Senior Medical Director Clinical Development MD Rheumatology
Senior Medical Director Clinical Development MD Rheumatology
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$ 274550 - 355300
1 Vacancy
Job Description
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were not finished yet.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
Job Description
Everyone at Kite is grounded by one common goal curing cancer. Every single day we seek to establish a direct line between that purpose and our daytoday work. Would you like to join us in this mission
We are seeking a highly motivated individual to join us as Senior Medical Director Clinical Development (MD) Rheumatology. The Senior Medical Director provides clinical oversight to one or more clinical trials. Additionally the Senior Director guides the project teams to design and implement clinical studies at high quality and in a time and costeffective manner in line with the department and corporate goals and within regulatory and resource guidelines.
Responsibilities
Provide clinical oversight and medical monitoring to one or more clinical trials
Lead project teams to design and implement 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 plans develop contingency plans provide technical and strategic advice and meet milestones and budgets
Translate findings from research and nonclinical studies into clinical development opportunities
Interact with clinical investigators and thought 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 commercial organizations in a cross functional manner
Work in a team environment comprising clinical operations biomarker specialists CROs and regulatory affairs
Provide clinical expertise and input for regulatory filings (i.e. BLA MAA) as well as response to questions from regulatory authorities in the context of IND submissions clinical trial applications or filing procedures
Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts advisory boards patient advocacy groups) and internal stakeholders (Research Translational Sciences Clinical Operations Safety Regulatory Medical Affairs and Commercial)
May present scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable takes a lead on authoring scientific publications
May assist in the clinical evaluation of business development opportunities
Basic Qualifications
MD/DO and 6 years of clinical scientific and/or drug development experience in the biopharma industry healthcare consulting academia
Preferred Qualifications
Board certification/specialization in rheumatology
Experience managing phase 13 trials; latestage experience strongly preferred
Drug development experience either within industry or as a clinical investigator/physician scientist in academia or equivalent experience; drug development experience in autoimmune diseases
Demonstrated clinical development strategist with experience designing implementing and conducting clinical trials with emphasis on late study trial designs.
Experience in regulatory interactions in latestage clinical drug development is preferred e.g. interactions regarding pivotal trial designs primary analysis BLA sBLA etc.
Strategic leadership and tactical skills excellent initiative and judgment
Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts including key thought leaders and investigators
Demonstrated ability to work well in teams in a cross functional manner
Ability to communicate and work in a selfguided manner with scientific/technical personnel
Ability to think critically and demonstrated troubleshooting and problemsolving skills
Selfmotivated and willing to accept responsibilities outside of initial job description
Comfortable in a dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities
May travel up to 25
The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us
For additional benefits information visit:
As an equal opportunity employer Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance. For more information about equal employment opportunity protections please view theKnow Your Rights poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Director
Employment Type
Full-Time
