Karen King, Mba, Msj Email & Phone Number

Boston, Ma, Us

Waltham, Ma, Us

Senior Strategist for late-phase clinical assets. Responsible for representing Regulatory Affairs on the maternal and women’s health products, developing regulatory strategies, and managing high-quality submissions to regulatory agencies. Lead, develop, and implement regulatory strategy in order to meet corporate goals and objectives. Report to Senior Vice President of Regulatory Affairs. • Plan global regulatory strategy and prepare regulatory submissions to health authority (HA) applications, such as INDs, CTAs, NDAs, MAAs, related supplements, and responses to questions from health authorities. • Provide guidance and oversight to project teams, collaborating closely with cross-functional colleagues to help ensure that all submissions are timely and of high quality, to minimize HA issues/questions that might impede a projects progress. • Interact directly with health authorities, including FDA, to facilitate assessment of regulatory submissions. • Organize and manage meetings with Health Authority personnel to obtain commitments and agreements enabling rapid and compliant development of new drug programs. • Responsible for regulatory review of promotional and non-promotional material as part of the medical, legal, and regulatory committee.• Work proactively in a cross-functional organization to partner with various other functions to plan and execute an effective regulatory strategy in alignment with the overall clinical development plan. • Identify potential regulatory risks to the strategic/operational plans and propose options to mitigate risks. • Senior leader within regulatory department with management oversight responsibilities for direct reports covering other projects.

Tokyo, Jp, Jp

Accountable for defining and executing the regulatory strategy pertaining to the development and registration of hematology products across the international markets.•Leads cross-functional submission teams to create regulatory documents including marketing authorizations, briefing packages, variation, ODD, PIP, and responses to questions related to regulatory filings•Regulatory lead for all applications conducted in the international regions to ensure timely submission and approval of all applications•Provides regional expertise in collaboration with global regulatory lead in organizing and providing support for meetings with health authorities.•Collaborates with the international local country teams to review, approve, and implement the regional label.•Owns and updates the core dossier•Manage a team of international regulatory product specialists

Illinois, Us

Responsible for developing the regulatory submission strategies including project plans for rest of world (EU, Intercontinental, Middle Eastern and Africa & Japan). Therapeutic areas include Oncology, Immunology, and Hematology.• Oversees the planning of submissions including timelines and status updates• Conducts status update meetings with CMC and regulatory team members for each country• Accountable for setting regulatory plans across regions and harmonizing processes• Align regulatory strategy across all functional areas and distribute tasks within the regulatory • Developed monthly status dashboards for reporting International regulatory deliverables• Streamlined processes for planning and submissions around the world increasing efficiency

North Chicago, Illinois, Us

Lead the regulatory strategic planning for the Oncology therapuetic areas. Create and direct strategies and operations for global matrix teams. • Submitted the Venetoclax NDA and MAA to the FDA and EMA for the treatment of Relapsed iRefractory Chronic Lymphocytic Leukemia (CLL) in previously treated patients with the 17P deletion genetic mutation.• Developed the global regulatory project plan template to drive decisions and planning for submissions and regulatory team activities• Manage multiple projects simultaneously working directly and in collaboration with other cross functional teams• Develop and direct key initiatives to support process improvement• Manage budget preparation, monitoring and communications • Manage metric collection, monthly reporting processes, and vendor contracts• Creates and executes operational recommendations and decisions with a strategic perspective.• Lead regulatory submission strategy for NDA, MAA, JNDA, and rest of world• Coach, mentor, develop, and supervise staff

Thousand Oaks, Ca, Us

• Successfully mastered a very sharp learning curve in a short period of time, to ensure lead company product met its goals on time• Created and facilitated training for department on regulatory and safety processes• Assign Project Managers to manage performance of projects, while working to ensure the ultimate success of the programs across therapeutic areas.• Coach, mentor, develop, and supervise staff of 3 product project managers • Lead efforts for creation of best practices for team resulting in a high performing team• Develop dashboards to manage regulatory strategy across therapeutic areas• Managed components of marketing applications and maintenance of applications; clinical trial applications; responses to regulatory agency questions; pediatric plans; regulatory agency interactions, including briefing documents and meeting preparation; and safety reports and documents

Thousand Oaks, Ca, Us

• Provide management and leadership of GRAAS product project management within Inflammation and Cardio-Renal therapeutic area• To facilitate the development of comprehensive plans and coordinate the execution of GRAAS deliverables• To align and ensure GRAAS project management support of product teams across the area of responsibility• Responsible for managing and developing direct reports

Thousand Oaks, Ca, Us

• Lead the planning and execution of Pregnancy and Lactation Surveillance Programs• Coordinate annual external Scientific Advisory Board meetings • Responsible and accountable for the coordinated management of multiple related projects directed toward strategic business and organizational objectives. • Created web portal to transform the previous archaic intranet into a dynamic website improving team communication and collaboration• Lead projects through legal, compliance, regulatory, and medical review process• Authored role based training curriculum that enhanced team’s job performance • Authored electronic training manual which reduced audit risk and increased efficiency• Build credibility, establish rapport, and maintain communication with stakeholders at multiple levels, including those external to the organization. • Developed web content for external pregnancy website www.amgenpregnancy.com• Manage relationships with external vendors and cross functional departments

Thousand Oaks, Ca, Us

• Assay Qualification Group Meeting Organizer including documentation of meeting agendas and minutes.• Designed and developed training videos to train clinical sites to reduce cost and increase efficiency in training.• Biobank management of normal biomarker samples from whole blood.• Responsible for the technical transfer and cross validation of biomarker assays to contract research organizations and training CRO staff.• Contributed to writing clinical study protocols.• Authored Toxicology reports for IND filings.• Presented data at the annual Department Poster Session.• Increased safety and compliance within the department as Safety Representative

Thousand Oaks, Ca, Us

• Developed and validated human biomarkers assays using various platforms, including ELISA, and Flow cytometry to test biological samples (whole blood, serum, and plasma).• Analyzed samples from FIH clinical trials in validated biomarker assays.• Presented and interpreted data at cross-functional project team meetings.• Designed experiments and analyzed data for micro-array analysis projects• Organized and facilitated bi-weekly working group meeting to share learning and expertise within the department.

Thousand Oaks, Ca, Us

• Developing ELISA based whole blood assays in human, mouse, rat, chimpanzee, and cynomologous monkey for analyzing anti-inflammatory cytokines; small molecules; T cell co-stimulation molecules; and B cell proliferation.• Validated and optimized ECL based whole blood assay for testing inhibitors for inflammatory disease.• Screening of multiple cytokines by Multiplex technology including Cytometric Bead Array and Luminex Multiplex assay.• Designed PCR primers, gene cloning, transfected mammalian cells.• Responsible for updating project team leaders and members of results at monthly meetings.

Goal was to develop a strategic plan for a for-profit shcool to better compete in the current marketplace- Performed a SWOT Analyis and Competitive Analysis to develop understanding of the market- Developed a marketing plan - Develop strategic plan and implementation strategy- Participated on student team of 3

Us

• Isolated dendritic cells for Immunotherapy treatment of Cancer.• Responsible for all Flow Cytometry Studies for project team.• Independently designed In-vivo study protocols.• Engineered expression vectors with virus.• Molecular Cloning and recombinant protein expression.

Msj, Pharmaceutical And Medical Devices Law & Compliance

Mba, Management And Organizational Behavior

Biology

Bs, Organization Leadership, Human Resources Concentration