Santosh Varghese Email & Phone Number

South San Francisco, Ca, Us

Campbell, California, Us

• Expand global product footprint with regulatory and commercial new brand entrants• Expand product indications and grow development pipeline• Collaborate for business development opportunities• Develop Market Access/Pricing & Reimbursement strategies and submissions for Europe in collaboration with the EU General Manager• Partner to launch new business sectors in Europe, LATAM, Asia, and MENA regions• Broad scope of previous clinical, medical, regulatory, and compliance responsibilities remain unchanged

Campbell, California, Us

Title/level promotion, Broad scope of responsibilities remain unchanged

Campbell, California, Us

• Promotion from previous position of Vice President, Medical & Regulatory Affairs, Pharmacovigilance, and QA• Responsible for clinical strategies including Phase 1 through 3, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies, and interactions with corporate partners• Supervise and direct the activities of Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory, and Quality Assurance• Ensures timely medical review and reporting of adverse events• Communicate with the FDA, EMEA, and other Regulatory Agencies including the assessment of regulatory strategy and options• Assess and collaborate with product/company alliance partnerships• Oversight of both corporate and manufacturing Quality Assurance functions • Oversight of company SOPs and compliance activities to ensure alignment with federal, state, and local regulations • Participates as an active member of the executive team of the company• Work with Marketing to support approved products through Medical Affairs activities• Work with cross-functional internal partners to evaluate new product candidates, determine product indications, develop development strategies, and design post-marketing studies, as appropriate• Reporting to the CEO – Direct staff of 11

Campbell, California, Us

• Title adjustment as of October 2013 to reflect new responsibilities in Regulatory Affairs and Quality Assurance related activities• Title adjustment as of July 2013 to reflect new responsibilities in Commercial Compliance activities, State and Federal reporting requirements, and Sunshine Act related activities• Designated Representative-in-Charge for California State Board of Pharmacy Wholesaler License, Responsible person for Wholesaler License• Global & U.S. Medical Affairs and Pharmacovigilance• Obesity/Metabolism and Men’s Health Therapeutic Areas: Qsymia (US), Qsiva (EU), Stendra (US & EU)• Support, provide scientific/medical brand strategy to US & Global Teams (Brand Team, Medical Directors, Medical Communications Managers, Medical Information Managers, Publications Managers, Study Managers/team, Medical Science Liaisons, and Consultants)• Oversight of Medical Operations/Medical Information Department who is responsible for medical and scientific dissemination within the company, to the scientific/medical community, and to the general public• Oversight of Field Based teams (Clinical Science Liaisons and Field Medical Directors)• Develop, validate, and prioritize Medical Affairs plans including Phase IIIb/IV • Review of manuscripts, abstracts, posters, etc.• Advise in the development of Scientific Symposia and Advisory Boards• Oversight of Grants, CME, and Investigator Initiated Trial review and approval processes• Provide input into Development & Pipeline product plans• Participate in reviews of proposed and ongoing projects, new product development, and licensing opportunities• Support medical and scientific key opinion leaders, advocates, and interactions with medical societies• Provide input for safety reports & reviews• Provide input for labeling and interact with the FDA and EMEA as needed• Manage alliance partnerships for Medical Affairs & Pharmacovigilance• Reporting to the CEO – Direct staff of 25

Dublin 2, Ie

• Global & U.S. Therapeutic Head for BioNeurology franchise: Tysabri• Support and provide scientific/medical brand strategy to US & Global Teams (Brand Team, Medical Directors, Medical Communications Managers, Medical Information Managers, Publications Managers, Study Managers/team, Clinical Science Liaisons, and Consultants).• Supervise Medical Communications Department who is responsible for medical and scientific dissemination within the company, to the scientific/medical community, and to the general public.• Supervise and provide direction to Field Based teams (Clinical Science Liaisons and Field Medical Directors).• Develop, validate, and prioritize Medical Affairs plans including Phase IIIb/IV clinical plans. • Supervise clinical trial development from concept to synopsis to full protocol.• Medical consultant to ongoing Phase IV clinical trials. • Supervise development of manuscripts, abstracts, posters, and clinical study reports.• Review and approve manuscripts, abstracts, posters, etc.• Advise in the development of Scientific Symposia and Advisory Boards.• Oversight of Grants, CME, and Investigator Initiated Trial review and approval processes.• Provide input into Development & Pipeline product plans• Participate in reviews of proposed and ongoing projects, new product development, and licensing opportunities.• Develop and support medical and scientific key opinion leaders and advocates.• Manage interactions with medical societies.• Provide input for safety reports & reviews.• Provide input for labeling and interact with the FDA as needed.• Manage product/company alliance partnerships as they relate to Medical Affairs.• Supervision of Medical Affairs staff: performance evaluations, coaching, mentoring, development, and other HR related activities.• Reporting to the Chief Medical Officer/EVP, Head of Global Development – Direct staff of 35.

