Country Medical Director

The Position
Responsibilities
* Establish and maintain local medical and scientific independence and assurance of medical compliance acting as the local delegate of authority of Roches Pharma CMO ensuring business integrity and company reputation
* Represent Roches scientific positions among key external stakeholders (eg. scientific partnerships, governmental affairs, media interactions, etc); PAGs; other pharma companies (individual or association) and forms strategic partnerships
* Member of affiliate leadership/enabling team acting as the architect, catalyst and coach of medical and scientific expertise, of decisions driven by science and data, of professional cooperation with HCPs and other external stakeholders, of patient centricity and of professional behavior driven by the ambition to deliver better treatment to more patients faster
* Act as local integrator of development and license to operate functions namely safety, regulatory, quality, (if applicable biometrics) and clinical operations irrespective of their reporting lines to ensure that development functions work coherently and integratively across and with other local functions, encourage development functions to align as appropriate with global functions, and enable the organization to serve local needs and to cover local accountabilities in line with rules and regulations
* Work closely with local, cross-country and global compliance network, strong cross-functional partnership with other affiliate (and network) functions and actively engaging with Roche global functions and group members
* Be a servant leader to the entire affiliate and network acting with courage and integrity. Role model creative leadership and network mindset supporting transparency across the organization. Act as a leader following the VACC principles:
* Visionary: Articulates a bold, shared vision that is centered on the patient, embeds and projects this vision in all internal & external interactions
* Architect: Builds empowered and scientifically sound medical teams who are enabling Primary Point of Contacts (PPOCs) and are capable to make impactful and company and portfolio differentiating decisions
* Coach: Helps everyone in the affiliate and the PI network to build the skills and the mindset they need to learn, grow and succeed
* Catalyst: Removes obstacles and creates framing, clarity and focus
* Engage as an active network player to shape company strategies, structures, processes and behaviors
* Catalyze and coach innovative solutions along the patient journey with a strong focus on digitalization and personalized healthcare in the context of our pioneering medicine portfolio, digital health and integrated solutions with a OneRoche lens enabling access to the right diagnosis and the right treatment for the right patient
* Enabler, partner and co-creator for the local and global integrated strategy (as appropriate contribute to IDCP, IEP, ISP). Catalyze appropriate medical and scientific contribution to the development and execution of the agreed local strategies and tactics
* Role modeling the external focus and engaging with external healthcare stakeholders to enable health equity and healthcare sustainability by shaping the environment and ensuring sustainable access to innovation
* Catalyze the capability development of relevant stakeholders in the ecosystem (e.g. helping start-ups grow, activating Patient Groups (PAGs), etc.)
* Architect, catalyze and coach effective interfaces between medical enablers, safety, quality, regulatory functions and PPoC roles to enable fit-for purpose integrated customer-centric solutions with adherence to the highest ethical, compliance and quality standards
* Inspire high levels of medical expertise and a scientific mindset across the affiliate and instills enabling mindset throughout the medical team and the affiliate
* Accountable for the appropriate approval of non-promotional and promotional materials ensuring compliance with applicable local and global requirements
* Oversight of sufficient and appropriate resourcing (local and from the network), appropriate qualification and adherence to mandatory training curriculums while architecting and catalyse opportunities for constant talent fluidity, learning and growth
Evidence Generation / Cooperation in Medical Affairs Network (RWE, NIS,
IIS, interventional Roche sponsored; local, cross-country and global trials,
etc.)
