Senior Group Medical Director, Clinical Development Lead – ImmunoOncology

Are you keen to join an emerging Oncology pharma company to be the single point of accountability forclinical development plans (CDPs) of an asset and have oversight of disease strategies,indications and associated clinical trial program/study data and integrity? If so, this Senior Group Medical Director, Clinical Development Lead opportunity at GSK is just for you.

The Senior Medical Group Director as the Clinical Development Lead (CDL)– ImmunoOncology, will be an integral part of one of the threemechanistic platforms (ImmunoOncology, Synthetic Lethalty and Tumor Cell Targeting) as 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 forclinical 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 Developmentaccountability 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 overallbenefit: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-functionalClinical Matrix Team and provide clinical leadership, Oncology Clinical Developmentexpertise, and customerinsight 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 highlightclinical considerations to inform portfolio development strategies, individual study design and conduct, combination strategies, and disease area strategies 

• Interpret complex clinicaldata 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 1:1meetings

• *LI-GSK

We are looking for professionals with these required skills to achieve our goals:

• MD (or equivalent) with board certification/qualifications/registration (or equivalent)  in medical oncology. 

• At least 8 years pharmaceutical or relevant scientific/medical/clinical experience required, with at least 5 years in Oncology (clinical development experience in one of the 3 strategic areas of focus is preferred).

• In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

• Comprehensive understanding of product and safety profiles

• Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)

• Experience leading matrix teams with a strong reputation of inspiring and motivating high performance.

• Cross-functional medicine development knowledge and business acumen.

• In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.

• Highly effective and clear communication skills of the English language; able to present complex data, design, strategy to groups at all levels of the organization.

• Demonstrated ability to produce written scientific communications with clarity, accuracy and rigor and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange.

• Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions.

• MD/PhD

• 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. 

• Ability to engage in, and contribute to, Oncology Clinical Development Culture and broad GSK environment with confidence, impact, integrity and professionalism.

• Demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. 

• Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a clinical perspective.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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