Basic Qualifications:

• M.D. Degree

• Minimum 3 years total experience in international pharmacovigilance

Preferred Requirements:

• Prior safety analysis documentation and experience responding to Health Authorities

• Board Certified/Board eligible, or equivalent, is preferred

• Excellent clinical judgment

• Capability to synthesize and critically analyze data from multiple sources

• Ability to communicate complex clinical issues and analysis orally and in writing

• Able to develop and document sound risk assessment

• Demonstrates initiative and capacity to work under pressure

• Demonstrates leadership within cross-functional team environment

• Excellent teamwork and interpersonal skills are required

• Fluent in English (written and spoken).

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Signal Management Officer

The primary function of the Signal Management Officer (SMO) role is to coordinate signal detection, prioritization and evaluation/analysis processes within GPE and in collaboration with functions outside GP for products under development and for marketed products.

The SMO responsibilities will include:

• Provide medical advice on signal detection and evaluation processes for Medical Safety Evaluation and PV Operations teams
• Contribute to the development of the signal detection tools (standard and specific queries) and business processes, become and expert of the tools and to contribute to the training of GPE collaborators using the tools
• For certain products, to be responsible of the signal management of the products (to evaluate the AEs for potential signals and liaise with the Medical Safety Evaluation group to ensure evaluation of identified signals, and the Risk Management group to implement risk management measures if necessary)
• Contribute to the development of the system ensuring that potential safety signals detected are allocated and addressed, and make sure that they can be easily monitored by GSOs and GSAs responsible for the respective products
• Develop a tracking system of GPE activities on signal detection and evaluation, including conclusions of any relevant signal investigated/assessed and any subsequent measures taken.

The successful candidate will possess:

• Excellent clinical judgment and capability to analyze data from several sources is required.
• Ability to assess scientific issues, set up analysis processes and communicate in a scientifically sound and understandable way.
• Excellent computing skills.
• Expertise in database search strategy, including coding systems and data retrieval.
• Excellent teamwork and interpersonal skills.

Basic Qualifications:

• M.D. Degree is required.
• Minimum 5 years total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience and experience in clinical analysis of ICSRs and aggregate safety data.

Preferred Qualifications:

• Experience with safety databases use and analysis.
• Use of signal detection tools and basic knowledge of data mining methods.

Medical Director - Patient Centered Solutions (PCS) - Global Immuno & Inflammation Unit

Dual Reporting to Commercial/Marketing lead for the Global Immuno & Inflammation Unit and Medical Affairs Head of the Division

Develop and ensure execution of the Global Medical Affairs Strategy in line with the Brand Strategy supporting development and preparation of the launch for an anti-interleukin 4 in the fields of atopic dermatitis and asthma in partnership with Regeneron.

Responsibilities:

• Provide strategic input for the elaboration of the global brand plan by being the center of scientific expertise, and develops a medical affairs plan to support the brand strategy

o Develop and implement a strong advocacy plan with experts in the field, academics and professionals and/or patient associations. (Prior knowledge of and established relationships with key opinion leaders in the field of asthma and/or atopic dermatitis consider an asset)

§ Develop a strong advocacy program and organize ad boards or roundtables during major congresses to build product awareness for anti-IL-4 in asthma and atopic dermatitis and gain strategic insights for marketing and development strategy

o Prepare and implement a publication plan to support the development of the anti-interleukin 4 in both therapeutic areas( asthma and dermatology) according to the brand strategy and key messages defined

o Put in place a system of Competitive intelligence and monitoring of publications

o Develop a training program on the disease and competitors and ensure continuous update so as to assure optimal onboarding of team and of affiliate medical and marketing personal

o Lead the development and alignment of product life cycle management strategy and tactics to define and prioritize the future most attractive areas of for clinical trial investment

o Ensure the scientific integrity of sponsored and supported research, information, and relationships with healthcare providers and patient advocacy groups

o Ensure a patient-centric approach to development of medical strategy both for product and device development as well as possible services which can enhance the value proposition of the product; Provide relevant feedback to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials

o Coordinate the network of affiliate Medical Directors through regular contacts and meetings

o Ensure medical budget management

Basic Qualifications:

• Must have an MD qualification, with speciality in either dermatology or allergy or pulmonology or competencies acquired by previous experience in either therapeutic area
• Minimum of five years' Pharmaceutical/Biopharmaceutical experience in Medical Affairs and/or Research and Development

