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Category: Biotechnology/Pharmaceutical
Title: Sr. Director Global Clinical Operations
Description: Leads and drives all operational and administrative functions in therapeutic area clinical programs by ensuring the execution of clinical studies to successfully register new products/indications. Exercises a high degree of quality, productivity and communication to the department and therapeutic area for the timely completion of all clinical studies. Hires, develops and motivates staff to ensure scientifically valid studies conducted according to Good Clinical Practices. Leads assigned clinical sub-teams to rapidly deliver studies, which meet minimum and desired requirements in an efficient manner using high quality scientific rationale. Provides project and resource management across therapeutic area portfolio. Serve as a member of therapeutic area management team with focus on project and resource management for clinical projects and participates in therapeutic area teams to provide input to ensure studies are executable. Contributes to Global Development Operations strategic and operational development by active participation in the GDO executive leadership team. The employee must conduct their work activities in compliance with The Company's internal requirements and with all applicable regulatory requirements. The Company's internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. KEY INTERFACES: Routine contacts with Development Operations, Global Project Team; Legal; Project Management; Medical Affairs; Biostatistics, Data Management and Programming; PSO; PK; Toxicology; Global Regulatory Compliance; The Company's Therapeutic Areas; Regulatory Affairs; Corporate Communications. External interfaces include: various contract research organizations and other vendors for clinical services, therapeutic consultants. KEY DUTIES AND RESPONSIBILITIES: % of Time 1. Global Clinical Operations: Works collaboratively with other Development Operations Leads to agree upon processes, systems and procedures to lead Global Development Operations. Direct and leads the operations for multiple global therapeutic area clinical programs which includes implementation study protocol ensuring patient enrollment has met study goals. Provides feedback to TA on operational aspects of protocol design. Acts as a resource for operational process improvement ideas and targets. Serves as content expert in execution of clinical operations. Provides guidance in development and modification of clinical timelines and resource requirements. Ensures appropriate number of staff with appropriate skills, knowledge and experience are assigned to study. Ensures proper metrics and diagnostics are utilized to ensure staffing levels meet study requirements and also reallocates staff to priority projects within Global Development Operations. Works collaboratively with Therapeutic Areas to ensure study design and critical study decisions are made collaboratively to ensure study success. Performs other duties as assigned. 30% 2. Clinical Study Management: Ensures operations team, globally, follow any and all SOP's, policies and regulatory requirements. Also works in tandem with other Global Development Operations Leads to ensure consistent processes are collectively agreed upon and followed by all Global Development Operations team members. Ensures timely communication and problem resolution occurs when study progress may not be meeting study goals. Ensures documentation and reporting occur in a timely manner. Ensures appropriate global tracking and management of study is occurring. Provides operations services to Clinical Leads and Project Team Leaders. Operationally leads clinical research teams to rapidly deliver operational excellence for new projects or indications that meet minimum and desired characteristics for worldwide registration. Ensures all regulatory requirements are adhered to when applicable. Proactively plans study prioritization, budgetary requirements and goal attainment. Ensures consistency with processes and procedures. 30% 3. Leadership and People Development: Provides leadership and direction to operations teams in Irvine and globally. Properly analyzes staffing needs to ensure studies are staffed accordingly. Also ensures staff are coached and developed for optimal performance and are current with new SOPs, policies, processes and regulatory requirements. Provides timely feedback.
Qualification: MINIMUM REQUIREMENTS Education and Experience " Bachelors degree with experience in a relevant field: BS degree with 15 years experience, MS degree with 12 years experience " An MBA or MPH is highly desirable. " Therapeutic Area experience strongly preferred " Minimum 15 years experience working in a clinical operations organization, preferably within pharma or CRO. " Minimum of 15 years experience working in clinical research with a strong understanding of the clinical and drug development process " Minimum 8 years leading and managing highly diverse and educated teams " Thorough understanding and knowledge of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas. " SAP experience a plus " Ability to travel up to 40% Essential Skills and Abilities Competencies/ Essential Skills Proficiency " Ability to influence others without direct reporting relationships " Ability to make good business decisions that may be unpopular " Strong networking skills both internally and externally " Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences " A self starter " Ability to multi-task and prioritize " Excellent planning, organizational, and project management skills " Strong financial business acumen and analytical skills " Strong negotiation skills " Strong conflict management skills " Strong interpersonal skills to be successful working in highly matrixed organizations " Cross-cultural sensitivity " Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality " Strong team leadership skills and motivational skills " Ability to meet challenging milestones " Ability to problem solve independently and with others " Advanced computer skills (word processing, spreadsheets, graphics, Powerpoint).
