GSK is seeking a Senior Medical Director, Oncology Clinical Development - GU, to lead clinical research activities and advance their clinical portfolio. This role involves developing and executing oncology clinical trials, managing relationships with Key External Experts, and engaging in medical dialogues with internal scientific and medical leaders. The position requires an experienced professional to support the successful clinical development, regulatory filing, and market launch of innovative Oncology agents.

Practice Info

• On-site office presence (minimum of two days a week) at one of GSK's Switzerland (Zug), Poland (Warsaw), UK (Stevenage or London HQ) or US (PA or MA) sites.

• Lead Oncology Clinical Development-wide initiatives and workstreams as appropriate.

Responsibilities

• Exhibit leadership at the program and cross-functional level and 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

• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.

• Oversee the development of high-quality protocols 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.

Compensation

• 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 $284,250 to $473,750.

• 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.

• The annual base salary in Poland for new hires in this position ranges from PLN $593,250 to PLN $988,750 gross.

• 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).

Benefits

• 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.

• 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.

Requirements

• Medical degree and completion of advanced specialty training, fellowship or country-equivalent higher-level qualification in Medical Oncology, Radiation Oncology, Urology or Internal Medicine (with GU or oncology experience).

• Experience in the global pharmaceutical/biotechnology industry in the field of GU prostate cancer.

• Experience leading GU Oncology drug development, including Phase 1, 2 and 3 clinical trial design, initiation, execution, and closure.

• Academic and/or clinical research publication history or history of medical practice in GU Oncology.

• Preferred: PhD in addition to medical degree and completion of advanced specialty training, fellowship or country-equivalent higher level qualification.

• Preferred: Established personal and professional relationships with key external experts (KEEs) in medical oncology and credibility within the medical community.

• Preferred: Experience in the clinical assessment of business development opportunities to expand a growing portfolio

• Preferred: Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.

• Preferred: Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

• Preferred: Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles.