Jul 15, 2019
To support the General Manager and lead the Asia Medical Team in providing strategic medical input into all relevant areas at CSL Behring including Medical Affairs, Clinical Research, Regulatory
Affairs, Pharmacovigilance, Quality, Sales and Marketing, Public Affairs and Market Access.
To engage and build strong links with key external medical experts in all therapeutic areas of
involvement by CSL. To lead in communicating and discussing both the depth of science behind CSL’s medicines and develop strategic partnerships to facilitate the quality use of our medicines.
To develop and maintain an in-depth understanding of the therapeutic areas of relevance to the Asia Team business.
Role that this position reports to: General Manager, ComOps Asia and dotted line to Senior Director, Medical Affairs, Asia Pacific
Roles that report to this position may include: Medical Science Liason, Senior Medical Product Specialist, Medical Product Specialist, Associate Medical Product Specialist, Medical information Manager, Medical Information Officer
This position can be delegated to: Medical Manager/Senior Medical Manager
Main Responsibilities and Accountabilities:
1. Ensuring actions comply with:
Relevant country regulation, policy and Code of Practice
CSL’s Code of Responsible Business Practice
Interactions with Healthcare Professionals and Healthcare Organizations (POL-0013)
Anti-Bribery and Anti-Corruption (POL-0400)
Global Process to Handle Questions from External Healthcare Professionals “Global Q&A Process” Working Instructions Document
Records Management Policy (POL-0133)
CSL Global ClinCom Guidelines
MSL practice guideline
Provision of medical and clinical leadership in product launches, issues management and recall situations.
Develop expertise in all medical areas relevant to designated CSL Behring products including analysis of current literature, opinion and recommendations.
Work collaboratively and proactively with the Brand Teams at a Local, Regional and Global level to develop strategic medical, scientific and relationship management plans that align with business objectives.
Work with marketing and other relevant staff at a Local, Regional and Global to develop marketing strategies and supporting materials for designated products in local markets
Medical input into key cross-functional groups( including, but not limited to): Marketing; Regulatory; Pharmacovigilance; Clinical R&D, Market Access, Manufacturing and Quality for successful development and life cycle management of products
Key member of the new product introduction process. Responsible for leading medical activities required for this process.
Develop programs and activities appropriate to launch designated products, including training materials, standard responses (inc. medical information), product monographs, data updates, representative memos and other materials as required.
Contributing to the education and training of relevant CSL staff, including sales representatives, marketing, medical, clinical research and regulatory affairs staff.
Provide guidance to the Pharmacovigilance group including medical evaluation of adverse events arising from both clinical research and post market reports/studies, medical review of periodic safety update reports and provide medical advice for signal detection and management activities( where deemed necessary).
Contribute to internal Safety Management Teams. Provide medical review to Product Risk Management Plans and contribute to the planning and implementation of pharmacovigilance and risk management strategies.
4. Interaction with Medical and Scientific Community
Provide a high quality single point of contact for scientific interaction between external experts / HCP’s and CSL Behring;
Interact responsibly and provides leadership within governance and compliance guidelines( and/or relevant Country Codes) with targeted health care professionals, professional associations and other key stakeholders;
Provision of medical and clinical expertise to submissions and presentations to local and global government authorities, where relevant, to achieve Government advocacy and funding of CSL Behring products.
Respond to requests for scientific and medical information in a comprehensive, timely and customer focused manner;
Actively drive Scientific Advisory Board meetings to ensure knowledge transfer, foster External Expert (EE) relationships, ensure scientific understanding and build appropriate advocacy;
Actively participate in Scientific and Medical symposia. Assisting with development of CSL Behring sponsored programs;
Act as spokesperson for medical matters and be a key advocate for CSL Behring products in a range of circumstances e.g. Advisory Boards, seminars, conferences etc.
Be a medical/scientific interface with key stakeholders in dealing with product related issues.
Ensure development plans are initiated and actively managed via mentoring and on the job coaching for all direct reports including MSLs;
5. External Expert Development
Ensure development plans are initiated and actively managed for identified EE’s;
Facilitate speaker development and involvement locally and internationally;
Ensure appropriate EE development through participation in clinical trials;
Ensure communications are tracked in appropriate systems to ensure CSL Behring is compliant with good governance and transparency regulations.
6. Therapeutic Area Expertise
Develop and maintain extensive knowledge and competency of the immunology, hemophilia and acquired bleeding therapeutic areas, pipeline and the competitive landscape;
Be considered a field-based expert by internal & external customers; and
Disseminate knowledge and share information as appropriate( within compliance regulations), through internal and external presentations;
Facilitate training and education of relevant stakeholders.
Ability to be a part of the review and approval process for materials (as required).
7. Data Generation and Research Strategy
Leads, organize and control data generation projects within the areas of responsibility for local Team projects. Liase with Regional and Global Team to collaborate and drive execution of local data needs.
Understand data generation and requirements that are needed to facilitate the development of business solutions.
Assist with publication planning and presentations of data at medical & scientific meetings.
May be required on occasion to act as designated medical monitor to CSL sponsored studies (when requested).
Provide medical review and contribute to clinical trial protocols and investigator’s brochures as well as the medical sections of core product information as required.
Provide medical review and contribute to clinical study reports, expert reports, safety update reports, and manuscripts for external publication as required.
Co-ordinate and lead the review of Investigator Initiated Studies (IIS). Provide medical insights to the assessment and implementation of IIS.
Facilitate site feasibility assessments of CSL sponsored studies (where required).
8. Key Relationships (both internal and external)
Internal: Medical Director, Clinical Safety, Regulatory Affairs, Clinical Research, Sales & Marketing Director and team, Director of Public Affairs, CSL Behring ealth Economic Team, Business Development, CSL Behring Medical team, Research and Development, Quality and Manufacturing.
External: Blood Service Authorities, Government departments, External Experts, Scientists, Clinicians and Nurses, Country specific Governance and Compliance Codes and/or country specific Advertising Code Regulators, Regulatory Authorities and Funding Bodies.
Tertiary qualifications in a relevant discipline such as pharmacology, pharmacy, immunology, biosciences, public health or epidemiology. PhD in a relevant scientific field would be highly desirable.
At least 7 years of appropriate experience with demonstrated relevant competencies required to qualify for this role.
Prior Pharmaceutical or Biotech industry experience (medical, clinical or specialty products expertise)
Ability to apply and leverage scientific and medical knowledge is essential
Experience in therapy area is desirable
Strong negotiation, influencing and leadership skills
Excellent presentation, interpersonal and communication skills
Demonstrated ability to manage relationships with external experts
Demonstrated business planning ability and strong organisational skills
Demonstrated innovative thinking
Demonstrated working knowledge of regulations governing information
provision/interactions with customers within the pharmaceutical industry.
Strong medical governance capabilities.
Strong strategic thinking capabilities
Ability to work independently & be self-motivating
Good relationship builder and communicator
High ethical standards as well as personal credibility
Creating Business Solutions
Strong ability to interpret scientific data
Able to bridge and balance medical insights with business solutions
The role will station in Singapore and provide medical leadership to the Asia Region. Offsite attendance at meetings, conferences, exhibitions is required, which includes interstate and international travel (approximately 40%). This position description provides a summary of key features of the role. It may be varied as necessary by the Company from time to time.
CSL BEHRING PTE. LTD.