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Medical Director - Oncology Clinical Development - niraparib (new indications)

Company: GlaxoSmithKline
Location: Waltham
Posted on: September 12, 2020

Job Description:

Medical Director - Oncology Clinical Development - niraparib (new indications) Waltham, Massachusetts; Stevenage, United Kingdom; Collegeville, Pennsylvania

Medical and Clinical

257105

Job description Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham

Posted Date: Jun 30 2020

Does it excite you and have you committed your career next step to be in the forefront of maximizing patient survival through transformational oncology medicines ? If so, this Medical Director position is an excellent opportunity to explore. GSK Oncology R&D is focused on building industry-leading portfolios in four cutting-edge areas of science:

• Immuno-Oncology : using the human immune system to treat cancer

• Cell/Gene Therapy : engineering human T-cells to target cancer

• Cancer Epigenetics : modulating the gene-regulatory system of the epigenome to exert anti-cancer effects

•  Synthetic Lethality : targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer

The Medical Director as a study physician 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 Opinion Leaders.

Job Responsibilities:

Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others as necessary to develop and execute clinical trials from beginning to end. Contribute to ongoing or planned interventional clinical trials (phase 1-3)

Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.

In collaboration with clinical teams, drive clinical trial execution to achieve timely completion and to ensure scientific integrity of clinical studies.

Conduct safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies.

Analysis, interpretation and presentation of clinical study data.

Participate in authoring of regulatory documents and Collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.

Participate in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data

Collaborate with Principal Investigators in generation 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.

Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate.

For additional information, please visit:

https://us.gsk.com/en-us/careers/a-career-in-oncology/

GSK's Oncology Transformation: https://bit.ly/2zTytwmon https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001

ASCO Highlights/Endorsements: https://www.gsk.com/en-gb/media/press-releases/gsk-highlights-scientific-innovation-and-advances-in-its-growing-oncology-portfolio-at-asco-2020/#

*LI-GSK

Why you? Basic Qualifications: MD (or equivalent) with board certification or board qualifications in medical oncology. US State License to practice medicine is desirable

At least 3 years of clinical development experience within the pharmaceutical or biotechnology industry with focus and strong track record of experience with leading oncology clinical trials. Alternatively, academic professional experience with significant clinical research activity or robust medical affairs background in Oncology will be considered.

Strong working knowledge of the clinical drug development process. Track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.

Successful academic research publication history or history of medical practice in a relevant field.

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

Preferred Qualifications: Board certification/eligibility, and clinical experience in oncology or hematology/oncology preferred

A strong professional track record and clinical research experience in colon-rectal, Breast or brain cancer.

Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.

Managing individual performance.

Creating a performance culture and driving results, prioritisation, execution, delivering performance.

Setting strategic direction and leading on-going organisational transformation.

Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.

Managing P&L and capital allocation.

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.

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.

Medical Director - Oncology Clinical Development - niraparib (new indications) Full-Time, Waltham, Massachusetts, United States Medical Director - Oncology Clinical Development - niraparib (new indications) Full-Time, Waltham, Massachusetts, United States Are you looking for an exciting and rewarding career in Oncology? Our Oncology unit is growing and is driven by its own collaborative team of research, development and commercially facing roles united in a single goal – to play a part in helping patients with cancer.

We are looking for exceptional talent to join our teams in Boston, Philadelphia and San Francisco.

Keywords: GlaxoSmithKline, Waltham , Medical Director - Oncology Clinical Development - niraparib (new indications), Other , Waltham, Massachusetts

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