Our client is a global pharmaceutical company based in Dublin. With a presence in over 90 countries world-wide, our client is partnered with many of the worlds most successful multinational pharmaceutical companies and is market leader in both male and female healthcare. The company has invested heavily in research and development and now has an exciting pipeline of drugs in late stage development.
The Global Medical Director (women’s health) will work closely with and report to the CMO supporting on issues of medical, scientific and ethical nature, enabling informed and sound decisions relating to medical, clinical, business development and medico-regulatory activities.
S/he manages and provides strategic direction acting as the Medical Affairs function at a regional and global level. The appointee will create and implement Medical functional strategies that are integral to an aligned strategic vision and creating maximum opportunity in regions and at an overarching global level.
The Medical Director will support the CMO by providing medical and scientific expertise to drive optimal strategic medical strategic direction, including clinical development planning, business development clinical assessment, relationship management with leading research physicians, critical evaluation of current literature, and in other domains where medical and scientific expertise is required, data generation projects, medico-regulatory life cycle management, KOL mapping and management and building internal medical affairs connectivity and expertise. This role will also be responsible for management of investigatory initiated studies across a board and diverse portfolio and for management of the scientific publications and communications strategy and planning.
LCM for base business
Development and roll-out of global medical strategy for responsible portfolio
IIR assessment and member of study review committee
Oncology (surgical) experience and knowledge (breast cancer)
Sound understanding of research methodology and quality of evidence generation
KOL mapping and management
Internal scientific communication
Business development clinical assessment capabilities
Firm understanding of bioequivalence studies and requirements for highly variable drugs
Real world evidence and use of RWE in data generation and to support regulatory submissions.
Experience with FDA, EMA and CFDA agencies
Conduct of advisory board meetings including virtual advisory board meetings.
Literature review and identification of search terms to address research question.
Critical appraisal of the literature
Experience in Asian medical affairs / clin development
Therapy area strengths :
Endocrinology (male health, hormonal therapy ; hypogonadism)
Human microbiome / microbiology
Oncology (breast cancer)
Paediatric rare disease
Women’s Health (HRT)
Internal medicine / general medicine
Core Medical Affairs :
- Development of global medical strategy for responsible portfolio
Evidence Generation :
- Point of contact for external investigators requesting investigator-initiated study (IIS) support
- Support Head of Clin Development
- Support BH Clinical team with company sponsored studies at global level
- Mapping of international disease registries
- KOL mgt, mapping, academic bodies, form external scientific partnerships, scientific competitive intelligence
- External face of BH for relevant external partners
Patient Safety :
- Act as senior champion for patient safety
- Encourage internal colleagues and external customers to report all product complaints and adverse events to the company promptly
- Assist PV with signal detection
- Scientific leadership working transversally with clinical development, GRA, GQA, business development and project management
Experience and Education Required :
- Medically-qualified with license to practice medicine.
- Previous clinical practice experience in a relevant therapy area.
- Previous corporate/industry experience (pharma, medical devices, healthcare, insurance, public health).
- Post-graduate qualification if pharmaceutical medicine or related discipline
- Post-graduate qualification in surgery (MRCS, FRCS etc.)
- Experience of undertaking clinical research
- People management experience
Cv to email@example.com