Kaiser Pathan MD MBA FACP

**** ******* **

Bethlehem, PA 18020

201-***-****

acx2py@r.postjobfree.com

PROFILE

Accomplished with business focused with pharmaceutical experience offering 15+ years of experience medical affairs Lead and Manage all US Medical Affairs programs and activities internally within corporate and externally with FDA regulatory guidelines and approved budgets. Extensive interaction with senior management, outside experts, corporate partners, key opinion leaders and the FDA in regards to strategic planning. Lead development and execution of a US medical launch plan portfolio in the United States and Europe. Overseeing the strategy, training and education of the field medical teams.

Therapeutic experience Oncology, Rare Disease, Cardiovascular, Anti-infective, Rheumatology, Gastroenterology, Dermatology, Neurosciences, Immunology, Ophthalmology, Women’s Health and Respiratory.

As a science expert, industrious, great communicator, and highly effective in providing vision and counsel in all stages of a product life cycle, and training of internal teams. A proven performer and multi-tasker who thrives on challenges, delivers results under pressure, and gets the job done – consistently meet or exceeding expectations.

CORE MEDICAL AFFAIRS SKILLS

Communication

Teamwork

Planning and Organizing

Accountability

Client Orientation

Commitment to Continuous Learning

Knowledge

Leadership

Vision

Empowering Others

Building Trust

Managing Performance

Judgment/Decision Making

Business Acumen

CAREER SYNOPSIS

01/2015 – Present, Integra Life Sciences Plainsboro, NJ (Consultant)

Interim Head of Global Medical Affairs Officer

Expand the existing thought leader and key expert data base;

Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders;

Regularly update the scientific Platform and Slide Compendium as new data and updates to treatment guidelines become available;

Develop medical education activities;

Provide medical review and approval on promotional materials;

Participate in the creation, review and finalization of Sales training materials;

Execute on the publication plan;

Manage investigator initiated research or CME grant applications;

Support managed care / access and reimbursement / payer advocacy projects through pharmaco-economic analyses and advisory board participation;

Supervise and manage the Pharmacovigilance (PV) and Medical Information (MI) vendor, working closely with Regulatory Affairs, Clinical Development and Legal to ensure compliance with the Company’s post-marketing PV and MI obligations;

Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.

Build the Medical Affairs infrastructure to support launch:

Personnel hiring

Secure a PV and MI vendor and initiate system set-up.

Ensure execution of the scientific communication platform and medical education activities:

Journal manuscript submissions for the phase3b, phase 4;

Accelerate medical education activities through digital and conference platforms;

Initiate the advisory board program for 2016;

Build a promotional materials review and approval process with Marketing and Legal;

Participate in the identification and prioritization of life-cycle management options;

Participate in the completion of the European clinical development strategy – contingent on timing of EMA outreach activities;

Participate in Business Development activities as needed;

Participate in the Company pipeline review and prioritization process.

11/2013 – 12/2014, AbbVie Inc. Chicago, IL (Consultant)

Executive Director Global Medical Affairs – Rare Disease

Develop the medical vision and strategy for molecules/products across the assigned Rare Disease portfolio

Overseeing multiple, often large-scale post-marketing trials, studies, investigations, other projects and programs for the assigned portfolio to ensure all activities are completed on time, to high standards

Contributing to the long-term vision, strategy, plans and results for the overall U.S. Medical Affairs organization and the assigned therapeutic area(s)

Proactively identifying and leading cross-functional projects and initiatives that carry broad impact across Medical Affairs

Representing Medical Affairs on multidisciplinary teams

Acting as an expert advisor to internal committees, management and teams regarding strategic medical issues and lifecycle planning

Providing expert leadership guidance and input Lifecycle Management, Lifecycle Plans, 3-year and 1-year brand/tactical plans for all molecules/products in the assigned portfolio

Acting as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions

Compliantly developing and cultivating long-term strategic partnerships with thought leaders and other external stakeholders

Inspiring your team, recruiting, developing and retaining talent and ensuring a strong succession plan for key positions

Hire, develop and oversee the work of your direct and indirect reports

Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate- and longer-term

Act as part of the assigned USMA Medical Unit Leadership Team and play a key role in cross-functional planning and decision-making

Develop/lead organizational design, resource requirements, compensation, expense budgets, immediate-, medium- and long-term capacity for the assigned Medical Affairs function and team

Provide vision and strategic direction to team

Advise senior leadership, direct reports and others internally and externally on strategic medical issues and considerations

Act as a key contributor to or lead for peer review sessions; includes acting as a frequent reviewer in internal review/decision-making committees

Oversee and guide development of post-marketing medical strategies and Medical Plans

