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A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
• Serves as a single point of accountability to the company Essential Health (PEH) business unit (BU) for clinical deliverables involving anti-infective products. Focused on the design, execution, monitoring, delivery, and reporting of one or more clinical studies.
• Ensures appropriate medical and scientific expertise is brought to the clinical trial design, execution and interpretation of data, study reports, and clinical safety.
• Performs clinical trial safety review in role of Physician-Clinician (medical monitor).
• Assures that clinical trial objectives fit with the clinical program strategy.
Clinical Development- including but not limited to:
• Point of accountability for selected anti-infective products within Clinical Affairs
• Point of accountability to the Business Unit for design, execution, monitoring, delivery and reporting of one or more clinical studies (or elements of those studies).
• Provides medical and scientific expertise to the clinical trial strategy and development process, including acquisition of knowledge of competitor products.
• Ensures the most efficient clinical protocols are developed through the application of enhanced trial design.
• Designs/writes clinical trial outlines, in collaboration with internal contributors (e.g. statisticians, OR specialists, clinical pharmacologists, clinical project managers, market access colleagues, commercial development colleagues), internal experts (e.g. clinical disease area expert), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.
• Provides medical input to protocol/study team for monitoring guidelines, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team).
• Contributes to CRO/vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).
• Oversees study management staff in identification, evaluation and selection of countries and clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.
• Creates (and where appropriate, delivers) medical/protocol training materials for study and site management and for use during study initiation visits and investigator meetings.
• Helps establish and oversees Data Monitoring Committees (DMCs) and adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcome.
• Contributes to (and may oversee) clinical trial safety by performing safety review and analysis of pre-market and/or post-market trials and tracking emerging efficacy and safety profile of drugs consistent with Safety Review Plan; responsible for identifying emerging safety trends and raising them forward for further discussion with the Clinical sub-team and/or medical development team.
• Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
• Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
• Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions in regulatory based results database such as CT.Gov
• Assists in ensuring regulatory compliance for clinical trials and reporting.
• May act as primary contact with external investigators and internal study team for questions relating to the scientific/medical aspects of the protocol.
• Responsible for keeping Clinical Sub-team and or Medical development team informed of any critical issues relating to benefit:risk evaluation.
• Presents to internal and external advisory committees (e.g. TRC, advisory boards) on design of clinical trials and data from clinical trials.
• Assists in discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.
• Leads or assists in the preparation of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).
• Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.
• Leads or assists in the development of publications, abstracts, presentations.
• May support technical review of licensing opportunities, including due diligence activities.
As a Clinical Lead
• Accountable for design and final recommendations for clinical plans for compounds / indications overseen by their respective Development Team, post POC to LOE.
• Accountable for negotiating milestones and ensuring execution and delivery of the clinical plan in line with agreed timelines.
• Leads the Clinical Team to design, execute and interpret post proof of concept (POC) studies.
• Acquires knowledge of competitor products and clinical plans, and maintains and enhances knowledge in relevant therapeutic or technical areas.
• Plans resources required both within Clinical Affairs and in conjunction with other relevant lines to accomplish the clinical objectives in a timely and resource-efficient fashion, including consideration of FTEs and operational resourcing.
• Ensures development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinical lead may delegate these responsibilities to the study clinician identified in the SRP. For all studies, clinical safety review should be performed in consultation with a designated medical monitor if neither clinical lead nor clinician are medically qualified.
As a Physician Clinician
• In addition to above duties, medically qualified clinicians may assume the role of physician clinician in oversight of non-medically qualified clinicians. Specific duties that require medical oversight include IB review, protocol review, safety review and clinical study report review. In addition, a physician clinician must be available for medical questions from investigators when required.
• Consistent with SRP, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead (as delegated by the clinical lead). The specific components of safety data review are detailed in the Safety Data Review Guide.
• Motivates and engages colleagues to facilitate an understanding of disease and foster team commitment to support an indication and mechanism.
• Coaches and mentors less experienced clinicians.
• Maintains and enhances knowledge in relevant disease area and/or technical area and practice guidelines relevant to the regions in which clinical trials are being conducted.
• Facilitates sharing of information on technical or operational best practices and lessons learned across Clinical Affairs.
• MD, DO or equivalent (preferred). Demonstrated clinical/medical, administrative, and organizational and project management capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the company.
• Postgraduate training/certification /fellowship in a specified medical discipline or in drug development.
• Demonstrated scientific productivity (e .g. doctoral thesis, publications, research reports, etc).
• Thorough understanding of local and international regulations applicable to clinical development.
• Track record of design, oversight and interpretation of clinical studies.
• Previous leadership/management experience or training (preferred).
• Required: 5-8 years expertise in Phase 2-4 clinical development in the pharmaceutical industry, practical experience in clinical trial strategies, methods and processes.
• Preferred: Anti-infectives experience in Phase 2-4 clinical trials
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Ability to travel 20% (international and domestic).
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
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