Director, Clinical Research & Development Physician

Responsible for medical oversight of clinical studies within the assigned therapeutic area as the Medical monitor. Serves as a medical representative on the cross-functional therapeutic area, development teams and/or post-marketing product teams. Ensures medical standards and processes are in alignment with CSL Behring processes and GCP as well as internal and external stakeholders including regulators, governmental agencies, payers, physicians (KOLs and Investigators), patients and the general public. Responsible/contribute for the generation of key study documents, including but not limited to CSP, CSR, IB, supporting responses to regulatory agencies and IRBs/ECs or other regulatory submission documents.
 

This position reports to the Physician Lead, Hematology TA

Main Responsibilities and Accountabilities:

- You will provide your medical expertise for clinical study oversight and safety concerns within the assigned therapeutic area as the Medical monitor. Present results to Safety Monitoring Committee and other internal and external meetings. Provide medical and scientific input for the safe, efficient, and timely execution of assigned clinical programs.

-You will review the data generated during the execution of a study to gather a medical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy.

-Be responsible for or participate in the ongoing data reviews. Contribute to the drafting/review of clinical study protocol/reports and other documents. Provide medical insight to the draft or draft responses to regulatory agencies and IRBs/ECs or other regulatory documents.

-You will be responsible for setting technical medical strategies for global projects and therapeutic areas, consistent with functional expectations.

-Identify potential challenges, risks and roadblocks associated with the global medical strategy and works as a leader in developing solutions to address these, working cross-functionally and inter-functionally with other departments.

-Interfaces with key high-level internal and external stakeholders; contributes to regulatory reports/submissions/inquiries.

Position Qualifications and Experience Requirements:

Education

MD (Medical Doctor degree) or international equivalent is required

Experience

• Two (2) years minimum experience as a physician in patient care.
• Three (3) years minimum clinical research experience in or for pharmaceutical/biotechnology industry, with one of which include experience of study data review/evaluation in a pharmaceutical or clinical study environment.
• Clinical or industry experience in Hematology, Gene Therapy desired but not required
• Experience in addressing and managing complex medical issues

Competencies

• Strong communication and presentation skills
• Excellent analytical thinking and scientific/medical writing skills
• Strong contributor within a matrix environment
• Demonstrated capabilities with project management
• Builds bridges and proactively improves cross-functional collaboration 

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.