• Lead development and maintenance of scientific strategies for Innovative Products in Santen’s FOTE/BOTE portfolio
• Conduct data analyses, identifying data gaps in Santen data and in the literature and formulate plans to fill data gaps
• Work with the publication lead to develop the publication and congress strategy for FOTE/BOTE products
• Conduct cross-functional data summits to further Santen’s understanding of clinical data and data in the literature
• Manage repositories of available Santen data, making data and study-related information accessible to the Global Medical Affairs team
• Design appropriate post-marketing studies for launched products
• Understand the level of scientific expertise across multiple departments and proactively provide audience-appropriate internal scientific education
• Facilitate advisory boards, identifying needs for external input, selecting appropriate advisors, and ensuring external input reaches all appropriate Santen stakeholders
• Support dossier development with scientific, editorial or other support
• Participate in regulatory filing teams
• Serve as a scientific subject matter expert on external podium presentations

Skills: Scientific Strategy Development, Data Analysis, Data Gap Identification, Publication Strategy, Cross-Functional Collaboration, Data Management, Post-Marketing Studies, Scientific Education

• Lead the Therapeutic Area Medical Team at the International Multidisciplinary Core Teams and take clinical development responsibility for the assigned projects.
• Accountable for the medical oversight of the clinical trial program during development, study conduct, analysis and reporting, as well as for the continuous benefit-risk assessment.
• Medical leadership in regulatory meetings and for the submission strategy, and contribute to the assessment of safety-related issues and to regulatory dossiers
• Chairperson or as part of the cross-functional Global Clinical Development Team/Medical Sub team and as a medical project representative at advisory boards, adjudication committees and at clinical trial data monitoring boards.
• Approve publications within projects, develop new business strategies and acquire new assets
• Review Committee responsible for assigned molecules in the portfolio
• Identify the need for studies to be conducted and provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary.
• Leading the global medical affairs activities
• Providing global leadership for all associated medical activities, 
• Managing and developing both existing and new medical activities to deliver commercial success 
• Develop and implement global plans to deliver the medical strategy

Skills: Medical Leadership, Clinical Development, Regulatory Strategy, Cross-Functional Collaboration, Publication Approval, Medical Affairs, Strategic Planning, Global Leadership

• Lead and develop the annual and long-range global medical plan for CX-8998.
• Lead and develop molecule data generation plans to support the Global Molecule Team (GMT) objectives.
• Work closely with GMA Clinical Scientists to develop Medical Affairs-led studies including the development of synopses, protocols and plans.
• Oversee the development of the disease and product scientific platform
• Craft a product medical communication strategy and work closely with the Medical Communications Team to develop a publication plan
• Work closely with the Medical Communications Team to develop core medical materials (e.g. product and disease training, pivotal studies slide decks) to be disseminated and adapted by the regions
• Engage with the Clinical Development Team to ensure important clinical evidence gaps are considered in the development program
• Work with the Commercial Development Team to develop plans and materials to ensure a successful product launch
• Serve as the single global voice of Medical Affairs at key matrix teams.
• Considered as a subject matter expert in the specific disease area and the molecule area.
• Maintain strong scientific knowledge of the relevant disease space and the competitive landscape

Skills: Medical Planning, Data Generation, Study Development, Scientific Platform, Communication Strategy, Medical Materials, Clinical Evidence, Product Launch

• Maintain an up-to-date knowledge of relevant emerging scientific and clinical data.
• Translating clinical research concepts of the new drug candidates into specific objectives to effectively achieve program goals.
• Providing medical expertise, discussion of disease and context of treatment for protocols, clinical study reports and other required documents
• Providing medical insights and training to internal and external partners
• Working cross-functionally and closely with Clinical Operations to ensure assessment of trial feasibility, proper investigator and site selections.
• Overseeing and managing the quality and consistency of work from CRO partners
• Participating in or conducting initial site selection.
• Attending weekly update meeting with core (study) team (PM, DM, CRO)
• Establish and maintain strong peer-to-peer relationships with key medical thought leaders in the fields of FOTE/BOTE
• Liaise closely with Biomedical Sciences and Biostatistics departments to ensure Global Medical Affairs has access to current and accurate data

Skills: Scientific Knowledge, Clinical Research, Medical Expertise, Internal Training, Cross-Functional Collaboration, Quality Management, Site Selection, Relationship Building

• Develop and execute a global medical affairs plan for the designated portfolio
• Align medical and access strategy for Vaccines of responsibility
• Ensure patient needs are at the centre of to access and market strategy
• Provide medical leadership to cross-functional projects
• Gather and incorporate local insights from key international territories into medical strategy and planning
• Lead the medical evidence generation plan
• Ensure all external communications are scientifically accurate and applicable to laws and regulations. 
• Provide rigorous scientific review of medical and promotional materials
• Generate audience-appropriate scientific and medical insights to cross-functional teams at various levels within the Santen organization
• Facilitate and continue to build Amgen’s role as a science-based, patient-focused partner
• Plan resources and budget allocation to deliver on medical strategies

Skills: Medical Planning, Access Strategy, Patient Focus, Leadership, Insight Gathering, Evidence Generation, Scientific Review, Resource Planning

