Medical Director Clinical Development HematologyOncology
Medical Director Clinical Development HematologyOncology
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1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
The Medical Director of Hematology/Oncology provides medical monitoring to multiple clinical trials. Additionally the Medical Directorguidesthe project teams to design and implement clinical studies at high quality and in a time and costeffective manner in line with the department andcorporategoals and within regulatory and resource guidelines.
Responsibilities
Provide medical monitoring to multiple hematology/oncology clinical trials
Lead project/study teams to design and implement hematology/oncology clinical studies
Write protocols investigator brochures clinical study reports and review clinical trial documents
Conduct investigator meetings and lead site initiation visits with clinical trial investigators
Implement and deploy drug development strategic plansdevelopcontingency plans provide technical and strategic advice and meet milestones and budgets
Translate findings from research and nonclinical studies into clinicaldevelopment opportunities
Interactwith clinical investigators andthought leaders
Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry and ensure compliance with these external guidelines
Work with internal preclinical scientists translational scientists business and commercialorganizationsin across functionalmanner.
Work in a crossfunctional teamenvironment including with clinical operations biomarker specialists CROs and regulatory affairs
Provide clinical expertise and input for regulatory filings (i.e. BLA MAA) as well asresponseto questions from regulatory authorities in the context of IND submissions clinical trial applications or filing procedures
Provide clinicalguidanceand work in a teamenvironmentin interactions with external stakeholders (medicalexperts advisory boardspatientadvocacy groups) and internal stakeholders (Research Translational Sciences Clinical Operations Safety Regulatory Medical Affairs and Commercial)
Requirements:
MD/DO degree and clinical development experience in the pharmaceutical industry.
Board certification/specialization in Hematology or Oncology and experience managing oncology trials.
CART therapeutic area experience
Multiple myeloma disease area expertise
Phase 2 or 3 study experience in multiple myeloma CART trials within the pharmaceutical industry.
Relevant drug development experience either within industry or as a clinical investigator/physician scientist in academiaor equivalent experience.
Demonstratedclinical development strategist with experience designing implementing and conducting clinical trials with emphasis on latestage clinical development.
Knowledge of carrying out hematology/oncology clinical trials including knowledge of hematology/oncology treatment options
Strategicleadershipand tactical skillsexcellentinitiative and judgment
Demonstrated ability todevelopand maintainexcellentworkingrelationshipswith both internal colleagues and external contacts including keythought leaders and investigators
Demonstrated ability to work well in teams in across functionalmanner
Ability to communicate andwork in aselfguidedmanner with scientific/technical personnel
Ability to think critically and demonstrated troubleshooting and problemsolving skills
Selfmotivated and willing to accept temporaryresponsibilitiesoutside of initial job description
Comfortable in adynamicsmall companyenvironmentwith minimal direction and able to adjust workload based upon changing priorities
May travel up to 25
Applicants outside of Stockley Park may be considered if all the above requirements are met.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs companysponsored training education assistance social and recreational programs are administered on a nondiscriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Director
Employment Type
Full-Time
