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Create the future we believe in
Location: London, UK
Job Category: Clinical & Operations
Employment Duration :Full time
Responsibilities:
Manifest is seeking an oncologist with expertise in one of our key therapeutic areas – dermatology. The Assistant/Associate, Oncologist will:
Develop and implement clinical programs for oncology 505 (b)(1) and 505 (b)(2) products (ability to work in other therapeutic areas a plus).
Represent Manifest at US and international regulatory authority meetings
Design, conduct, analyze and report clinical trials, including protocol development, evaluation of safety information, data analysis and interpretation as well as report writing
Serve as company oncology expert, providing advice for both drugs/ideas in development and approved drugs
Organize and lead expert advisory boards, data safety monitoring boards and other meetings with external experts
Work with commercial colleagues to provide medical perspective/knowledge
Work with health outcomes/reimbursement colleagues to provide medical perspective/knowledge
Requirements:
MD or MD/Phd
Board certification in medical oncology (preferred) or related subspecialty
Passion to bring therapies to cancer patients, ability to focus on critical tasks, and creativity to solve unique problems not previously encountered by prior scientists
1-3 years’ experience with clinical trials, may consist of enrolling patients a primary caregiver on clinical trials
1-3 years’ experience caring for oncology patients, including administration of chemotherapy as primary caregiver
1-2 semesters coursework in biomedical statistics
Relevant coursework and/or laboratory experience, which can include experiences with laboratory benchwork
Location Budapest, Romania
Job Category: Clinical & Operations
Employment Duration: Full time
The Associate Vice President, Biostatistics and Data Management, is responsible for applying, managing, and overseeing all aspects of clinical statistics, programming, and data management, including managing statistics/programming/DM tasks and budget, interfacing with in-house staff/senior management and in maintaining global data/analysis standards, regulatory compliance and department procedures.
Responsibilities:
Responsible for all aspects of data management, programming, and statistical planning, methodology, and analysis or oversight of such tasks performed by an external vendor: Perform clinical database build with all related processes, design database and dataset structure, create Data Management Plan, Data Quality Plan, Data Review Guidelines and edit specifications; Provide input into clinical study protocol and create/review/approve statistical analysis plan (SAP) and its implementation.
Interface with in-house staff: Participate on Senior Management Team and Project Teams; Review monitoring guidelines and Clinical Study Reports; Work closely with Medical Monitor(s) and KOLs to design statistically sound and viable clinical trials, participate in Clinical Department Review Committee, lead global heads of statistics, data management, and programming.
Work with internal staff or vendors to assure that all data management, programming and statistical analyses are properly conducted and validated to allow for proper analysis and interpretation required for inclusion into reports and regulatory submissions.
Responsible for the identification, creation and maintenance of department procedures: Participate in departmental initiatives related to process building and improvement.
Work within SUN, as necessary, to implement global data management/programming/statistical analysis procedures, processes and standards.
Work with senior leadership on strategic planning, external collaborations, due diligence activities, organizational changes, and business development.
Requirements:
Performed as a clinical statistician for multiple clinical trials with submission experience and interaction with regulatory authorities
Experience with various clinical databases, specifically EDC systems
Experience exhibiting SAS programming skills and ability to apply these to statistical analyses and novel applications of statistics
Familiar with CDISC and AdAM standards, compiling data packages for submissions
Experience with power and sample size calculations and a wide variety of study designs for Phase 1-3 programs
Ph.D. in statistics a plus with 10+ years of related experience or M.S. in statistics with 15+ years of related experience
Excellent Mathematical Skills and Problem Solving Skills
Expert in SAS programming with demonstrated experience using Base SAS, SAS Stat, many Statistical Analysis procedures, Reporting and Graphical Procedures, Macro, SAS Version 9.2 or higher in a clinical trials setting BackEmail
Location: Dublin, Ireland
Job Category: Research
Employment Duration: Full time
Responsibilities:
Responsible for achieving coverage and frequency targets, and consistently achieving sales targets in assigned territory.
Contributes to regional training, developing the key skills of other team members.
With guidance, initiates systems to monitor sales progress and action plans. Regularly measures success, documents and provides feedback on performance.
May work in collaboration with outside partner companies to co-promote products or services.
Manages territory budgets for customer contacts, speaker events and other miscellaneous external expenditures.
May represent company at professional events and promote company products at such events.
Works cooperatively with Medical Science Liaisons, National Account Managers, Marketing and other internal Manifest team members on various cross-functional projects.
Assists in the identification and resolution of issues and opportunities, and communicates proactively to marketing and sales management.
Completes necessary administrative tasks in a timely manner e.g. updating customer database, expenses.
Communicates and functions across the commercial team, ensuring efficient collaboration on projects.
Operates in compliance with Manifest commercial compliance policy, and all applicable federal and state laws and guidance relating to product promotion and information dissemination including, but not limited to, the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration’s implementing regulations, the Federal Anti-Kickback Statute, the False Claims Act, PhRMA, Corporate Code of Business Conduct and the Office of the Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers.
International Theapeutic Specialist
Responsible for achieving coverage and frequency targets and consistently achieving sales targets in assigned territory. Represents Manifest’s products and services to a defined customer base within a specific geographic area. Utilizes a level of product and therapeutic disease working knowledge to promote the appropriate use of Manifest products to healthcare professionals. Prepares business plan for own territory, assigns targets and communicates required actions to achieve goals. With guidance, initiates systems to monitor sales progress and action plans. Prepares territory budgets for customer contacts, speaker events and other miscellaneous external expenditures. May work in collaboration with outside partner companies to co-promote products or services. May represent company at professional events and promote company products at such events. Works cooperatively with Medical Science Liaisons, National Account Managers, Marketing and other internal Manifest team members on various cross-functional projects related to specific accounts or physicians. Works as an individual contributor. Builds and extends business relationships with key customers or accounts. Assists in the identification and resolution of issues and opportunities, and communicates proactively to marketing and sales management. Completes necessary administrative tasks in a timely manner e.g. updating customer database, expenses, etc. Responsible for achieving the competency levels required in the role. Compliance with all regulatory agencies, state, and federal law is required.
International Therapeutic Specialist
Responsible for achieving coverage and frequency targets and consistently achieving sales targets in assigned territory. Represents Manifest’s products and services to a defined customer base within a specific geographic area. Utilizes a level of product and therapeutic disease working knowledge to promote the appropriate use of Manifest products to healthcare professionals. Prepares business plan for own territory, assigns targets and communicates required actions to achieve goals. With guidance, initiates systems to monitor sales progress and action plans. Prepares territory budgets for customer contacts, speaker events and other miscellaneous external expenditures. May work in collaboration with outside partner companies to co-promote products or services. May represent company at professional events and promote company products at such events. Works cooperatively with Medical Science Liaisons, National Account Managers, Marketing and other internal Manifest team members on various cross-functional projects related to specific accounts or physicians. Works as an individual contributor. Builds and extends business relationships with key customers or accounts. Assists in the identification and resolution of issues and opportunities, and communicates proactively to marketing and sales management. Completes necessary administrative tasks in a timely manner e.g. updating customer database, expenses, etc. Responsible for achieving the competency levels required in the role. Compliance with all regulatory agencies, state, and federal law is required.
