Director, Clinical Research Oncology Location: Spring House, Pennsylvania, United States of America. Job Function: Discovery & Pre-Clinical/Clinical Development; Job Sub Function: Clinical Development & Research – MD; Job Category: Scientific/Technology. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Responsibilities Leads the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program. Works closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders. Provides support for clinical study/studies within a development program including: working closely with clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths. Working in partnership with clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies. Collaborating with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol‑required evaluations. Participating in strategic study start‑up planning in collaboration with GCO and C&G including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations. Co‑leading and overseeing clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents. Working closely with Medical Writing to support protocol or protocol amendment completion. Working closely with Clinical Leader, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion. Working closely with GCO to track study recruitment and implement action plans to address early impediments to study enrollment. Working closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans. Working closely with clinical scientists and data management to support medical review and data query resolution. Interacting with clinical investigators and Key Opinion Leaders as appropriate. Working with GCO to provide oversight of CRO/study vendors’ performance as it relates to study start‑up and conduct. Working with the Clinical Leader, with Data Management and with Statistics on analysis of study results and completion of study reports. Works with the Clinical Leader to support the development and compilation of NDA/MAAs and to support responses to Health Agency questions and HA presentations post‑filing. May review/co‑author medical publications emerging from clinical trial results. May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards. Qualifications This position requires a minimum of an Advanced Degree in Medicine (i.e. M.D or equivalent). A trained (Board certified or Board eligible) Uro‑Oncologist/Oncologist is strongly preferred. Applicable post‑doctoral fellowship training is required. A minimum of 3 or more years of experience in a relevant urology/oncology clinical research position is required. Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important. Strong oral, written communication and presentation skills is required. Successful work experience in a matrix team environment with cross functional teams is required. The ability to use influencing skills is required. Travel required may be up to 20‑30% annually (international, as well as domestic). Required Skills Business Savvy Clinical Research and Regulations Clinical Trials Collaborating Consulting Data Management and Informatics Design Mindset Drug Discovery Development Industry Analysis Innovation Market Research Regulatory Affairs Management Research Ethics Scientific Evaluation Scientific Research Stakeholder Management Strategic Analysis Preferred Skills Business Savvy Clinical Research and Regulations Clinical Trials Collaborating Consulting Data Management and Informatics Design Mindset Drug Discovery Development Industry Analysis Innovation Market Research Regulatory Affairs Management Research Ethics Scientific Evaluation Scientific Research Stakeholder Management Strategic Analysis Pay & Benefit The anticipated base pay range for this position is: $199,000.00 - $343,850.00. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52‑week rolling period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time‑Off – 80 hours per calendar year #J-18808-Ljbffr