This position may be available in the following location: US – Remote
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 12,500employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Position Summary:
The Senior Director will be responsible for the clinical strategy for programs enabling Pharma, Consumer and/or Surgical new product development. This leader will have accountabilities for all clinical deliverables in the assigned program or programs. The Senior Director will drive execution of the assigned clinical program in partnership with other partner line functions. In this role the incumbent will be accountable for the sufficiency of clinical development business deliverables to meet global regulatory requirements. The Senior Director will play a critical role in building and progressing Bausch and Lomb’s pipeline through partnering with the R&D business unit heads, Research and External Scientific Innovation, Clinical Services, Regulatory and Medical. Excellent communication skills are necessary to influence both internal and external stakeholders. This position reports to the Pharmaceutical and Consumer Business Unit Head.
Key responsibilities:
- Business deliverables may include the clinical development strategy for assigned program(s), clinical sections of individual protocols, clinical data review, clinical components of regulatory documents/registration dossiers, and publications.
- Leads development of clinical sections of study and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities).
- Ensures ongoing medical and scientific review of clinical scientific data.
- May lead a clinical development sub team acting as a lead communicator for the clinical program to both internal and external stakeholders.
- Provides clinical/scientific input into disease area strategies.
- Provide clinical expertise at advisory boards, patient advocacy groups and major congresses.
- Interfacing with global health authorities and key opinion leaders as a technical authority in clinical development
- Provide technical evaluation and appropriate recommendations to support search and evaluate efforts.
- Contribute to prioritizing innovation opportunities to enable the building of a balanced risk pipeline.
- Identify, rationalize, and build necessary capabilities both internally and externally to deliver a best-in-class pipeline.
- Build on Bausch + Lomb’s legacy as an eye care scientific and clinical leader through establishing robust clinical development programs that advance science for patients.
- Develop productive collaborations with internal cross-functional partners within R&D and the broad Bausch + Lomb organization.
- Ensure productive collaborations with external partners such as vendors, partner companies and academics.
Qualifications/experience:
- Advanced degree in life sciences/health care in a clinically relevant area is required. MD, PharmD or PhD is strongly preferred with at least 10 years of industry experience with demonstrable impact in leading clinical activities Phase 1 through 3.
- Experience in eye health product development in multiple geographic regions with a track record of successful product registration.
- Experience developing and registering drugs including small molecule, biologics, and devices.
- Demonstrated ability to establish strong scientific partnership with key stakeholders.
- Knowledgeable of GCP, clinical study design, statistical analysis methodology, and regulatory/ clinical development process
- Experience leading teams to deliver clinical development data packages as a functional line and matrix leader.
- Effective interpersonal and communication skills and proven ability to collaborate across multi-disciplinary teams and leading and navigating in a matrixed organization.
How to Apply: https://careers.bauschlomb.com/job/USA-Remote-Sr-Director%2C-Clinical-Development-USA/782003202/