Preferred Qualifications:

• Able to work on projects in coordination with alliance partner
• Excellent communication and presentation skills with the ability to present scientific data in a credible manner
• Demonstrated track record of building and maintaining a KOL network in previous experience
• Strong track record in developing and executing medical strategy for key markets
• Strong understanding of the pharmaceutical business
• Experience working within an international company with a complex organizational environment and the ability to operate in a matrix team oriented structure
• Experience in working across and building effective partnerships between Marketing, Medical, Market Access, Research and Development and Regulatory.
• Continuous performance improvement across all our processes, systems & activities

Medical Director - Patient Centered Solutions (PCS) - Global Immuno & Inflammation Unit

Dual Reporting to Commercial/Marketing lead for the Global Immuno & Inflammation Unit and Medical Affairs Head of the Division

Mission:

Develop and ensure execution of the Global Medical Affairs Strategy in line with the Brand Strategy supporting development and preparation of the launch for an anti-interleukin 6 in the fields Rheumatology and Rheumatoid Arthritis in partnership with Regeneron.

Responsibilities:

• Provide strategic input for the elaboration of the global brand plan by being the center of scientific expertise, and develops a medical affairs plan to support the brand strategy

o Develop and implement a strong advocacy plan with experts in the field, academics and professionals and/or patient associations. (Prior knowledge of and established relationships with key opinion leaders in the field of asthma and/or atopic dermatitis consider an asset)

§ Develop a strong advocacy program and organize ad boards or roundtables during major congresses to build product awareness for anti-IL-6 in Rheumatology and Rheumatoid Arthritis and gain strategic insights for marketing and development strategy

o Prepare and implement a publication plan to support the development of the anti-interleukin 6 in Rheumatology and Rheumatoid Arthritis according to the brand strategy and key messages defined

o Put in place a system of Competitive intelligence and monitoring of publications

o Develop a training program on the disease and competitors and ensure continuous update so as to assure optimal onboarding of team and of affiliate medical and marketing personal

o Lead the development and alignment of product life cycle management strategy and tactics to define and prioritize the future most attractive areas of for clinical trial investment

o Ensure the scientific integrity of sponsored and supported research, information, and relationships with healthcare providers and patient advocacy groups

o Ensure a patient-centric approach to development of medical strategy both for product and device development as well as possible services which can enhance the value proposition of the product; Provide relevant feedback to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials

o Coordinate the network of affiliate Medical Directors through regular contacts and meetings

o Ensure medical budget management

Basic Qualifications:

• Must have an MD qualification, with speciality in either dermatology or allergy or pulmonology or competencies acquired by previous experience in either therapeutic area
• Minimum of five years' Pharmaceutical/Biopharmaceutical experience in Medical Affairs and/or Research and Development

Preferred Qualifications:

• Able to work on projects in coordination with alliance partner
• Excellent communication and presentation skills with the ability to present scientific data in a credible manner
• Demonstrated track record of building and maintaining a KOL network in previous experience
• Strong track record in developing and executing medical strategy for key markets
• Strong understanding of the pharmaceutical business
• Experience working within an international company with a complex organizational environment and the ability to operate in a matrix team oriented structure
• Experience in working across and building effective partnerships between Marketing, Medical, Market Access, Research and Development and Regulatory.
• Continuous performance improvement across all our processes, systems & activities

Medical Director - Patient Centered Solutions (PCS) - Global Immuno & Inflammation Unit

Dual Reporting to Commercial/Marketing lead for the Global Immuno & Inflammation Unit and Medical Affairs Head of the Division

Mission:

Develop and ensure execution of the Global Medical Affairs Strategy in line with the Brand Strategy supporting development and preparation of the launch for an anti-interleukin 6 in the fields Rheumatology and Rheumatoid Arthritis in partnership with Regeneron.

