Nazwa biura: USA - Pennsylvania - Pennsylvania Central, Stevenage, Switzerland - Zug, UK - London, USA - Massachusetts - Boston, Warsaw
Posted Date: Dec
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:
GSK Oncology Clinical Development is seeking a highly skilled and motivated Clinical Development Medical Director- Oncology, to join our dynamic Oncology Research and Development team. In this role the successful candidate will create a strong link between Clinical Development and other functions in the clinical matrix team to increase the success of our Oncology clinical portfolio in the GU cancer space.
The Clinical Development Medical Director- Oncology will report to the Executive Medical Director, Clinical Development Lead (CDL)-GU, 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 for patients with prostate cancer.
Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham, MA); or Poland (Warsaw).
Key responsibilities:
* Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute early phase interventional clinical trials for patients with prostate cancer.
* Ensure high quality protocol development aligned with the overall Clinical Development Plan for assets 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 prostate cancer patient population.
* Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
* Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee review of data packages intended for internal and/or external IDMCs.
* 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 data during dose escalation and expansion studies and subsequent 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.
Why You?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Medical degree from accredited medical school
* Completion of a clinical residency program
* Experience in clinical research and development in Oncology
* Experience working in the pharmaceutical/biotechnology industry in GU prostate cancer.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Oncology experience in pharmaceutical/biotechnology industry preferred
* Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
* Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
* Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles
• 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 $222,750 to $371,250.
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.The annual base salary in Poland for new hires in this position ranges from PLN 455,250 to PLN 758,750 gross, taking into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer's discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.
More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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.
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