• Provided medical/clinical insights for various therapeutic areas including: Allergy, Respiratory, Immunotherapy, Anti-Infectives, Women’s Health/Gynecology, Cardiovascular/Thrombosis/Metabolism, Men’s Health, Reproductive Endocrinology, Osteoarthritis, Rheumatoid Arthritis, and Device Technology.• Provided Medical Affairs organizational consulting services

• Primary Care includes Allergy, Respiratory, Women’s Health, Fertility, Men’s Health, and Mature Brands.• Global & U.S. Medical Affairs Therapeutic Head for Allergy, Immunology, & Respiratory franchise (Clarinex, Claritin, Nasonex, Asmanex, Proventil, Foradil, Elocon, Allergy Immunotherapy Tablets); Cardiovascular franchise (Integrilin, Zetia, Vytorin, Olmetec); Men’s Health franchise (Levitra, Andriol); Women’s Health franchise (Nuvaring, Implanon, Implanon NXT, Cerezette, Livial, NOMAC/E2); and Fertility franchise (Follistim/Puregon, Orgalutran/Ganirelix, Corifollitropin alfa).• Validated and prioritized Phase IIIb/IV clinical plans for primary care and cardiovascular portfolio of products.• Participated in multiple Development Committees (Cardiovascular, Women’s Health, and Primary Care) which review proposed and ongoing projects, new product development, and in-licensing opportunities. • Supervised, coached, and mentored direct reports.• Developed and supported medical and scientific key opinion leaders and advocates.• Managed interactions with medical societies in multiple therapeutic areas.• Oversight of clinical trial development from concept to synopsis to full protocol, and finally clinical study report.• Medical consultant to ongoing clinical trials.• Supported and provided scientific/medical brand strategy to US & Global marketing teams, country level Medical Directors, Medical Education Managers, Publications Managers, Study Managers/team, Medical Scientific Liaisons, and Consultants.• Managed medical and scientific dissemination within the company, to the scientific/medical community, and to the general public.• Advised in the development of Scientific Symposia and Advisory Boards.• Reviewed and approved manuscripts, abstracts, etc.• Provided input for labeling and interacted with the FDA as needed.• Managed product/company alliance partnerships as related to medical affairs.

Paris, France, Fr

• Acting Global Medical Director – Allegra & Nasacort• Acting Clinical Director – Nasacort• Assisted in the US brand strategy.• Developed, validated, and prioritized Phase IIIb/IV Medical Affairs plan.• Provided scientific/medical direction to US marketing and provided support to field based Medical Liaisons. • Supervised and gave direction to in-house Medical Directors, Scientists, Medical Education Managers, Publications Managers, and Study Managers/team.• Clinical trial development from concept to synopsis to a full protocol.• Medical consultant to ongoing clinical trials.• Developed clinical study reports.• Managed medical and scientific dissemination within the company, to the scientific/medical community, and to the general public.• Advised in the development of Scientific Symposia and Advisory Boards.• Reviewed and approved manuscripts, abstracts, etc.• Developed and supported medical and scientific opinion leaders and advocates.• Managed interactions with medical societies.• Provided input for labeling and interacted with the FDA as needed.• Managed product/company alliance partnerships as related to medical affairs.

Paris, France, Fr

• Senior Principal Scientist for Lovenox at Aventis Pharmaceuticals• Developed protocols for Phase IIIb & IV trials.• Interacted with physicians and investigators for trial design and conduct.• Reviewed study budgets and ensured adherence to study timelines.• Oversight of Investigator Initiated Trial program.• Developed Standard Operating Procedures (SOP).• Interacted with Clinical Operations, Biostatistics, Data Management, Safety, and other key functional groups in implementing a successful trial (CRFs, informed consent, statistical analysis plan, etc.).• Ensured studies are conducted according to ICH/GCP regulatory guidelines.• Reviewed study data and completed the final study report.• Interacted with Medical communications in manuscript completion and abstract submission.• Supported the updating and maintaining of Medical Affairs Standard Operating Procedures (MASOP).• Provided medical and scientific support for the Marketing group.• Reviewed therapeutic area/medical information with key thought and opinion leaders.• Provided input at all levels to enhance product line superiority.

Raleigh, North Carolina, Us

• Manage full-scope Phase II, III, & IV pharmaceutical projects from the planning to analysis Phase for delivery to the client.• Serve as primary client contact.• Prepare the project plan/timelines and monitor progress.• Coordinate project organization, implementation, and management activities between all functional areas and the client.• Establish appropriate project tracking using computer-assisted programs.• Develop Project Specific Operating Procedures with functional areas.• Evaluate and manage project budget milestones and profitability.• Conduct monthly project team meetings.• Prepare weekly and monthly status reports.• Additional functions: Medical Liaison/Officer - Perform safety reviews, Medical advice to project team, Medical consultation to sponsor, and Business presentations.• Therapeutic Areas: Infectious Diseases, Skeletal Disorders/Arthritis, Respiratory Diseases/Asthma, Cardiovascular

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Md, Medicine

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