Provide critical, strategic insights and recommendations across multiple medical projects and other activities

Work with team and therapeutic counterparts in Abbvie and global groups to align Medical Plans, goals and objectives at the affiliate, regional and global levels

Assign team members as Medical Team Leads and as standing or ad hoc members of Global Medical Affairs teams, other core and sub-teams. Ensure appropriate and adequate representation across teams relevant to assigned portfolio

Member of the relevant Global Medical Affairs Team and Joint Executive committees, which include global partner functions as well as external collaborator personnel

Act as expert participant and contributor on advisory boards and presenter at other external forums

Provide medical affairs support for Phase III clinical trials

Consult to Business Development on relevant acquisitions, joint ventures or other strategic partnerships

Develop and deliver presentations, both internally and externally, to convey the medical perspective and provide updates on activities relevant to assigned portfolio or therapeutic area

Attend and contribute at major scientific and medical conferences

Provide medical affairs input into competitive intelligence activities and projects

Provide expert review of published scientific and clinical literature

Oversee medical programs and tactics across multiple projects. Direct others in developing and executing medical strategies, trials, other studies and investigations, communication, education, health economics and outcomes research and publication activities over a range of products within the assigned portfolio

Oversee and guide design, execution and data interpretation of post-marketing clinical trials and other post-marketing medical investigations or studies

Provide ongoing guidance on the overall strategy and prioritization of medical plan activities across the assigned portfolio

1/2013-11/2013 Boehringer Ingelheim Ridgefield, CT (Consultant)

Senior Medical Director

• Provide strategic US Medical input to Global Development on medical/clinical development (Phase II - IV), pre-registration, label extension, pre- and post-market launch strategies, and life cycle management.

• Attend scientific meetings and foster and develop strong relationships with investigators.

• Leverage strong science in the development and launch of commercially viable products utilizing aggressive timelines; integrate scientific rigor, medical need and commercial value into compelling strategies in support of successful registration and marketing.

• Identify and implement high value strategies for product life cycle development and expansion across the entire portfolio.

• Contribute to the development of new indications for existing products.

• Develop and implement reliable and high-value communication strategies for new and existing products.

• Team responsibilities include U.S. medical affairs support for in-line and pre-launch products, including strategic and tactical planning and design, implementation and timely completion of Phase 4 studies and addressing post-marketing concerns.

• Work in, and enable a positive team environment and interact with global clinical, scientific and marketing teams.

• Prioritize and resource pre-market launches and post-market medical programs.

• Successfully create a bridge between clinical development teams and provide medical expertise to the commercial product development teams.

10/2011 – 12/2012 NPS Pharmaceuticals Bedminster, NJ (Consultant) Sold to Shire

Vice President of Medical Affairs (report to CMO)

Rare/Orphan Disease Endocrine Natpara Hyporparathyroidism, Gattex Short Bowel Syndrome.

• Led the day-to-day activities of the Medical Affairs organization of strategic planning and implementation of for Endocrine, Rare Disease product created a new departments within medical affairs.

• Interact with stakeholders in the field (experts and investigators, country Medical Affairs, medical monitors, CROs) to drive the design, deployment and execution of the assigned studies

• Develop and lead, interpret and communicate assigned Global Medical Affairs studies

• Ensure internal communication of progress and results of studies in area of responsibility

• Work closely and coordinate activities with phase 4 study manager and medical indication lead

• Control budget and ensure timely implementation and reporting of PAT progress and results for the assigned studies

Direct reports include a Head of MSLs, a Medical Director, Oncology and a Medical Director, Rare Genetic Disorders.

Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems in office and field-based locations.

08/2010- 09/2011, Genentech Inc. (Roche) South San Francisco, CA

Senior Director Global Medical Affairs

Created the first worldwide Medical Oncology group delivering consistent, compliant and high quality medical responses. Launch Zelboraf. LCM Herceptin, Avastin, Xeloda, Rituxain.

Established a global Medical Publication network improving publication quality and compliance

Implemented a system improving publication quantity and transparency corporation wide.

Led creation of the first worldwide medical information and knowledge system providing simplified access to document repositories and inquiry management

High levels of partnership and collaboration with other teams and divisions to share benefits across

Led clinical trial portals, online patient recruitment, and other medical communication teams and activities worldwide

Accountable for leadership and direction of a Medical Information Therapeutic Area Team, including leadership of a therapeutic area strategy, routine management of team members, optimization of resources, best practice sharing, planning and alignment of priorities.

As a member of the Medical Information Leadership Team, contribute to the development of the Medical Information strategy and objectives.

