Shire Country Medical Lead, Ophthalmology in Toronto, Canada
The Country Medical Lead (CML) provides strategic alignment with Global and Country Medical Affairs (MA) plans. CML is accountable for the development and execution of the full scope of medical affairs activities related to assigned therapeutic area (TA) in the country/cluster: strategic planning and leadership, data generation, data dissemination, medical knowledge and insight management as well as medical community.
Ensures medical guidance and cross-functional collaboration (sales, marketing, VD&A ), e.g. medical/scientific training and launch planning and execution .
Maintains personal and medical team expertise in relevant disease areas and MA best practices.
Plans, oversees and may direct the work of a small team of Medical Advisor(s) and/or MSL(s).. Supervise, ensure training, coach and encourages optimum performance. Provides developmental opportunities in alignment with Global and Country MA goals.
% of Time
Job Function and Description
Medical Leadership and Strategic Planning
Collaborates with Country Medical Head and Global Medical Team to provide country input into Global Medical Brand Plans. Accountable for development and implementation of country medical plan for the respective TA. Uses key performance indicators and metrics to track progress against the activity plan
Plans and guides product launch activities and continuously evaluates product launches to ensure launch excellence
Cooperates cross-functionally and across TA, within established structures, and governance. Facilitates knowledge exchange, within established governance and communication processes (at internal meetings, Journal Clubs, virtual meetings). Contributes to medical training of field-based commercial personnel as assigned.
As relevant, provides input into department strategy (e.g. for assigned team / products), adjusts if required, sets team goals, and ensures execution.
Facilitates budget planning on TA level, reports and monitors execution of planned activities.
Assesses and reports resource needs, develops and provides TA performance feedback to team members.
Ensures activities are carried out in a compliant manner.
Ensures Adverse Event reporting.
Leads by example and serves as a role model to embed Shire culture and values.
Works with HR to recruit, interview, select and hire appropriate employees.
Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning opportunities.
Collaborates appropriately with KOLs and Investigators to identify areas of shared scientific interest and advances partnerships per guidance of the CMH and research areas of global focus.
Formulates relevant data gaps and escalates to CMH and GMA
Supports investigator-initiated research after unsolicited approach by KOLs by engaging with these potential investigators and guiding them through the Shire processes. Follows up in relation to contractual obligations and milestones
Supports the clinical operations organization upon request, by the study team, in conducting Shire sponsored clinical trials, e.g. site proposal, disease state education and answering specific questions from investigators
Cooperates with HEOR in planning and execution of research activities.
Leads identification of the scientific exchange needs of KOLs, investigators and other stakeholders in patient care, establishes strong professional relationships, and provides credible scientific expertise
Develops and executes best in class educational events for HCPs (accredited and non-accredited) in cooperation with KOL, GMA and Clinical Development
Provides scientific support in development of publications in accordance with GPP and Shire policies
Presents scientific data to HCPs in accordance with Industry Codes and Shire policies (1:1 or in groups). Participates in selected global and regional congresses, symposia, medical committees and reviews as guided by CMH and GMA
Maintains awareness of and access to internal and external information sources available to support best-in-class scientific exchange, and coordinates appropriate utilization of these resources by external customers
Responds effectively to requests for scientific exchange. Coordinates response within defined timeline and quality standards to unsolicited inquiries from HCPs and other stakeholders as per Shire SOP
Presents to payers and supports development of experts reports as requested by VD&A team, depending on specific country needs
KOL Engagement and Planning
Engages with external stakeholders (e.g. KOLs, HCP, administrators) as appropriate and in line with applicable Shire and Industry policies. Develop and maintain “peer-to-peer” scientific relationships with key thought leaders in healthcare, academia and government organizations
Defines KOL list of the relevant top national/international KOL and develop and execute engagement plans in accordance with their scientific and professional interests
Maintains KOL plans and timely, accurately and compliantly updates medical customer relationship management system
Dedicates at least 35% of the work time to field-based activities devoted to external partnerships and collaborations
Knowledge, Expertise and Insights Management
Maintains and shares scientific and medical expertise/ findings on relevant disease areas, therapy advances, products and current research, and competitors
In coordination with Country Medical Head and Global Medical Training, trains medical science liaison team and other relevant colleagues on fundamental disease area knowledge and emerging evidence
Leads the strategic planning and execution of advisory board meetings. Actively participates in advisory board and clinical investigator meetings per TA requests.
Consolidates, interprets and shares with GMA local intelligence obtained in 1:1 conversations, advisory board meetings, literature, conferences etc.
Develops and updates knowledge of applicable pharmaceutical guidelines and regulations, including ICH, GCP, Rx&D Code of Ethical Practices and company policies
Develops and maintains proficiency in specific MA areas (e.g. Evidence Based Medicine, Real World Evidence, Impactful Communications etc.)
Attends and reports on relevant regional, national and international scientific and patient advocacy meetings as assigned
Education and Experience Requirements
A medical or advanced science degree (MD, PharmD, PhD or equivalent is required)
4-6 years of experience in biopharmaceutical medicine, specifically in medical and scientific roles, is required e.g. at the brand or disease area levels
Experience in people management is required
Experience in 2 of the following criteria is required
Medical affairs roles
Designing and leading clinical or research studies
Assigned disease areas
Key Skills, Abilities, and Competencies
This job requires skills in leadership, analytical thinking, interpersonal relationships, focused planning, oral and written communication, and effective collaboration. The candidate will exhibit the ability to think critically, innovatively and strategically, manage oneself effectively in a fast paced, challenging environment, and remain focused on achieving team objectives. This job also requires the ability to develop and maintain strong strategic alliances with key opinion leaders, business partners, and colleagues in a professional manner.
The incumbent must possess interpersonal skills and demonstrated ability to manage conflict situations as well as record of responsible actions. Must also have excellent English and local language, verbal/written communication skills, excellent presentation and teaching skills, computer literate, and able to contribute to cross-functional teams. Ability to influence, initiate, and accept change, and address complex, multi-faceted questions and issues. Demonstrates exceptional follow-through with respect to tasks and projects.
Valid driving license.
Complexity and Problem Solving
Reports to the CMH and aligns strategically to country MA plan and TA GMA plan
Responsible for a complex TA with multiple brands (e.g. IM, GD)
Ability to manage in complex healthcare systems (e.g. multiple regions) and non-traditional stakeholder environments (e.g. HTA, administrators)
Expected business acumen and cross-functional cooperation – to understand the needs and to be able to guide the strategy
People management – MSL, MA
Internal and External Contacts
Position is accountable to the Country Medical Head
Internal Collaboration: Compliance, Legal, Country HR, Country Commercial, Global Medical, Global Clinical, HEOR, VDA
External: Key opinion leaders, investigators, HCPs, patient advocacy groups, regional policy makers, etc.
Other Job Requirements
Potential travel to International HQ, local and international congresses and in-country meetings
Overnight stays and work on weekend is expected
Frequent travel to HCP locations – approximately 35% of time in field
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.