• Develop and implement strategies to collect clinical data on the performance and safety of DORC products to support business growth and sustain regulatory compliance
• Develop and implement publication and communication strategies around medical and clinical matters, including review of marketing communication
• Advice company management on strategic topics that require medical and/or clinical input
• Contribute to innovation by providing insights into and requirements for medical and clinical matters
• Maintain a thorough and up-to-date knowledge of literature and developments in the market related to new technology, clinical outcomes, as well as patient safety and share any relevant information with key stakeholders
• Independently review and approve clinical and medical conclusions and assumptions related to risk management, clinical evaluations and other regulatory sensitive documentation
• Ensure that clinical and performance claims communicated through DORC-controlled channels are accurate and based on scientifically sound data
• Ensure that DORC complies with post-market obligations related to clinical evaluation and post-market clinical follow-up
• Represent DORC in discussions with regulators, KOLs or other stakeholders in relation to adverse events, clinical or medical affairs, or other relevant topics
• Lead, develop and manage a team of professionals
• Participate in and present at scientific/commercial events. 

Skills: Clinical Data, Publication Strategy, Strategic Advice, Innovation Insights, Literature Knowledge, Risk Management, Claims Accuracy, Post-Market Compliance

• Experience in Evidence Generation within or outside the pharmaceutical industry, including trial design, conduct, analysis, and reporting of clinical trials
• Experience with the launch of drugs/indications
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.
• Strong scientific background and proven ability to interpret scientific data and study.
• Extensive experience in clinical trial study design.
• Knowledge of injectable medical devices.
• Expert clinical development experience in an academic environment
• Clinical development experience in the pharmaceutical industry
• Experience in early development/translational

Qualifications: BA in Medicine with 9 years of Experience

• Experience in developing global occupational health strategies and policies
• Proficiency in Occupational Medicine experience
• Well-developed critical thinking skills, experience making fitness for duty decisions, and can demonstrate logical progression in decision-making
• Excellent social/interpersonal skills, functions well leading and working on a cross-functional team
• Strong interpersonal communication skills. 
• Experience producing clear, concise, and logical documentation for all cases
• Experience in a fast-paced, global organization
• Experience creating and running programs
• Experience solving problems through a data-driven approach
• Experience being customer service oriented

Qualifications: BS in Biology with 8 years of Experience

• Experience in having high integrity throughout every situation
• Experience producing excellent results and be meticulous, organized and time-conscious
• Able to exhibit professionalism by understanding appropriate corporate/workplace behavior/communications
• Able to analyse and interpret clinical trial data
• Able to interact with colleagues in research
• Able to demonstrate and share a clear understanding of early clinical development and Translational Medicine
• Experience in multiple therapeutic areas, with a willingness to learn new indications (i.e., Ferring’s portfolio)
• Strong interpersonal skills, with strong communication and presentational skills, and who enjoys participating and interacting with other R&D disciplines and functions
• Ability to navigate in a global matrix structure and is at ease working cross-functionally with international colleagues
• Able to stretch or bring greater bandwidth in the short to longer term to provide medical and scientific input, also into late-stage clinical pharmacology, interacting with late-stage colleagues in the absence of dedicated resources for this discipline

Qualifications: BA in Medical Sciences with 10 years of Experience

• Knowledge and skills in the areas of medical affairs and R&D in the biopharmaceutical industry.
• Experience in leading teams in R&D (medical affairs and/or clinical development).
• Experience in fostering effective relationships with KOLs
• Experience in the development and execution of medical strategic plans through product life cycle management.
• Knowledge of legal, regulatory, and compliance regulations and guidelines.
• Experience in rare or genetic diseases
• Strong written and verbal communication skills as well as strong leadership and interpersonal skills.
• Ability to effect positive organizational change at the company and team levels.
• Understanding of internal and external promotional codes of practice and regulations
• Keen interest in collaborating with external experts (physicians and patients)
• Ability to prioritize and manage multiple projects simultaneously

Qualifications: BS in Pharmaceutical Sciences with 9 years of Experience

• Experience in a medical affairs function with a proven track record in a global healthcare organization in oncology
• Ability to drive processes and lead cross-functional teams while being an appreciated team member.
• Experience in managing teams across cultures and geographies.
• Understanding of and ability to act on cultural differences in a global environment
• In-depth knowledge of prostate cancer, its disease stages and treatments is ideal.
• Interpretation and communication of pre-clinical and clinical data
• Understanding of the late-stage drug development process at different stages
• Experience in developing and delivering presentations and publications
• Strong written and oral communication/presentation skills
• Experience in effectively managing risk and compliance issues

Qualifications: BA in Health Sciences with 10 years of Experience

• Experience in industry of Medical or R&D industry, with a solid track record of achievement in Medical Affairs in the biotech/pharma industry
• Experience within the hemophilia field would be advantageous
• Strong written and verbal English communication skills
• Ability to respond to rapidly changing environments and circumstances
• Able to operate in a matrix team-oriented structure
• Experience working in an international multi-country setting
• Experience working in an Alliance with external partner(s)
• Experience in roles outside of Medical Affairs (e.g. HEOR, R&D, clinical operations)
• Ability to manage complexity and cultural diversity
• Strong interpersonal, verbal and written communication skills
• Experience of participating in cross-functional teams
• Experience of working across and building effective working relationships between functions

Qualifications: BS in Biochemistry with 9 years of Experience