Michael Keating Email & Phone Number

New York, New York, Us

Lead clinical execution of Phase 2 and 3 studies of medium-high complexity and significant business impact. Lead development of Protocols and Amendments. Author and Approve Informed Consent Documents (ICDs) including responses to external stakeholders Review and approve country selection, site selection criteria and ensure protocol specific training. Review safety data, SAE reports, TMEs, DMEs and ensure clinical documents are updated as required. Input and review of the CSR. 2023 Craig Saxton award winner for Excellence in Clinical Development.

Medical Monitor for 3 Global Phase III trials and 2 Phase II trials.Protocol and Amendment writing / review for all trials related to Ulcerative Colitis.Prepare, manage and review clinical study, regulatory and other safety documents as appropriate.Support preparation of abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, INDA sections).Participate in long range strategic planning for products in development.

Basel, Ch

Lead/Chair the US Phase 3B/IV Program for Uptravi (selexipag).Medical Monitor for US Phase IV trials for Uptravi (selexipag).Write protocols / amendments to support the Medical Strategy for Uptravi (selexipag)Responsible for the development and implementation of Uptravi (selexipag) medical plan.Manage and oversee Uptravi (selexipag) investigator initiated studies program (IIS).

New York, New York, Us

Develop a robust Opinion Leader Database and engage in Scientific Exchange with Healthcare Professionals on new treatments for Prostate Cancer.Present data to both internal and external stakeholders.Develop the Medical Affairs Strategy for the Oncology Franchise.Develop and implement educational initiatives for both Healthcare Professionals and Covis field sales force.

Boston, Massachusetts, Us

Working to develop the disease state awareness and serve as educational resource on ultra-rare disease states.Serve as a scientific/medical peer-to-peer resource for scientific aspects both internally and externally.Support clinical initiatives including site identification, trial recruitment and presentation of final approved data.Discuss and assess investigator-initiated research proposals. Serve as point-person and conduit for respective projects.Provide medical and scientific input into regional advisory boards, work with their physician experts to review speaker presentations and provide medical references where requested.

Basel, Ch

Provide field-based medical and scientific support for Actelion products and therapeutic areas with Opinion Leaders, Specialty Pharmacies and Internal Stakeholders.Provide support for researchers who are interested in conducting Investigator-Initiated Studies (IIS), or who are interested in participation in Actelion-sponsored clinical trials.Provide medical/scientific support for critical Actelion activities including speaker training, advisory boards, and sales training as appropriate.Responsible for the training of new hire MSLs.Serve as Medical Science lead for Ventavis (iloprost) and cadazolid.

Basel, Ch

Medical Science Liaison for Georgia, Florida and Puerto Rico.Responsible for the cultivation of collaborative relationships with current and future thought leaders in academic and clinical medicine.Work with all field sales personnel to provide clinical expertise.Serve as a conduit from the field to headquarters on any clinical trial project proposals, and be responsible to ensure that Investigative Sponsored Studies are performed.Responsible for the training of new hire MSLs.Helped to develop and implement new, compliant and innovative methods of gathering and managing competitive intelligence.Promoted to Medical Science Liaison II in January 2010.

New York, New York, Us

Medical Communications. Medical information in support of the infectious diseases franchise at Wyeth Pharmaceuticals. Responsibilities included: Training new hires (MSLs, AAMs, and MI Scientists). Respond to unsolicited requests for Medical Information from Healthcare Professionals.

Meadowbrook, Pennsylvania, Us

Clinical Pharmacist in the Oncology Unit

Dive Master, Diving

Pharmd, Pharmacy

Bs, Biology

High School Diploma