Posted in Health Care 30+ days ago.
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Location: Philadelphia, Pennsylvania
Position Title: VP/Head of Clinical Development-ONCOLOGY
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: 10 years
Required Education: Medical Doctor
Travel Required: 0%
GSK Oncology includes clinical development of one or more assets in Immuno-Oncology (IO), Oncology Cell Therapy (OCT), and Cancer Epigenetics (CE). These three Discovery Performance Units (DPUs) focus on developing innovative therapeutics for treating various oncologic and hematologic indications.
In IO, anti-BCMA antibody-drug conjugate has demonstrated unprecedented efficacy (~60% overall response rate) in refractory/relapsed multiple myeloma. Other IO assets include the first-in-class anti-ICOS agonist antibody, anti-OX-40 agonist antibody, TLR4 agonist, and multiple near clinical stage assets.
In OCT, GSK recently excised the early opt-in option for an investigational NY-ESO-1 TCR-modified T cell therapy from AdaptImmune. This novel cell therapy delivered a 50% ORR in synovial sarcoma, and it being investigated in multiple other solid tumors.
The CE clinical pipeline includes multiple clinical stage assets including BET, LSD1, and PRMT5 inhibitors.
EXPERIENCE / ACCOUNTABILITIES
GSK seeks an outstanding oncology physician executive to join the leadership team of Dr. Axel Hoos, Senior VP- Oncology Therapy Area Head. Accountabilities are as follows for Clinical Components of Medicine Development of all assets in the Oncology Therapy Area Unit:
o Provides a single Clinical Development/Medical point of contact for the TAU and its portfolio to the leadership of the MDTs, DPUs, the preclinical function leads, as well as Medical Affairs, Commercial, Health Outcomes and other relevant functional partners in establishing disease area strategy and E2E medicine vision;
o Leads pipeline delivery by ensuring accuracy, quality and timeliness of CDPs, as well as clinical components of required regulatory and market access submissions, throughout the life cycle;
o Leads project oversight to ensure timely, efficient, and compliant delivery of clinical activities according to GSK metrics and policies, working with the Projects, Clinical Platforms and Sciences TAU lead.
o Provides advice and guidance on specific clinical development, marketed product management, and safety/efficacy issues
Accountable for Medical Governance
• Provides clinical/medical leadership, advice, and guidance for the accountable Physician Project Leaders to ensure overall safety of study subjects and scientific integrity of GSK clinical trials
o Supports/Foster interactions with the Global, Regional, or Local Medical Affairs Leaders in their accountability for Medical Governance of interactions with external communities about science and medicine (including the provision of medical information to healthcare professionals) and promotional practices are conducted to the highest standard
o Supports & Foster interactions with the Global Clinical Safety and Pharmacovigilance leaders in their accountability for Pharmacovigilance to protect patient safety and wellbeing
o Ensures timely and proper disclosure of clinical research and results
Develop, manage, and allocate clinical resources across projects and programs
• Attract, retain and mentor clinical staff
• Manage clinical resource across discovery/early stage programs, late stage projects, marketed product programs, due diligence activities, and other clinical activities within the TAU according to the priorities of the portfolio
Enhance delivery & improve end-to-end pipeline productivity and IRR
• A clear disease area strategy, medicine vision and OneCDP/IEP
• excellent medical governance of all clinical trial activities
• robust scientific engagement of external stakeholders
• effective and dynamic clinical resource allocation especially in high priority projects
Drive simplification and reduce complexity across R&D
• Fully outsourced clinical studies where appropriate
• Explore opportunities for simplification at TA level and organizational level
Enhance organizational decision-making at all levels
• Contribute to simplification and clarification of R&D governance and decision milestone process
o HUP support to optimal decision making at project level.
o Early decision making through an Experimental Medicine, innovative trial design and Question-based approach through Protocol Review Forum
• clinical protocols are reviewed by a defined TAU PRF
• Embed Clinical Trial Diversity principles through the PRF
Improve the R&D Commercial interface
• appropriate patient, physician and payer insight is incorporated for all clinical stage assets for smooth project transition at C2F&L
Develop, embed and maintain key Development capabilities
• Ensure support to implement the 5 high priorities cross cutting areas: Real World Evidence, R&D Franchise optimization, Patients in Partnership, CRO Partnership Excellence and Digital Data Strategy).
Please provide a Cover Letter as this will be reviewed closely as part of the application review process.
Oncologist with significant pharmaceutical Oncology therapy area clinical development leadership experience.
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.