Curt Johnson Email & Phone Number

Cambridge, Cambridgeshire, Gb

• Led global cross functional teams in the planning and delivery of major global submission(s): creation and development of project and risk plans, monitoring of progress and issue resolution; establishing reviewer matrices; resource decisions; regulatory defense; regulatory inspection readiness preparation• Led global cross-functional team in the planning and delivery of the emergency use application (EUA) and conditional marketing application (CMA) for a Covid long acting monoclonal antibody • Led development, baselining, and maintenance of realistic & appropriate submission, project, and study plans (including timings, cost, and budget) for various programs. • Planned & facilitated Clinical Project Team (CPT) meetings and reported to the Global Project Team (GPT) and other senior stakeholders on an as-needed basis. Lead development of CPT objectives.• Provided extensive budget, FTE, and planning information to the GPVP in support of partnering discussions being held in Europe for the Movantik project.• Led planning, and strategy for extensive global at-home nursing support and sample shipment for the a major Ph III COPD study.• Led the development of clinical operations aspects of life cycle management (LCM) indications• Served as the Director Clinical Development (DCD) for the established neurosciences portfolio including all periodic safety reporting, addenda to clinical overviews, NDA annual reports, and license to operate renewals.• Provided product knowledge and expertise to the process of contracting out clinical studies through the SCOUT model and served as the single point of contact for CRO partners. • Developed model for the GCOPD, the global medical communications lead, and the regulatory project manager to work together in submission management and regulatory defense.• Created and developed a clinical guidance document, a process flow diagram, and a generic project plan for teams to use in planning the 4-Month Safety Update (4MSU).

Cambridge, Cambridgeshire, Gb

1.) Lead the planning and delivery of defined clinical projects or work packages and provide expert project management skills to Clinical Development. Scope includes delivery of work from early development through to submission and regulatory packages for drug projects (this includes deliverables for complex sub-projects such as multiple indications, Life Cycle Management (LCM) opportunities, formulations and work on early development teams) as well as non drug projects (i.e. Change or Continuous Improvement projects). 2.) Lead and/or actively participate in submission assembly teams, regulatory response teams and lead or actively contribute to Advisory Boards and Steering Committees activities as necessary. 3.) Lead the development of delivery scenarios and options that include an assessment of the main risks together with mitigations and contingencies. 4.) Develop, maintain, & leverage realistic, risk-managed plans. 5.) Responsible for project budget and scope; including the definition and management of total costs and project scope and the delivery of the project within the approved budget and resource.6.) Identify and secure appropriate resources, in partnership with the relevant line managers across various departments, to ensure efficient and timely progression of agreed deliverables.

Cambridge, Cambridgeshire, Gb

1.) Lead document production and manage medical communications teams (both internal and contract writers) for major submissions (NDA, MAA, regulatory defense) in oncology and respiratory, cardiovascular, & inflammation therapeutic areas.2.) Author clinical regulatory documents including clinical study reports, IBs, all clinical CTD documents (for NDA and MAA), regulatory defense, briefing documents, regulatory response documents, IMPD, 4-month safety updates, 90-day reports, survival updates, FDA advisory council briefing packages and slide sets, REMS, etc...2.) Provide review and advice on clinical study protocols, case report forms, statistical analysis plans, clinical development plans, IND components, etc... 3.) Project management skills to develop and manage timelines and project plans; delivery of contributions across functional groups; and coordination of reviews, resolution of issues, finalization and publishing of documents, etc4.) Manage contract writers, define scope of work for contracts, ensure delivery of work from contractors to time and quality, negoatiate changes (including additional charges) to contracts, act as liason between contract writers and in-house teams.5.) Develop best practices for medical communications including document templates, reporting standards, authoring instructions, and creation/revision of SOPs.6.) Develop training materials for external service providers (ESPs) working on prjects for the company; evaluate the training and work of ESPs and provide feedback to improve quality of deliverables received.

New York, New York, Us

Wrote various clinical-regulatory documents for oncology and women's health projects including clinical study reports, IND annual updates, investigator's brochures, regulatory response documents, and various NDA documents (summaries of safety and/or efficacy).

Gaithersburg, Maryland, Us

Wrote Phase I clinical study reports, produced slide sets, and organized content of searchable databases.

Us

Wrote patient narratives, Phase I and II study reports, and IND annual updates.

Us

Medicinal organic chemist

Abbott Park, Illinois, Us

Medicinal organic chemist working on nicotinic receptor compounds for pain management.

Geneva, Switzerland, Ch

Medicinal organic chemist working on products for the treatment of glaucoma

Wilmington, De, Us

Mba, Health & Medical Systems Administration

Ms, Interdisciplinary Environmental

Ba (2), Chemistry; German