Accountable to Medical Information Senior Director to ensure Therapeutic Area objectives are aligned and Medical Affairs business and strategic objectives.

Represent Medical Information on the Medical Affairs Therapeutic Area Leadership Team to ensure Medical Information objectives are incorporated into the Therapeutic Area Strategy.

Accountable for the integration and management of applicable Medical Information deliverables including management, metrics and analysis, and project management.

Enables best practice sharing and consistent use of commonly defined processes, tools, and templates.

Facilitates timely and effective decision-making within the Therapeutic Area Team.

Provides business and resource planning leadership for Medical Information.

Support the collaboration with key stakeholders to identify creative and innovative approaches to scientific information delivery.

Anticipates leadership development needs through demonstrated broad business perspective and effective needs analysis.

Provides analysis and expertise to facilitate timely and effective decision making for Medical Information resource planning and management (eg, budget); business planning and strategy; and policy decisions to anticipate and/or resolve risks/issues.

Coordinates with Medical Affairs Leadership to develop, manage and maintain processes and technologies that maximize effective and efficient delivery of scientific content.

Responsible for the development or review of processes, guidance, job aids, and related documents for Medical Information.

Collaborates with global teams on Medical Information processes including Global Medical Information.

05/2001 – 03/2010, Pfizer Inc. New Jersey and New York City

01/2008 –03/2010 External Medical Director Global Communications

Full member Infectious Disease/Oncology matrix team. Liaison between internal/external stakeholders (Health Economics & Outcomes, Clinical Science, Regulatory, Legal, Managed Care Marketing, Field Managed Care, Medical Science Liaison, Sales, Marketing, Access group, and Corporate Partners) to provide competitive intelligence and dissemination of information.

Lead for Erxis, Viagra PHTN, Sutent, Exubra Inhaled Insulin from Pre-Clinical to Launch.

Manage the Medical Communication Database (MCD), including the analysis of metrics and ongoing enhancements to ensure excellence in customer service, accuracy, efficiency and quality

Manage the development of scientifically balanced, well-referenced standard medical content used for responses to medical inquiries for global products

Manage the global Medical Information TA Leads who lead the creations of strategic development plans and medical information/content for global products.

Ensure compliance and transparency within MI processes and procedures in alignment with Legal/Regulatory/Compliance and Regions

Collaborate with groups outside companies (co-marketing/co-development partners, licensees) and ensures knowledge sharing

Ensure direct and consistent communication with departments such as Global Pharmacovigilance (GPV), QA, RA, Region Medical Affairs, Legal, and Compliance

Ensure that appropriate global Standard Operating Procedures (SOP)/Working Practice Documents (WPD) are developed as required for Medical Information departments globally, ensuring alignment of regional extensions to governance documents

Direct the Medical Communications budget

Manage virtual library including: meeting requirements for literature searching for stakeholders in Global, Region and Country Medical Affairs ; education on the use of virtual library services; document delivery; comprehensive subscription packages; and global sharing of subscription packages. Analyzes existing services and ensures strategies to improve value.

Develop strategic initiatives to improve efficiencies and quality output; anticipates need for implementing initiatives to comply with new policies (internal and/or external)

Ensure full compliance with GPV expectations on routine literature searches on the safety of Pfizer drugs

Develop solid, scientifically-based Disease Overviews, product summaries and competitor reviews to support Core Medical Teams and Global Product Strategy Teams

Conduct real-time Scientific Intelligence, through attendance at relevant Conferences/Congresses, creation of informative summaries (to strengthen global medical strategies and tactics), and proactive dissemination of summaries to Commercial and Medical internal stakeholders

Oversees a team of 15 - 20 employees globally, including Senior Director-level reports

Monitor a budget.

Impacts compliance with: regulatory/safety/legal requirements of global governmental agencies, Pharma code, and internal Pfizer policies

Responsible for creation of a community across global, region and country MI personnel

In collaboration with Legal responsible for enforcement of publication policy standards (Pfizer Publications Policy i.e., SOP CT37, ICMJE guidelines, Pfizer Corporate Integrity Agreement, HCP Engagement SOP, etc) and communication of any policy standards changes

Serve as coach to PSC members on publication planning and execution

Routinely trains the PSC regarding publication policies and guidelines

Coordinates the development of a publication plan for a number of products within the established business planning cycle. Using publication planning/product knowledge and experience contributes to the development of the publication plans

Serves as a consultant to the Publication Subcommittees (PSC) on selection of appropriate journals and congresses for scientific data submission

Supports the efficient execution of the plan in adherence with policies and procedures Monitors and evaluates overall publication plan goals and objectives by product and makes recommendations for improvements where needed

Works closely with the Medical leads for each product to ensure successful development and execution of the publication plan

Identifies and drives metrics, tool refinement, process improvement and sharing of best practices to further enhance the efficiency of the publication processes.

