Drug Development Project Management
Classification: contract position, 20-30 hours/week.
we require an experienced project manager (pm) to be responsible for overall project management of a biologic in preparation for filing of us ind as well as ex-us clinical trial applications. The pm will work with a number of expert consultants contracted to us and external service providers as integral parts of the drug development team.
Duties will include managing all operational aspects of the project including development and management of overall project timelines, meeting management (scheduling, agendas, minutes, action items follow-up), logistics support, contract and proposal development, document review cycles, coordination of multiple cmo schedules and activities. The pm will be accountable to the vp of operations.
The company headquarters is located in austin, texas; however, the position can be located in austin (no relocation benefit) or virtual. The pm must generally be available during working hours that support us time zones.
Essential duties and responsibilities:
-facilitate and provide hands-on support ensuring seamless handoffs and coordination among key functional areas
-prepare timely agendas and minutes for project team meetings and ensure completion of action items
-develop and maintain high level and detailed timelines of the project plan and through use of project management software tools, ensure that the functional resources and timelines are aligned with global project timelines
-provide support in resolving project issues by managing contingency planning and influencing risk mitigation strategies with input from the team
-actively communicate any discrepancies in project timeline, costs or quality to the vp operations; -anticipate and participate in the resolution of budget issues, timeline delays and/or competing priorities
-prepare project progress reports, identifying and anticipating issues that threaten a project’s adherence to the timeline and budget
-track functional area milestones (cmc, nonclinical, clinical, and regulatory) and sub-team activities to ensure overall adherence to the project plan and timeline
-support diligence by and management efforts of external auditors, investors and alliance partners as needed.
Education and experience:
-bachelor’s degree (life science degree preferred) and 3 – 5 years’ experience in project management in the biotech or pharmaceutical industry, preferably in a setting that includes management of multiple external vendors
preferred: advanced degree(s) (ms/ph.D. In life science, mba, pharmaceutics) and project management certification
knowledge of project planning software (e.G. Ms project, conceptdraw project/mindmap)
please attach your cv/resume here.+60 Other Responses
Chief Medical Officer
We're looking for a chief medical officer:
this position serves as a clinical and medical leader of the company and is responsible for developing and implementing the overall medical and clinical strategy that advocates for our patients overall health and well-being while delivering innovative products and technologies. the desired candidate will be skilled in clinical program design and execution in the context of a development organization. Experience and knowledge in interactions with clinical investigators, collaboration with regulatory affairs, and fda interactions is required.
Essential duties and responsibilities include the following. Other duties may be
accountable for the entire clinical development process
conceive and execute clinical strategy for all technology platforms
build, develop, and lead a motivated and engaged matrix team who are responsible for the day-to-day design and execution of clinical programs
lead preparation of clinical sections of all relevant regulatory filings (ide, pma, ind, clinical study reports, nda/bla, etc)
design and oversee protocols for all phases of a clinical program
advise on first in human decision point and endorse first dosing in humans
serve as an expert on clinical and medical issues
review study data, including safety monitoring, sae reporting, and analysis/tracking of emerging efficacy profile
write final study reports and prepare of documents for regulatory submission
interact with the broader invivo organization to share expertise
interact with key opinion leaders to ensure implementation of latest clinical thinking and guidelines into clinical development plans, as well as consideration of novel clinical methods
serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
manage strategic relationships with key partners
assist in the development of publications, abstracts, and presentations
represent the company at scientific meetings and presentations, interact with foundations, as well as other public relations opportunities
support business development activities as needed, including due diligence human resources:job descriptions:chief medical officer job description.Docx 7/16/2015
serve on leadership team of and provide clinical development insight to investment decisions
md or equivalent medical qualification
deep understanding of the biotechnology environment and the drug/device development process
demonstrated knowledge of designing, executing and delivering clinical programs to produce both timely and good quality data including knowledge of innovative clinical trial principles and methodologies
strong focus on finding innovative ways to leverage external expertise and funding, taking risk, focusing on new methods, exploring adjacent scientific
strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization, including senior management.+11 Other Responses