* Accountable for clinical data generation portfolio needed to fill evidence gaps and anticipate/support patient access according to the local needs and in line with global strategy. This includes both local projects or local contributions to network (cross-country) and global data generation activities
* Drive a systematic approach at the appropriate time during drug development in co-creation with the PI and PDMA network to identify, prioritize and address evidence gaps aiming for faster and broader access to medicines with a portfolio wide view to allow trade-off decisions
* Ensure the highest standards of clinical trial conduct, disclosure and data
* transparency
* Ensure that Roche is known as a professional and reliable partner for cooperation on evidence generation while highest transparency and compliance of this partnership is ensured
PDG collaboration in PDG Network Countries and Medical Affairs Network
Countries
* Work closely with clinical operations in the respective PDG or Medical Affairs country network to enhance clinical development capabilities to foster an effective and sustainable research environment that allows for innovation and stronger external partnership
* Foster a collaborative network between medical and clinical operations teams, enabling the work in a fluid structure that capitalizes on the strengths and capabilities of each individual, and leverages a robust and integrated strategy to deliver assets from clinical programs to clinical practice
* Ensure adherence and implementation of all projects in compliance with regulatory requirements (ICH-GCP), good pharmacovigilance practices (GVP), local legislations and Roche governances and procedures, in collaboration with clinical operations
Medical Information (MI)
* Ensure medical and product information provided in compliance with SOPs, local requirements and that all data used in the provision of MI are accurate and meet the needs of internal and external customers. Facilitates a customer centric approach and seeks opportunities to increase the value of medical information service
* Funnel information and insights received via MI back to product teams
Patient Safety
* Catalyze and coach a Pharmacovigilance (PV) compliance culture where 'accountability follows ownership' to ensure local activities are conducted in accordance with global and local regulatory requirements and processes within the line management responsibility (i.e., within the teams reporting to the CMD)
* Catalyze and coach the products are brought to patients in line with PV compliance standards demanded by fast-changing landscape (e.g. digital, software as medical device)
* Catalyze and coach patient safety activities to transform clinical practice and support patients (safety business partnership), both in terms of communication and evidence generation, across the full portfolio of Roche products
* Proactively ensures conduct of assessments and management of safety risks related to local clinical practice
Regulatory
* Architect, catalyze and coach effective relationships with regulatory, reimbursement and other health authorities to shape the regulatory environment
* Catalyze and coach innovative regulatory assessments and effective regulatory strategies to ensure early registration and access to innovation
* Preserve the license to operate for existing product portfolio and regulated digital health and software as medical device applications
Quality
* Facilitate a Quality Management System to guarantee the quality of Roche medicines, including compliance with applicable local and global requirements
* Catalyze, coach and mentor continuous quality and process improvements, driven by patient centricity and the pursuit of customer satisfaction
* Communicate the value of Quality externally, when and where appropriate
Health Economics / Market Access
* Anticipate clinical/RWD data needed to accelerate patient access and include as appropriate in the IEP
* Ensure clinical value evidence and medical contribution are provided to support Health-Technology Assessment submissions
* Act as an ambassador for Value-Based HealthCare and Personalized HealthCare, going beyond the medical/scientific aspects, as a means to build sustainable HealthCare systems that put the patient in the center, taking a long-term perspective to engage on strategic issues and scanning for trends / issues
* Contribute to the identification of above-Therapeutic Area Health Care policy issues and collaborates internally & externally (e.g. PAGs) to address them
* Enable and provide advice on Regulatory, Drug Safety, Health Economics and Health Policy strategies with medical expertise and scientific data
Who You Are
Competencies
* Servant leader exemplifying VACC leadership, Roche Values, Roche Leadership Commitments and inclusive leadership behaviours
* System thinker with deep listening skills and growth mindset, able to learn and unlearn quickly while experimenting and taking smart risks.
* Entrepreneurial mindset and ability to support the organization to make portfolio wide trade-off decisions
* Enabler mindset leveraging internal and external networks to create and maximize value
* Highly strategic and customer centric, setting the tone for how networks deliver better outcomes to more patients faster
* Can manage high complexity balancing people development, competency building and external leadership
* Excellent oral and written communication skills, including the ability to articulate clear messages from complex data/ information
* Business and financial acumen
* Fluency in the English language, oral and written
Experience
* Solid understanding of pharmaceutical business with profound Medical Affairs experience
* Understanding of the local health care system, including regulatory and payer environment
* Good understanding of the disease areas set as a priority for the Company and of new molecules, personalized medicine and digital health
* Understanding of medical and strategic aspects of drug development stages; medical strategies including integrated evidence generation, knowledge sharing and scientific collaborations; medical compliance (GCP/GVP/GMP/GDP), Health Care Compliance and Quality Assurance Management
* Substantial experience of practicing clinical medicine (if MD) and clinical research is a plus Education
* Medical degree is required and mandatory in i8 countries. Board certification in a medical specialty is appreciated
* Only in i7 countries, if no qualified candidate with a medical degree can be identified after a targeted search, other HCPs (e.g. pharmacist) or human life science degree with the relevant experience might be considered, provided that other employees with a medical degree are accessible within the local medical department
Department: Medical Affairs
Reporting line: General Manager/Country Manager
Who we are
At Roche, more than ‎100,000 people across ‎100 countries are pushing back the
frontiers of healthcare. Working together, we've become one of the world's
leading research-focused healthcare groups. Our success is built on
innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.