Executive Director, Global Clinical Lead CVM and Respiratory
Position Purpose: Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.
Key leadership role in the Clinical Development group, providing strategic and tactical medical leadership and guidance for the project-work of physician direct reports and supports their professional development. Will also function as the clinically representative on the Therapeutic Area Leadership team (TALT) for Respiratory.
Reporting Relationships: List other positions in the company that are reporting into this position or that this position reports into.
- Role that this position reports to
Vice President, Head of Clinical Development
- Role/s that may report to this position
Physicians with main project assignments in Respiratory and CVM Therapeutic Areas
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position (please limit the number of responsibilities to the primary ten.)
1. Providing strategic and tactical medical leadership and guidance for clinical development activities for 5-8 MD direct reports
2. Works with other MD Leads and Head of Clinical Development to ensure adequate resourcing across the portfolio.
3. Manages team of physicians in the Clinical Development group. Acts as a mentor, guides clinical development based on his/her expertise in all phases of clinical development in general and in specific areas of therapeutic knowledge.
- Contributes to global clinical development strategy for all projects in TA
- Ensures that high quality clinical & scientific content is provided into Regulatory submissions & ensures defense and negotiation with Regulatory agencies
- Leads/supports preparations for stage-gate evaluations and benefit –risk assessments
4. Oversees and supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CD and Global Project Leaders to ensure project alignment with TA strategy, achievement of CDT and PST commitments, timelines, budget and internal/external quality standards.
5. Ensures that the patient and physician voice is at the forefront in strategy development.
6. Builds networks with external experts
7. Drives excellence in clinical development execution
8. Inputs into to BD strategy & due diligence for TA & identifies and evaluates NPO’s
9. Partners with TA core, extended core & functional partners to ensure scientific & medically robust clinical dev & med affairs activities
10. Enhances the reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA
11. Represents the Co & TA externally with KOL, Health Technology and external authorities at key forums
12. Responsible for effective presentation at STRC, TPRC etc.
13. Will represent the clinical function on the Respiratory TALT, responsible for input into TALT strategy, oversee the quality of clinical plans in the Respiratory therapeutic area.
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
- MD, Board Certified (or non-USA equivalent) in Internal medicine with relevant sub-specialty highly preferred- if not Board Certified in relevant Subspecialty, then experience in that TA a must
- Clinical development experience leading a therapeutic area or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes is essential\.
- A minimum of 5 years’ experience preferred, acquired in either industry or academic positions, although the latter would also require experience in working with industry sponsors
- Outstanding influencing ability & collaboration skills
- Proven leadership experience
- Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups; particularly demonstrated ability to work across the critical interfaces between Clinical and functions
- Experience interacting with Health Authorities and designing programs that meet the needs of HA’s, commercial and payers
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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.
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