Accountable for the effective use of a standardized publication planning tool (Datavision)

Establishes and manages assigned-product publication budgets within Medical Affairs. Partners with Finance to maintain/monitor publication budget forecasts.

Collaborates with Pfizer Procurement around vendor selection, contracting and ongoing monitoring of vendor relationships

Works in a vendor-facing role to communicate key information and requirements to Publication Agencies

Works with Publication Agencies to educate them on established Pfizer Publication policies and procedures

Takes a lead role with vendors in facilitating issue

Provided support for designing and participated in delivering clinical presentations at Advisory Boards

Content development/scientific review of content and presentation materials

Working knowledge of project management practices and processes

Management of direct reports

Collaborated with the MSL/clinical scientist to establish and maintain relationships with KOL through the dissemination of scientific information on both preclinical and marketed products.

Created, maintained and oversaw the approval process to manage Scientific Presentations, Publications, and other medical literature.

Member of the grant committee to ensure that Investigator Initiated Trials grants and Educational grants are aligned with corporate goals and in compliance with pharmaceutical industry guidelines

Prepared and provided responses to unsolicited requests using many communication formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.).

Created the medical communications operating plan for each assigned products.

Provided direction/guidance to staff and participated in activities related to commercial/brand product support. Coordinated departmental participation in related activities for the purpose of ensuring medical accuracy, current and fair-balance of promotional materials.

Led therapeutic team in absence of team leader.

Co-Chair of the Promotional Review Committee and worked with marketing, regulatory and legal departments to review promotional and other product materials in accordance with DDMAC regulations.

Co-Chair of the Global publications team.

Provided medical input to all aspects of product development and promotion for entire product lifecycle.

Collaborated with the MSL/clinical scientist to establish and maintain relationships with KOL through the dissemination of scientific information on both preclinical and marketed products.

Created, maintained and oversaw the approval process to manage Scientific Presentations, Publications, and other medical literature.

Member of the grant committee to ensure that Investigator Initiated Trials grants and Educational grants are aligned with corporate goals and in compliance with pharmaceutical industry guidelines

Provided input into the development and implementation of MI strategy, processes, and systems.

Participated in taskforces: website www.pfizerpro.com, Outsourcing Call Center India and Europe.

Led taskforces: Continuous Improvement, Video Detailing, and Key Performance Indicators (Stakeholder impact, Cost per inquiry, External Awareness Campaign, Social Networking), and Department Offsite.

Established and maintained strategic direction for the TA in close coordination with Vice President.

Responded to escalated product inquiries from CEO/Executive, resulted excellent customer service.

Member of Acquisition/Integration teams: Wyeth Integration Team, Pharmacia Ophthalmology team,

Coordinated, developed and delivered custom formulary dossier preparation and to ensure information provided to managed care organizations, private and government health plans, third party payors, pharmacy benefit managers, specialty pharmacies, compendia publishers, and technology assessment entities.

Coordinated, updated, and reviewed clinical product data, identified relevant data for submission to drug information and formulary organizations as part TA team.

Participated in the online physician network site (Sermo and Eprocates).

Product launches-Dalbavancin & Toviaz. Product coverage-Eraxis, Zyvox, Detrol, Sutent, Camptosar, Aromasin.

1/2005 – 1/2008 Medical Information Manager

Promoted two levels up in the management as a Medical Information Manager.

Provided fair balanced scientific information to KOLs, cardiologist; actively participated in the pre-launch activities of Zoloft, Geodon, Neurontin, Clebrex, Bextra, Lyrica, Tikosyn, Lipitor;

Provided clinical data to pharmacy directors and facilitated the AMCP dossier for the managed market accounts and Medicaid in all the states; presented published clinical data at journal clubs;

Facilitated company-sponsored clinical studies, actively participated in complex disease management issues regarding melanoma, and GBM; facilitated advisory boards; successfully managed Global Medical Affairs booths at conventions and symposia; ;

Trained anti-infective and oncology sales representatives. Critically evaluated medical literature against key competitors and created medical responses and tables for consumers and healthcare professionals.

Facilitated the development and maintenance of formulary-related documents in support of improving access to state Medicaid and managed care formularies

Defined productivity metrics on medical information call center workflows/department operations, and presented clear and concise trending reports.

Supported Global counterparts by ensuring open exchange of product information, business intelligence, and best practices.

