Early Clinical Development Medical Director, Oncology

GSK Oncology Early Clinical Development is seeking a highly skilled and motivated Early Clinical Development Medical Director- Oncology to join our dynamic Oncology Research and Development this role the successful candidate will create a strong link between Clinical Development and Pre-clinical/ Discovery teams to improve forward and reverse translation and thereby increase the success of our Oncology clinical portfolio in the prostate cancer space. This role offers a unique opportunity to bridge the gap between preclinical research and clinical development ensuring the successful translation of innovative therapies from the lab to the clinic.

The Early Clinical Development Medical Director- Oncology will report to the Executive Medical Director Early Clinical Development Lead (ECDL)-GU Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSKs 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) 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 medicines 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 GSKs 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 developmentin Oncology

• Experience working in the pharmaceutical/biotechnology industry in 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

Why GSK

Our values and expectationsare 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
• Managing individual and team performance.
• Committed to delivering high quality results overcoming challenges focusing on what matters execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being building resilience in teams.
• Continuously looking for opportunities to learn build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative motivating others setting objectives and delegation.
• Building strong relationships and collaboration managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting commercial and financial acumen.

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 $222750 to $371250. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the 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 annual base salary in Poland for new hires in this position ranges from PLN 455250 to PLN 758750 gross taking into account a number of factors including the candidates 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 employers 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 were 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your inquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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