Responsibilities:

• Provide strategic input for the elaboration of the global brand plan by being the center of scientific expertise, and develops a medical affairs plan to support the brand strategy

o Develop and implement a strong advocacy plan with experts in the field, academics and professionals and/or patient associations. (Prior knowledge of and established relationships with key opinion leaders in the field of asthma and/or atopic dermatitis consider an asset)

§ Develop a strong advocacy program and organize ad boards or roundtables during major congresses to build product awareness for anti-IL-6 in Rheumatology and Rheumatoid Arthritis and gain strategic insights for marketing and development strategy

o Prepare and implement a publication plan to support the development of the anti-interleukin 6 in Rheumatology and Rheumatoid Arthritis according to the brand strategy and key messages defined

o Put in place a system of Competitive intelligence and monitoring of publications

o Develop a training program on the disease and competitors and ensure continuous update so as to assure optimal onboarding of team and of affiliate medical and marketing personal

o Lead the development and alignment of product life cycle management strategy and tactics to define and prioritize the future most attractive areas of for clinical trial investment

o Ensure the scientific integrity of sponsored and supported research, information, and relationships with healthcare providers and patient advocacy groups

o Ensure a patient-centric approach to development of medical strategy both for product and device development as well as possible services which can enhance the value proposition of the product; Provide relevant feedback to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials

o Coordinate the network of affiliate Medical Directors through regular contacts and meetings

o Ensure medical budget management

Basic Qualifications:

• Must have an MD qualification, with speciality in either dermatology or allergy or pulmonology or competencies acquired by previous experience in either therapeutic area
• Minimum of five years' Pharmaceutical/Biopharmaceutical experience in Medical Affairs and/or Research and Development

Preferred Qualifications:

• Able to work on projects in coordination with alliance partner
• Excellent communication and presentation skills with the ability to present scientific data in a credible manner
• Demonstrated track record of building and maintaining a KOL network in previous experience
• Strong track record in developing and executing medical strategy for key markets
• Strong understanding of the pharmaceutical business
• Experience working within an international company with a complex organizational environment and the ability to operate in a matrix team oriented structure
• Experience in working across and building effective partnerships between Marketing, Medical, Market Access, Research and Development and Regulatory.
• Continuous performance improvement across all our processes, systems & activities

• Assists with the development of and challenging project timelines to ensure stretch/realistic targets.
• Drives project and action item completion and ensures that activities represent value added deliverables
• Performs project risk analyses, suggests mitigation strategies, and monitors response options
• Provides management oversight of the budget process, by identifying variances and working with teams to off-set overspend and/or identify opportunities to execute with any budget favorability
• Ensures consistency of the medical affairs processes across the organization
• Ensures alignment of the strategy throughout the organization.
• Analyzes resource needs and recommends FTE allocation

Basic Qualifications:

The successful candidate will be a physician with 10 + years' experience in Medical Affairs which includes at least 3 years of managing direct reports. This experience should include commercialization of innovative and successful therapies.

Preferred Qualifications:

Experience in clinical development would be a plus. A strong background in MS or Immunology is preferred.

Leadership/interpersonal skills:

People leadership of a team of greater than 50 professionals will be a key component of this role. Strong leadership skills are a must to attract talent, motivate and maintain a high functioning organization as well as to provide individual development for all members of his/her organization. This position calls for an individual with high energy and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives. Strong communication skills and an ability to articulate a vision and mission and inspire his/her team on an ongoing basis are required. The VP should be comfortable operating in a consensus building role but also able to make critical decisions and drive these decisions through the organization. Possessing strong analytical skills, he/she must also be able to make critical decisions but must also be comfortable managing through ambiguity. The ability to comfortably lead teams through an environment of continual change is crucial to success.

Internally as well as externally, he/she must be seen as a leader. He/she should lead by example and model collaborative behavior and all other behaviors aligned with the Genzyme culture. Success in this role will be based on at least meeting, and preferably succeeding on both "the what" and "the how" in achieving objectives. He/she should be dynamic and visionary, and able to define clear and specific objectives, tasks and responsibilities.

Communication skills:

This role requires a strong communicator who can build solid working relationships with the commercial organization including the managed markets team, as well as negotiate and influence across cultures.

Travel requirements: 25%

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

QC/QA Head - Global Patient Safety

Position Description:

• Manage the group of Quality & Process specialists in GPE
• Oversee the development and implementation of the yearly quality program for GPE. Provides oversight for the development, implementation and maintenance of a quality system in Sanofi GPE which allows activities and delivery of Pharmacovigilance outputs with quality appropriate to meet the needs of ALL global regulatory authorities and other internal and external customers to ensure that Sanofi is a leader in the industry.
• Creates, enables and maintains a system which mandates for all Sanofi worldwide a state of control on monitoring and tracking control systems (quality assessment) with regards to all pharmacovigilance activities regardless of where they are performed in the company for process performance, process compliance and content quality, and providing assurance of continued suitability and capability of processes/system.
• Ensure that all issues are investigated according to GCPs and company policy and that all propose corrective action plan activities (CAPA) occur on time; participate in CAPA implementation.
• Directs and oversee the systems that ensure monitoring activities to measure effectiveness.
• Accountable for reporting to QTC management on the accuracy, quality and integrity of activities and processes assessed within GPE and the global PV network according to the quality program
• Contributes to the establishment & oversight of the GPE Quality continuous improvement and Operational Excellence programs ensuring that there is a validated corporate system to track the implementation of these programs ensuring that methodological support is provided
• Participate in inspection readiness activities.

