For one of our big pharma clients we are recruiting a Medical Director to join their team! This company is globally active and focuses on innovating therapies to improve the quality of life for patients worldwide. We are in search of top talent to help them meet their aggressive and important goals.
Summarized, the Medical Director, part of the Global Clinical Physicians and Operations (GCPO) Group ,is accountable to develop and execute a forward-thinking clinical strategy by supporting the cross functional core team as the medical expert in late stage development. The individual is expected to be experienced in drug development, and possess extraordinary leadership competencies and the perspective, insights to develop strategy around new innovative and established medicines. The position includes extensive involvement with global, regional and local Research & Development colleagues, Marketing and Sales, Business Development Opportunities, Regulatory and Health Authorities, Healthcare providers and Key Opinion Leaders. As part of their key deliverables, the Medical Director supports the strategy for Global Clinical Development after the POC until launch taking into consideration the medical, scientific, regulatory and commercial issues for assigned their products. They will be involved with development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan and its operational day-to-day activities that will result in the regulatory approval of the compound in multiple regions. The Medical Director oversees the creation of all types of clinical regulatory document (e.g., protocol, CSR, IB, and clinical sections of other regulatory documents) according to company guidelines and international governmental regulations and will present clinical data objectively in a clear, concise format.
ESSENTIAL DUTIES AND KEY DELIVERABLES
- Provide strategic input for the R&D pipeline to support existing and future products
- Critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Recommends high impact global decisions.
- Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labelling.
- Partners with business development to develop and pursue sound opportunities for new products through a focus on in-licensing of new compounds and technologies in late stage development.
- Support the development of reliable and high-value publication strategies for new and existing products
- Facilitate and merge strong science into commercially viable products utilizing aggressive timelines;
- integrate scientific rigor, medical need and commercial value into compelling clinical plans
- culminating in successful registration and launch
- Ensured regulatory compliance and adherence to GCP standards.
- Builds strong relationships and ties with outside stakeholders, including key opinion leaders and
- patient communities, as needed.
- Leads global & regional clinical and scientific advisory boards and liaises with global & regional key
- opinion leaders on generating ideas for future product/device development, expanded labeling of
- existing products/devices and scientific communication of safety/efficacy of current products.
- Pilots new projects involving the medical community in alliance with global functions.
- Supports regional Marketing by working closely with country scientific affairs managers on development of medical communication, advises primary marketing personnel regarding features, benefits and competitive advantages. Participates in local, state, national and international medical/industry governmental meetings, providing strategic guidance to the Division through participation in these key associations to influence policy and regulations regarding medical devices.
- MD, MD/MBA, MD/PhD required.
- Position will be filled at level commensurate with experience, with a minimum of 5-10+ years of pharmaceutical industry experience in clinical development functions across Phase I through IV required.
- Ophthalmology experience is strongly preferred.
- Experience in the successful development of rare disease therapeutics is preferred, but not required.
- Regenerative Medicine (Gene & Cell therapy) knowledge/familiarity would also be additive.
- More important than specific therapeutic expertise is the ability to be creative and strategic around developing processes that may be without precedent.
- Sound strategic scientific and clinical judgment.
- A strong business sense; able to link the scientific and business needs.
- Ability to travel from time to time.
- Excellent communication skills, self-motivated, innovative, with highest level of professional ethics, accountability and integrity.
- Experience leading and collaborating cross-functionally with R&D and non-R&D key partner groups, thereby helping to shape the future of the entire their organization.
- Experience with clinical study design, health economics or medical statistics.
- Team oriented with the confidence, maturity and integrity to work effectively with their senior leaders, key opinion leaders and health care professionals.
- Able to demonstrate a high level of strategic thinking and business acumen within a strong and well educated group in order to effectively manage internal and external relationships and gain credibility in the role.
For more information please get in contact with Ivor Duif (Principal Consultant) via email@example.com or +3120 20 44 502.