Medical Director, Study Responsible Physician - Prostate

Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – MD Job Category: Scientific/Technology All Job Posting Locations: Spring House, Pennsylvania, United States of America 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Director Clinical Research Oncology is a member of a matrix team dedicated to the implementation of clinical research studies that are part of a global compound development program. The Director supports the Clinical Leader and provides active scientific contributions to a cross-functional clinical team developing a compound currently being studied for new oncology applications. He/She provides mentoring and support to the clinical study team and works closely with the clinical project scientists and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology. Together with the Clinical Leader, the Study Responsible Physician will represent the clinical team in governance and committee meetings relating to the overall strategy and operational implementation of the clinical studies in the development plan. The role requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards. The successful candidate must be equally comfortable among the team to which he/she is assigned and in the global environment in which the company operates. The Director Clinical Research Oncology holds overall responsibility for flawless execution of the assigned study/studies, leading the study team in a matrix organization. He/She assists in the preparation of protocol writing for and operational execution of clinical studies. He/She leads the medical review of critical data collected throughout the study. He/She participates in the interpretation and reporting of the results of the research, including submission to health authorities. He/She evaluates scientific information and new ideas to assist in identifying new research opportunities. The Director supports medical affairs activities involving product evaluation, labeling and surveillance. He/She will assess external clinical research proposals involving company products and manuscripts that are being prepared for publication. The Director acts as a liaison between the company and clinical investigators. The Director develops, in concert with senior clinical staff, credible relationships with opinion leaders, and clinical research staff globally. The Director Clinical Research, Oncology reports directly to a Clinical Leader for the product to which he/she is assigned. ESSENTIAL FUNCTIONS 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 The anticipated base pay range for this position is : $199,000.00 - $343,850.00 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)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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