Basic Qualifications:

• Minimum experience 7 to 10 years in International Pharmacovigilance activities including case processing, involvement in interaction with affiliates, training users and Health Authority interactions during regulatory inspection.
• Certified health professional degree required: example Pharmacist or Pharm D or Bachelor of nursing degree.
• Understanding of Pharmacovigilance processes, PV database system, Dictionaries required.
• Quality management: QA, audit, corrective action plan (CAPA methodology) definition and implementation
• Demonstrated knowledge of international regulations and guidelines ICH, CIOMS, EMEA/FDA

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Vice President Global Medical Affairs Rare Diseases

Job Purpose:

The Vice President, Medical Affairs Rare Diseases will build and manage a medical affairs group dedicated to supporting products across the Rare Diseases therapeutic areas. The Vice President, Medical Affairs will play a key role in the clinical and commercial development of Genzyme's rare disease products through strategic guidance and oversight of activities related to investigator sponsored trials, company sponsored non-registration trials, publications, and Key Thought Leader (KTL) outreach. Based on the affiliate insights and in coordination with the cross functional global team the VP will develop the global medical strategies for Rare Diseases. In addition, the VP will work closely with the leadership of Genzyme's Clinical Research and Commercial functions in the regions worldwide to support optimal life cycle management for all products. The primary goal of this position is to maximize patient benefit from Genzyme rare disease products based on key thought leader insights for strategic plans, development of the relevant data evidence and publications and knowledge development via Medical Education to support health system access.


Job Responsibilities:

Contribution of Medical insights for business plans in order to gain access into health care systems.

Development of medical strategies to provide relevant data evidence from company and Investigator Sponsored Studies (ISS) to ensure that the strategy is clearly defined and consistent with the clinical development and strategic objectives for each product, and that appropriate processes are in place for review, approval, management and support of studies while maintaining investigator independence. Oversee management of publication planning and execution to ensure that all data on Genzyme rare disease products generated by company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner

Oversee management of funding for CME, grants, and sponsorships to ensure that funds are allocated appropriately to activities consistent with the clinical development and commercial objectives of the business, and that review and approval processes are in place to maintain strict compliance with all federal regulations

Manage the regional medical officers in US, EU, LATAM and JAPAC. Provide guidance and strategic direction to Medical Affairs activities supporting rare diseases to the Genzyme affiliates worldwide.

Responsibility and accountability for the financial management and reporting requirements for medical affairs, including supporting the Finance reporting process with accurate and timely data and assumptions as needed to support budgeting, forecasting and long range planning for the business units.

Lead KTL engagement and knowledge development.

Ensure that medical guidance is pro-actively provided to marketing and sales teams

Contribute strategic guidance to relevant cross functional Product Teams. Provide expertise and ensure alignment of medical affairs with clinical development and commercial strategies / tactics with the objective to gain access into health care systems

Provide leadership identifying needs for post-marketing clinical trials and registries and oversee their management and execution

Represent the Genzyme Rare Diseases business units at medical meetings, advisory boards, outreach meetings at key institutions, and in interactions with KTLs

Represent Genzyme Rare Diseases business units at the corporate level and in interactions with other business units to optimize coordination and collaboration around areas of overlapping interests

Travels regularly (both internationally and within the US) as necessary

Board Certified M.D., preferably with experience in specialty medicines/ rare diseases

Extensive experience in medical affairs (10 + years) required

Management experience of a country affiliate medical team and a regional or global medical affairs team.

Preferred Qualifications:

Experience in clinical development, health economics or commercial functions desired.

Well established leadership skills

Demonstrated ability to work effectively in a matrix environment

Excellent communication skills, condensed business language, very good presenter in front of internal and external audiences

Customer oriented strategic thinker. Excellence in implementation

Proficient in public speaking