Contact: dougf@nsasearch.com
Category: Biotechnology/Pharmaceutical
Title: Sr Director Global Regulatory Opertions
Description: Our client is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs - and into the priorities and concerns of the medical specialists who treat them. This position is responsible for directing multiple functional organizations within Regulatory and Operations. This includes Global Regulatory Support, Publishing, Business Development, Regulatory Intelligence and Information Management in support of the organization's global product portfolio. This position also independently develops, implements, maintains and manages the strategy for areas of responsibility in alignment with the global Regulatory strategy. Accountable for managing the relationships and communications with Regulatory Authorities, other Functions, and External Business Partners as necessary for the various functional areas within Global Regulatory Operations. Summary: " Guide, direct, and lead a team of regulatory professionals in development and implementation of strategy for areas of responsibility. Identify risk areas and develop alternative courses of action through scenario planning and development of contingency plans. " Lead the creation and maintenance of the global submission strategy " Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with relevant agencies, industry organizations, and external business units and functions. " Develop and manage regulatory operations budget " Accountable for ensuring that relevant regulatory submissions meet appropriate standards including planning and implementation around emerging/changing regulatory requirements. " Prioritize all business development initiatives and communicate regulatory assessments. Provide Regulatory Intel support for development projects. Additional dimensions of the role: " Global responsibility for regulatory submissions " Responsible for support of Global registrations " Responsible for regulatory Intel in support of development projects
Qualification: Education and Experience " Advanced science degree or country equivalent in pharmacy or related-scientific field of study with minimum of 10 years pharma regulatory or equivalent experience. Essential Skills and Abilities " Excellent written and verbal communication, presentation, negotiation and facilitation skills " Expert knowledge of regulations and application/maintenance process within multiple regions, and strong experience with interpretation and application " Proven analytical skills with the ability to evaluate needs and develop and implement effective solutions independently " Knowledge, experience with use of relevant industry available software and hardware (e.g., scanners, printers, MS Office, Documentum, CoreDossier, and, ISI Toolbox). " Risk identification and problem solving skills " Demonstrated ability to lead, mentor, and develop others " Established relationships with regulatory authorities " Extensive familiarity with Industry and knowledge of regulatory requirements impacting function " Ability to travel
Contact: dougf@nsasearch.com
Category: Biotechnology/Pharmaceutical
Title: Global Safety Officer
Description: The Global Safety Officer (GSO) participates in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development. Activities of the GSO include medical analysis and decision making for the development and maintenance of the Company Core Safety Information, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities and reports, risk management plans (RMPs/REMS), individual case safety reports (ICSRs), and field alert reports. Supported by the Global Safety Scientists, each GSO works in cross-functional teams with counterparts in regulatory labeling, clinical development, pre-clinical, manufacturing/quality, epidemiology, and other functional areas to identify, evaluate, and communicate safety issues relevant to her/his assigned products. Key Duties and Responsibilities: " Company Core Safety Information " Ad hoc aggregate reports " PSURs " Signal detection and evaluation " Safety specification of RMPs, REMS " Individual Case Safety Reports " Other activities, ongoing training
Qualification: Education and Experience: " M.D. or equivalent (D.O., M.B.B.S, etc.) " At least 1-2 years of experience in pharmacovigilance and risk management, with experience in preparing and analyzing aggregate reports, risk management plans, and company core data sheets highly desirable. " Board certification preferred, however a variety of clinical experiences are well-suited for this position. " Working knowledge of global pharmaceutical regulations and guidances highly desirable. Essential Skills and Abilities: " Clinical experience and sound medical judgment " Excellent analytical skills and the ability to both write and review medical reports " Excellent written and oral communication skills " Excellent computer skills; knowledge of ARGUS and Business Objects a plus " Excellent interpersonal, organizational, and team-building skills " Flexibility and ability to adapt and learn quickly
Contact: dougf@nsasearch.com
Category: Biotechnology/Pharmaceutical
Title: Director/Sr. Director Clinical Opertions
