Executive Medical Director, Latin America (based in NJ) Job

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Date: May 12, 2014 Location: Summit, New Jersey, United States Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. The Executive Medical Director for Latin America is responsible for coordinating and leading all Medical Affairs functions in Hematology and Oncology across the Latin American Celgene organization. The Executive Medical Director will assure alignment with the global Medical Affairs strategy while working closely with the Medical Directors and personnel in Latin American Country affiliate organizations. The Executive Medical Director will take a leading medical role in the drafting, reviewing and completion of clinical documents in regulatory dossiers for the region, including responses to clinical questions from the reviewing regulatory agencies. RESPONSIBILITIES: 1. Establish a Medical Affairs presence in Latin America: Working closely with the Regional General Manager, Latin America, the Marketing Director of Latin America, the Global Head of Hematology & Oncology Medical Affairs, as well as with the general managers in each country to build local medical affairs departments. Assist in the recruitment efforts for Medical Directors in Latin American countries. Set up procedures deviding responsibilities into regional responsibilities vs. local (affiliate country) responsibilities. 2. Setting the highest scientific and medical standards for the Latin American Medical Affairs group that will be seen as a credible partner by internal and external customers. Drive regional strategy, incorporating insights of specific scientific, medical and business practices and trends, that is consistent with Celgene’s global strategy and is aligned with the country priorities. 3. Support regulatory submissions in the region: in collaboration with colleagues from Regulatory Affairs, Clinical Research and Development, and Drug Safety, draft, review and approve clinical documents written specifically for regulatory submissions in Latin American countries, including responses to clinical/medical review questions from regulatory agencies that come up during the regulatory review. In countries where eCTD is not accepted, assist Regulatory Affairs and Clinical Research and Development in generating the clinical documents required for submissions. Attend meetings with regulatory agencies related to submissions and be prepared to handle clinical/medical questions. 4. Lead all medical affairs activities in the region in close collaboration with the Global Hematology and Oncology and the Corporate Medical Affairs departments and the local medical teams in the affiliates, including the development of regional open-research question, review and administration of investigator initiated trial programs in the region, regional scientific communications, coordination of medical information services, and medical education. 5. Become an expert of all Celgene compounds and ensure the overall knowledge transfer of preclinical and clinical data on Celgene compounds between Celgene’s headquarters and the Latin American organization as it is being built. Establish a broad and deep knowledge base in Latin America. 6. Ensure a consistent and high level training across the Latin American organization with respect to relevant scientific data and knowledge, including SOPs and Working Practices, for Celgene’s international medical team to appropriately conduct clinical research or assist investigators in carrying out Investigator Initiated Trials. This will include development of a training/orientation tool for newly hired as well as a monitoring system to track employee training. 7. Work closely with marketing partners in the region and globally to set the brand and medical strategy for the region and assist with the effective implementation of brand and medical strategies in Latin America, including training for local employees. 8. Ensure seamless and optimal collaboration with local medical teams in Brazil, Mexico and future countries, as well as with our distribution partners, on country specific strategy in alignment with the overall regional and global strategy. Work with the global team to arrive at a coherent international program that medically supports efforts on the national level including activities of the Medical Research Liaison team, medical education and Advisory Boards. 9. Collaborate with Drug Safety and Regulatory Affairs to ensure proper implementation of all Celgene Risk Management Programs. 10. Provide strategic and tactical guidance for clinical teams and allied departments in the region. Ensure strategic alignment of all Development Projects and Brands for Latin America in relation to the global strategy. 11. Work closely with Clinical Research & Development to develop and implement region-specific clinical programs. 12. Ensure optimal safety and clinical overview is provided by associates in all activities in scope, with full compliance with local and global regulatory requirements. 13. Develop and maintain regional KOLs and investigators in clinical studies together with Clinical Research and Development. 14. Coordinate successful development of external contacts (KOLs, influencers and key external customers investigators, academic and regulatory community). 15. Demonstrate commitment to customers by consistently working to understand and exceed their expectations for the delivery of information on Celgene products and messages; in particular to key influencers. 16. Coordinate support from the Medical team for Marketing activities to ensure effective market preparation and education pre- and post-launch. 17. Assist market access in assuring reimbursement in Latin American countries. 18. Responsible for regional medical advisory boards. 19. Responsible for ensuring adherence and compliance to local and global regulations, whilst providing medical support and insights to maximize marketing opportunities. 20. Ensure dissemination of trial-generated and scientifically sound medical information to educate key influencers, including scientific and regulatory leaders. 21. Role model ethical standards and contribute pro-actively to a credible image for Celgene in the local Health Care and Medical community. 22. Responsible for resource planning and management of General Medical and Phase IV/Local Investigator Initiated Trials (IIT) budget. Develop Latin American regional Medical Affairs and track spending against budget. 23. Lead Celgene sponsored regional studies, registries, secondary analyses and 3rd party data resources. 24. Drive talent acquisition, development and retention of team members through strong leadership. Export/rotations across functions and locations. Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. *LI-PM1 Qualifications PREREQUISITES: Medical Degree required with 10+ years pharmaceutical industry experience, including experience in medical affairs in Latin America and experience in supporting regulatory submissions in Latin America. Hematology/Oncology experience essential, and in addition, Medical Affairs or Clinical Development experience in the US is preferred. Fluency (spoken and written) in Spanish and/or Portuguese is preferred. SKILLS: • Medical Degree required; experience in Hematology/Oncology preferred. Experience with Drug Development preferred . • A minimum of 10 years pharmaceutical industry experience is required with at least 5-7 years experience in medical affairs in/supporting Latin America, specifically Mexico and/or Brazil. • Experience with regulatory submissions in Latin American Countries preferred, including interactions with regulatory agencies before and during the submission, as well as drafting of responses to review questions. • Medical affairs or clinical research and development experience in hematology/oncology in the US a plus.Fluent written and spoken English, Spanish and Portuguese preferred. • Superior leadership skills, including demonstrated ability to effectively lead and coach scientific/medical professionals. • Excellent interpersonal, communication, negotiation, and presentation skills. • Demonstrated high level medical, scientific and clinical knowledge. • State-of-the-art medical, scientific and clinical knowledge, encompassing business strategies and market trends. • Strong knowledge base of all aspects of clinical drug development (Phase I-IV). • In depth knowledge of local and global processes in Clinical and Medical Affairs, as well as country specific regulatory, pharmacovigilance ethical and legal guidelines. • Innovative and critical thinking with performance oriented drive. • Accomplished Pharmaceutical Business knowledge. • Highly collaborative with the ability to work across geographical and various departmental boundaries. • Significant understanding of drug approval processes in Latin America, including experience designing and/or executing clinical studies to address local/global requirements. • Current knowledge of and personal relationships with hematology and oncology KOLs in Latin America preferred, with excellent rapport building skills to assist with the development of relationships with both local and international KOL’s. • Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail. • Regular International travel between US and Latin America will be a feature of this assignment and this ability to travel is expected. Req ID: 14001075 Primary Location: United States-New Jersey-Summit Job: Marketing and Sales Excellence Organization: Celgene Corporation Schedule: Regular Shift: Standard Employee Status: Executive Job Type: Full-time Job Level: Day Job Travel: Yes, 25 % of the Time Job Posting: 2014-04-13 00:00:00.0
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