The Medical Director (Head Medical Affairs) is accountable for defining the strategic alignment and execution of medical affairs activities related to investigator and expert outreach, investigator sponsored trials, company sponsored non-registration trials, publication planning, CME, grants, related to assigned TA products, including:
Cultivating current and future experts in academic and clinical medicine at regional and national levels. Through these relationships, the Medical Director will gain meaningful expert insights that influence priority areas of the product Life Cycle Planning team in support of business, clinical and scientific strategy
Representing Sanofi Genzyme at related medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with thought leaders
Managing the field regional medical advisors (MSL). Together with the RMA team, provide updated clinical data in response to unsolicited HCPs and provide relevant strategic disease state education.
KEY RESULTS/ACCOUNTABILITIES
Job Description
Medical affairs leadership
Lead and develop a high calibre Medical Affairs Team for establishing a culture of collaboration, networking and immediacy of support within the team to ensure efficient and dynamic ways of working within the GBU and with other relevant internal colleagues eg compliance, regulatory and PV.
Offer leadership to the Medical Affairs Team to ensure high quality delivery of medical affairs activities to internal and external customers. Ensure the team is educated on TA diseases, the competitive landscape and the company’s products and has the tools and resources to provide relevant updates and responses to unsolicited requests. Oversee implementation of medical tactics and scientific programs.
Ensures proactive and high quality input by the Medical Affairs Team into Brand Plans and Strategic Plans to ensure efforts are coordinated and aligned.
Lead by example through setting and monitoring robust objectives and establishing personal development plans
Bring to life a proactive development and retention strategy for staff within the scope of the company career and talent development policy.
Serves as the medical representative on the TA Canadian Leadership Team and as the Canadian representative on the North American TA Medical Affairs Leadership Team
Lead the local evidence generation strategy, plan and execution
Lead the gap analysis and development of innovative approaches to the evidence generation and clinical plans to meet the needs of the local and global BU including new study designs and alternative methodologies.
Support the implementation of clinical programs.
External Interactions
Maintains proactive and broad relationships with key contacts in the Canadian healthcare environment (eg KOLs, clinics, related groups) as part of a co-ordinated stakeholder plan in order to secure involvement in stakeholder discussions and position Sanofi Genzyme within key healthcare initiatives.
Represent Sanofi Genzyme in clinical interactions with senior external stakeholders such as HCPs and patients.
Internal Interactions
Provide medical support, education and guidance to the TA franchise strictly following corporate compliance guidelines. Ensure appropriate resource (eg signatories, technical check) is in place, co-ordinated and developed within the medical affairs team to complete the required review and approval of promotional and non-promotional activities as required
Provide medical input as for advisory boards and other scientific programs in line with global and local policies and procedures.
Support the Medical Information service with relevant medical expertise for the TA Franchise in relation to defined prescription medicines in order that customer queries, internal and external, can be answered accurately and promptly.
Develop relationships with internal key contacts (other affiliates, Region, Global, International Medical Affairs and R&D) in order to share best practice; take part in cross-functional transformation programmes; obtain acceptance of and approval of Canadian projects; and influence global Sanofi Genzyme medical strategy.
Support the medical review of suspected adverse reaction reports associated with prescription medicines in conjunction with the Pharmacovigilance function, enabling PV to report appropriately to the regulatory agencies and Corporate PV so that prevailing legal and Corporate requirements are met.
Provide medical opinion to Regulatory Affairs so that regulatory strategies can be developed.
Maintain knowledge of TA market place, stay current on leading edge products development efforts and provide perspective to the business on the treatment landscape.
Management of Resources
Adheres to company-defined processes for the selection of and agreement of commercial terms with vendors
Understands and uses internal procedures and tools to ensure the compliant and efficient operation of the “Purchase to Pay” process.
People Leadership
Performance manages the team through setting and reviewing priorities. Provides appropriate and timely feedback about performance and coaches team members to help them achieve their goals
Supports the professional and career development of the team by identifying the skills and competencies that employees need for their current and prospective roles and provide opportunities to learn and practice new skills
Leads the building of a motivated and engaged team through the use of formal and informal recognition, regular communications and the encouragement of cooperation between individuals and teams
Holds individuals and teams accountable for their performance & promotes the culture of high performance within Medical Affairs.
Ethical Leadership
Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (including the Industry Code of Practice, Sanofi Policies and Procedures and any relevant legal requirements); and demonstrate personal leadership in applying these to all work undertaken.
Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role.
Environmental and Safety Leadership
To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work. Employees are therefore expected to: -
Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment; Serves as the management representative of the site/local Health & Safety Committee
KEY WORKING RELATIONSHIPS
INTERNAL
Regular, close contact with:
Therapeutic Area Franchise Head & Commercial Team
GBU Medical Committee Chair and other GBU TA Medical Directors
TA NA Medical Head
CSU, PV, QA teams
Regulatory team
PSP team
Regional Sales Directors
Market Access
PA/Public Affairs Leads
Communications team
Occasional contact with:
Financial Controller
Program Manager
Only as needed:
Legal
Other Business Support Functions
EXTERNAL
Primary point of contact for:
HCPs
Would be expected to be involved with:
Research establishments and organisations
Professional and Learned societies
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
Senior physician having successfully performed the function of Director of Medical Affairs and having solid medical and scientific expertiseand in the current scientific environment
6-10 years plus pharmaceutical industry experience covering the leadership of a broad set of medical activities including clinical trials, medical affairs, compliance and external engagement
TA experience preferred
Trained Medical Practitioner; board certified/eligible
Specialist accreditation and/or other professional certification is desired
Higher Medical Qualification (Normally Membership or Fellowship of a Medical Royal College or Faculty) is desired
Experience of setting, balancing and managing a budget to target
Ability to lead, manage and develop teams.
Detailed knowledge of Food & Drug Act regulations and guidelines, industry codes of practice/standards and standard operating procedures, and experience of their implementation within the business environment
Principles and practice of medical affairs including clinical trial design, management, analysis and reporting, including GCP
Knowledge TA therapeutic area, including solid relationships with key opinion leaders preferred
Knowledge of the structure and management of the Canadian health system
Excellent command of English both written and oral and good IT skills; French language is an asset
COMPETENCY REQUIREMENTS
LEVEL
Act for change
Strive for results
Co-operate transversally
Commit to customers
Think Strategically
Leads teams
Develop people
Makes Decisions
Leading others through business area management
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