Description: Director/Sr Director Clinical Operations Location: San Diego, CA Job Summary This role will be responsible for overall clinical program management of phase 0-III studies. The successful candidate will manage CROs, clinical sites, liaise with Finance and Project Management and be responsible for coordinating the clinical study reports and clinical sections of the IB, IND/CTAs and NDAs/MAAs. Primary Duties and Responsibilities " Participate as an integral team member in CRO selection, and provide primary oversight for RFPs, contract management and CRO management. " Track and report clinical information regarding patient recruitment and screening, monitor visit schedules and coordinate other clinical study needs. " Interact with active and potential clinical investigators. " Conduct study monitoring visits and co-monitoring visits with CROs (as needed until a CRA is hired.) " Organize meetings and teleconferences for clinical and safety issues. " Work with CROs and/or clinical sites to design/review informed consent documents, CRFs, protocols, SAE reports and other study documentation. " Organize and run meetings and teleconferences for clinical and safety issues for clinical studies. " Coordinate clinical project timelines with Project Management to meet critical milestones; and/or escalate issues that may jeopardize timelines and deliverables. " Liaise with other functional areas, such as Preclinical Development, Pharmaceutical Sciences and Regulatory Affairs in order to accurately coordinate clinical study activity. " Coordinate the writing of clinical study reports and clinical sections of the Investigators Brochure, INDs/CTAs and NDAs/MAAs. " Work with Finance to develop budgets and cost estimates and track the financial status against budget. " Maintain up-to-date knowledge of clinical principles and theories of drug development and study design in the organization's therapeutic areas. " Maintain clinical study files per ICH guidance. " Manage Clinical Program Managers. " Other duties as may be necessary.
Qualification: Preferred Requirements " Bachelors Degree with a science major preferred. " 8+ years of clinical operations and overall drug development in the pharmaceutical/biotechnology industry. " At least 5+ years of intimate knowledge of the oncology and/or anti-viral therapeutic area. Strong experience in management of CROs. " Demonstrated skills in protocol, CRF and the development of study documentation. " Knowledge of FDA regulations and ICH guidelines regarding GCPs. Phase 0-3 clinical trial experience. " Demonstrated experience in writing the clinical sections of an IB, IND and/or NDA. Proficiency in strategizing, planning, monitoring and problem solving. " Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly. " Ability to manage multiple and diverse issues. " Strong facilitation, organizational, analytical and time management skills. " Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project. " Ability to apply knowledge to new situations. " Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement. " Ability to "roll up your sleeves" and individually contribute results to a research and development effort. " Experience writing technical and management documents, reports and presentations. " Some travel is to be expected, 20%.
Contact: dougf@nsasearch.com
Category: Biotechnology/Pharmaceutical
Title: Pathologist
Description: Seeking two experienced MD or MD, PhD Pathologists who are Board certified (AP or AP/CP) with licensure in the New York/Tri-State region. Subspecialty/expertise in uropathology, breast pathology and cytology is desirable. The ideal candidates are accomplished, mid-career anatomic pathologists with particular interest in enhancing morphologic observations with methods to further extract information from paraffin sections (e.g., morphometry, biomarker localization), and who would be attracted by the challenge and potential of the integrated analytical approach of Systems Pathology. While both successful candidates shall be expected to interact regularly with the scientists in the Molecular and Biomarker Technologies, as well as the mathematicians and biostatisticians in the Machine Vision and Machine Learning divisions, one (the service Pathologist) shall be primarily concerned with the evaluation, processing and reporting of specimens for our commercial predictive prostate cancer tests; the other shall be primarily involved in research and development. The Service Pathologist shall be responsible for the accurate and timely evaluation of surgical specimens, for generating and evaluating pathological, morphometric and biomarker data for patients or assigned studies, through direct/indirect supervision of individuals assigned to studies. In addition he/she will oversee QC/QA programs to insure compliance with CAP, DOH and other accreditation programs. The R&D Pathologist is expected to participate in the evaluation and implementation of new techniques and approaches to molecular oncology and/or of new procedures. A current knowledge of recent advances and new equipment/procedures (e.g., immunohistochemistry, immunofluorescence, image analysis, in situ hybridization, laser capture microscopy, quantum dots, quantitative PCR, multiplex assays, etc.) is expected. He/she will participate in the design and implementation of complex projects requiring the most advanced interpretive experience and knowledge.
Qualification: MD degree with Pathology Board certification and experience in molecular pathology. GU experience is desirable Ability to work on multiple projects and under strict deadlines Ability to work in a team environment Excellent oral/written/presentation communication skills Demonstrated ability to communicate effectively with others.
Contact: dougf@nsasearch.com
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