Participated in the strategic direction and operating model of the Global Medical Library

1/2002 – 1/2005 Senior Medical Information Specialists

Promoted to Senior Medical Information Specialist for providing support to cardiology franchises. Provided high quality and accurate scientific information to external and internal customers in the USA, and internal customers worldwide; developed standardized written/verbal responses to address unsolicited requests from health care professionals;

Collaborated cross-functionally with Marketing, Managed Care, Legal, and Global Regulatory Affairs to ensure consistent brand messaging, and resolved issues relevant to the therapy areas; part of the team to review promotional materials and ensure FDA compliance;

Constantly updated medical information letters and made them in sync with the latest publications; prepared slide decks for oncology and CV MSLs to assist them in presenting complex data to health care professionals; participated in Medical Affairs planning meetings and provided customer insights and trends related to therapy areas.

Quality Assurance of escalated cases; provided feedback and training specific to assigned therapeutic category to ensure the maximum possible numbers of inquiries are handled at the first level.

Provided product training and presentations to colleagues and sales force.

Participated taskforces: Pfoenix inquiry Management System, Medical Communications website (www.pfizermedicalinformation.com)

Participated in the MSL training and attended advisory board meetings.

Participated in Taskforces Career Ladder, Develop Metrics and preceptorship of pharmacy students.

Member of acquisition/transitional teams: Vicuron pharmaceutical Inc. and Eyetech Inc.

Responded to escalated MI inquiries AE or complaints from CEO/Executive, and US and Global colleagues’.

Analyzed utilization reports generated from customer experience through calls and contacts.

Developed and ensured execution of medical and scientific convention and conferences and managed the medical affairs booth including providing medical intelligence activities.

Presented at Pre Conference and debrief sessions with medical, sales and MSL.

Ensured compliance to the required timelines, budget and regulatory environment

Launched product of Macugen. Product coverage Lipitor, Sutent, Camptosar, Aromasin.

5/2001- 1/2002 Medical Information Product Specialist

Performed product quality and adverse events intake for all the prescription products; educated patients on the proper use of specialty products; worked closely with patient assistance program and ensured un-interrupted supply of medicines to needy patients; demonstrated 100% compliance in processing all the product quality complaints and adverse events as per FDA guidelines;

Won accolades and awards for providing unparalleled service to customers.

Managed Team and establish the processes, objectives for therapeutic team.

Authored and Complied the Zyrtec American Managed Clinical Pharmacy(AMCP) 1.0 dossier

Trained colleagues in Adverse Event Reporting for the Safety AE Reporting Group.

Oversaw development programs for MI Call Center to ensure departmental objectives for quality and efficiency were met or exceeded.

Member of Acquisitions team: Parke – Davis transition team and Warner Lambert.

Product coverage: CNS, Cardiovascular, Men’s Health,

01/2001 – 04/2001 Drug Information Manager

Joined the company as a member of the team of doctors who were working on different projects on behalf of leading pharmaceutical companies; participated in the launch of ‘Zithromax’, ‘Viagra’, and ‘Zyrtec;

Engaged in peer-to-peer discussions with the health care professionals and helped them understand the new products and treatments;

Worked on a special project to interview physicians about their needs for training regarding a special treatment, and then arranged visits by the company's representatives to train those physicians, thus enabling the company to effectively utilize their limited resources and contain costs.

Accomplished medical communication objectives for customer satisfaction, responsiveness, cycle time and quality standards by managing personal productivity and by timely and appropriately responding to medical communication inquiries and escalating cases as appropriate.

Diligently evaluated cases for Adverse Events (AE) and Product Complaints taking appropriate action in compliance with company policy.

Responsible for products complaints.

Identified crisis event, trends and shift in inquiry volume, provided recommendation to Senior Director.

Participated in projects as required (e.g., serve as advisors for relevant SOP development).

Attended meetings and participated in other activities to support business goals and initiatives.

1/1998 – 01/2001 Newark Beth Israel Hospital, Newark, NJ

Medical Toxicology Management Specialist

Attending Physician and Conducted clinical trials phase 2 and phase 3b for Roche.

Consultant to 183 Emergency Rooms, Physicians, health care providers, public in the management and treatment of overdose and toxicity of pharmaceutical, oncology, OTC, narcotics and street drugs, poisons, plants, household and environmental chemicals in a busy call center environment.

Conducted faculty meetings of teaching hospitals; Conducted Morning Report and presented toxicology overdose cases at hospital grand rounds.

Advised Emergency Room New Jersey hospitals. Contacts with main academic centers NYC, NJ.

Managed a team of health care professionals in the Pharmacovigilance team.

Conducted Morning Report and presented toxicology overdose cases at hospital grand rounds. Participated in and gave presentations in community health fairs on toxicology

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