Executive Medical Director, Clinical Development Lead Hematology

Role Summary

Executive Medical Director, Clinical Development Lead (CDL) – Oncology, will be the single point of accountability for the Clinical Development Plan (CDP) and provide clinical and strategic leadership to the program. The CDL leads cross-functional teams, oversees disease strategies, indications and associated clinical trial program data and integrity, and maintains overall benefit:risk for the program. This role requires on-site presence at designated sites with locations including USA - Pennsylvania - Upper Providence and UK – London, with a hybrid arrangement and a minimum of two days on-site per week.

Responsibilities

• Act as the single point of accountability for clinical development plans (CDPs) of an asset. Oversight of disease strategies, indications and associated clinical trial program/study data and integrity.
• Participate as a core member of the Medicine Development team or Early Development Team and provide a single Clinical Development accountability at the program level within these teams and other cross-functional partnerships with Medical Affairs, Integrated Evidence, Publications, and Global and Regional Commercial functions
• Accountable for overall benefit:risk of a clinical program. If not a physician, the CDL is expected to delegate to and interface closely with an appropriate physician on the program
• Lead cross-functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program
• Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment to enable effective and efficient CDP execution.
• Contribute strategic guidance and highlight clinical considerations to inform portfolio development strategies, individual study design and conduct, combination strategies, and disease area strategies
• Interpret complex clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries
• Prepare for governance discussions in close collaboration with cross-functional Medicine Development Leader (MDL) and other business lines
• Manage a team of physicians and/or scientists and allocate resources across the program

Additional Responsibilities

• Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and content.
• Contribute to the establishment of standards for clinical documents and data review processes across Oncology Clinical Development.
• Participate in interpretation of data analyses of clinical trial results and support development of clinical study reports
• Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, annual reports, etc.)
• Serve as program clinical expert for internal and external collaborators, investigators, consultants, and contract resources
• Lead and provide clinical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
• Lead recruitment, hiring and training for his/her direct report team roles
• Provide direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins and 1:1 meetings

Qualifications

• Required: Medical degree with completion of a formal primary medical clinical training program
• Required: Advanced pharmaceutical clinical research experience in field of Hematology/Oncology.
• Required: Experience in clinical research and drug development with a focus in multiple myeloma
• Required: Matrix team experience within a clinical development setting
• Required: Experience preparing clinical oncology sections for regulatory submissions and responding to health authority questions
• Required: Experience working with oncology external investigator networks and leading advisory or investigator meetings.
• Required: Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions.
• Required: Cross-functional oncology medicine development knowledge and business acumen.
• Required: Track record of scientific publications, abstracts or presentations from clinical studies.
• Preferred: Completion of hematology/oncology specialty training leading to recognition as a medical specialist through formal registration, board certification or country-specific professional designation
• Preferred: Experience leading and mentoring teams of physicians, medical directors or clinical scientists.
• Preferred: Highly effective communication skills; able to present complex data, design, strategy to groups at all levels of the organization.
• Preferred: Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
• Preferred: Ability to adjust behaviors and priorities based on changing environment and dynamics.
• Preferred: Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a clinical perspective.
• Preferred: Ability to engage in, and contribute to, Oncology Clinical Development Culture and broad GSK environment with confidence, impact, integrity and professionalism.

Additional Requirements

• Hybrid work arrangement; regular on-site presence as agreed with your hiring manager and team.
• This role is on-site at designated sites (USA or UK) with location options including USA - Pennsylvania - Upper Providence and UK – London, and requires a minimum of two days on-site per week.