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General Description:
As a member of the organization, the Scientific Advisor will support regional strategies and establish compliant relationships with opinion leaders, research collaborators and key organizations in support of the client’s pipeline development across all therapeutic areas in the region of South-East Germany (including Traunstein, München, Augsburg, Ingolstadt, Nürnberg, Regensburg, Passau, Würzburg). This position will require pre- launch and post-launch Medical Affairs support for hematology and oncology pipeline development, focusing on malignant hematology. The incumbent will work closely with internal colleagues in medical affairs, clinical development, program leadership, clinical operations, legal, compliance, new product planning, safety/ pharmacovigilance, molecular diagnostics, translational research and other cross- functional business partners. The Scientific Advisor will support pre-clinical and clinical pipeline development by coordinating external collaborations, research endeavors with heath care providers and external academicians. He/She will play a key role in the establishment as a valued collaborator and best-in-class biopharmaceutical company.
This position reports to the Associate Medical Director, who in turn reports to the Country Medical Director.
Responsibilities:
• Provide education to the medical community on the client’s products and disease areas of focus.
• Work closely with internal stakeholders to develop and execute a medical plan designed to meet shared objectives.
• Facilitate responses to unsolicited requests for medical information, often in direct collaboration with the client’s Medical Information Services personnel.
• Develop tactics for communicating complex scientific information to the healthcare community.
• Provide impactful feedback/information to internal stakeholders on emerging clinical and scientific trends from external interactions to help shape company research, and to ensure the safe and appropriate use of products.
• Build specific excellence and integrity within the healthcare community. Develop contacts with key clinicians, university teaching hospitals, group purchase organizations and other medical / scientific groups.
• Develop speakers through one-on-one clinical training on approved clinical slide sets.
• Act as a clinical resource with professional and advocacy organizations with the objective of developing relationships and identifying potential business opportunities.
• Assist in the development and execution of clinically relevant regional medical meetings (e.g. advisory boards, consultancy and investigator meetings), as requested
• Identification and verification of investigators and sites for company-sponsored clinical trials
• Serve as the primary territory liaison for the submission and review of Investigator- Research proposals, facilitating the process from concept submission through publication and uncover scientific data that may have the potential for publication and/or abstract presentation.
Experience:
• Preferred existing experience as MSL or similar role within other biotech/pharmaceutical companies.
• Experience in hematology/oncology strongly preferred; candidates with experience in other related therapeutic areas (i.e. immunology) may be considered if they demonstrate clear potential to apply their existing skills to oncology.
• Clinical research experience is preferred.
• Knowledge of applicable treatment, compliance, and regulatory guidelines
• High level of English communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills. Capabilities and Competencies:
• Good verbal and written communication skills.
• Ability to effectively collaborate in a dynamic and global environment.
• Strong comprehension of disease states, and knowledge of differential algorithms for treatment decisions and experience in disease states of interest to the client.
• An expert understanding of the pharmaceutical industry, the country health care system, regional cancer care models and the impact on patient care
• Able to lead training initiatives and best practices.
• Strong time management and organizational skills. Education Required:
• MD, PharmD., or PhD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) preferred. At least 5 years’ experience in the therapeutic area of hematology/oncology.
• Location: Remote, South-East Germany.
• Travel: Work related travel required.
• PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint, Veeva).
Education Required:
• MD, PharmD., or PhD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) preferred. At least 5 years’ experience in the therapeutic area of hematology/oncology.
Ivory Systems
Project Manager, Contractor
This role is 100% Onsite in Devens, MA
Work Schedule is Mon – Fri, Business Hours
The Devens Biologics Manufacturing Project Management Office (PMO) Project Manager will manage and/or support the aspects of initiating, planning, and executing complex, multi-disciplinary projects throughout the projects’ lifecycle. With a breadth of hands-on project management experience in the Pharma/Biotech regulated environments, the Project Manager (PM) is expected to manage critical Biologics PMO projects in support of specific site and product programs. The PM will work with for the Devens Biologics Associate Director of PMO & Business Operations and with the PMO and the Operational Excellence (OpEx) team members to ensure alignment and coordination across site priorities. The PM will be responsible for using Devens PMO best practices, tools & templates and will be proficient in PMI project management standards, processes, procedures, and guidelines. The successful candidate must have a proven record of extensive professional experience and the drive to steer internal partners to efficient delivery of the projects on time & within budget.
Primary Responsibilities:
• Apply project management expertise across the portfolio for both standard and complex projects, managing multiple projects in parallel.
• Define project scope / goals / deliverables / budget / timeline
• Develops Work Breakdown Structures (WBS) and project plans with project team & Project Lead. Manages WBS in a Project Portfolio Management system (iPlan) and/or MS-Project. Sequences WBS activities, facilities discussion with project team to estimate activity resources and durations.
• Facilitates resource planning for project teams throughout the lifecycle of a project.
• Create project plans and manage dependencies, milestones, and deliverables
• Manages project schedules, including reconciling completed/not completed activities and proactively communicates upcoming activities to project team members.
• Aligns with Project Lead and Sponsor to take action(s) to drive performance of cross-functional teams. Appropriately escalates concerns to Project Lead or recommend escalation to project Sponsor.
• Partners with Project Lead to ensure successful delivery of projects. Schedules meetings for project team,
prepares meeting materials with/for lead as requested, facilitates team meetings as needed, and documents actions & decisions during project team meetings.
• Identify, handle, and resolve project-related issues and risks by developing specific action / risk mitigation / contingency plans and escalating early to Associate Director of PMO & Business Operations when necessary
• Prepare and present the business cases and communicate status for the assigned projects to the Leadership Team and/or Steering Committee(s). Clearly and concisely frames discussion topics to senior leaders to drive decisions
• Monitor execution and quality to customer / stakeholder / sponsor standards
• Independently leads large cross-functional project(s).
• Evaluate and assess the project outcome
Competencies & Experiences:
• 4 – 7 years of experience project management in a GxP environment
• 4 – 7 years of experience in Biologics / Pharmaceuticals with strong knowledge of biopharma industry
• Understanding of GMP and FDA regulatory requirements correlating to biologics
• Advanced degree in Life Sciences or technical field
• Project Management Professional (PMP) certification preferred
• Proficiency with related software tools such as: iPlan, MS Project, OneNote, MS PPT, MS Excel, etc.
• Experience with SharePoint, Smart Sheets, ServiceNow, etc.
• Solid analytical skills, problem solving and financial acumen
• Exceptional communication skills including ability to take an independent stance when interfacing with cross-functional stakeholders.
• Demonstrated focus on being able to translate data and metrics into predictable, value-add business insight
• Comfortable with uncertainty and meeting tight deadlines in the matrix environment.
• Demonstrated high degree of independence, requiring minimal supervision from senior management.
• Highly motivated, highly organized, passionate self-starter: detail-oriented and operationally focused
Physical Demands:
• This position is an office-based position that may require entry into laboratory/manufacturing spaces that requires appropriate levels of personal protective equipment (PPE).
• Office-based work requires sitting and repetitive use of arms/hands/wrists, especially when working with a computer.
Ivory Systems