are you keen to join an oncology clinical development organization paving the way to improve the lives of patients with multiple myeloma? If so, then this Medical Director role at GSK is one to consider.

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.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude , our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D .

Annual Report 2021

Product Pipeline

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 individual will also have a leading role in managing effective relationships with Key External Experts.

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.

Depending on experience, this role may be graded at a Senior Medical Director level.

Job Responsibilities:
  • 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
  • Ensure 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.
  • #LI-GSK
  • #LI-Hybrid


Why you?

Basic Qualifications:
  • MD (or equivalent) with board certification or board qualifications in medical oncology.
  • Experience in pharmaceutical/biotechnology industry or related clinical experience
  • Documented academic and/or clinical research publication history or history of medical practice in a relevant field.
  • Strong working knowledge 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


Preferred Qualifications:
  • Solid personal and professional relationships with key opinion leaders (KOLs) in medical oncology. Strong credibility within the medical community which includes the ability to reach out to key thought leaders in academia


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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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.
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