Executive Medical Director, Clinical Development Lead Hematology

GSK•Upper Providence Township, PA

6d•Hybrid

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s US (PA or MA) or UK (Stevenage or London HQ) sites. The Executive Medical Director, Clinical Development Lead (CDL) – Oncology, will be the single point of accountability for the Clinical Development Plan (CDP). The CDL provides clinical and strategic leadership to the program. Key elements of the role include: 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 include: 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

Requirements

Medical degree with completion of a formal primary medical clinical training program
Advanced pharmaceutical clinical research experience in field of Hematology/Oncology.
Experience in clinical research and drug development with a focus in multiple myeloma
Matrix team experience within a clinical development setting
Experience preparing clinical oncology sections for regulatory submissions and responding to health authority questions
Experience working with oncology external investigator networks and leading advisory or investigator meetings.
Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions.
Cross-functional oncology medicine development knowledge and business acumen.
Track record of scientific publications, abstracts or presentations from clinical studies.

Nice To Haves

Completion of hematology/oncology specialty training leading to recognition as a medical specialist through formal registration, board certification or country-specific professional designation
Experience leading and mentoring teams of physicians, medical directors or clinical scientists.
Highly effective communication skills; able to present complex data, design, strategy to groups at all levels of the organization.
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.
Ability to adjust behaviors and priorities based on changing environment and dynamics.
Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a clinical perspective.
Ability to engage in, and contribute to, Oncology Clinical Development Culture and broad GSK environment with confidence, impact, integrity and professionalism.

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.
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
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