Senior Director Medical, Clinical Development (UK/GER/FR/ES/IT/Switzerland)
Senior Director Medical, Clinical Development (UK/GER/FR/ES/IT/Switzerland)
United Kingdom - Uxbridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day - discoveries that include our own capabilities and our individual potential.
We're currently seeking to recruit a highly motivated Senior Director Medical, to join us and be part of our exciting journey in the development of innovative cancer cell therapy and their translation to the treatment of patients with cancer. This position will report to the Vice President of Clinical Development.
As a Senior Medical Director, Clinical Development you will provide clinical leadership to cellular immunotherapy clinical study teams developing transformative therapies for life-threatening hematologic malignancies or solid tumors, leading to regulatory submissions and approvals.
You will have demonstrated expertise in clinical research of malignant disorders in a biotech/pharma setting and will have provided input to product teams on clinical studies, program strategies, and life cycle management.
You will be the clinical leader on study teams and will work closely with cross-functional groups that include Pre-Clinical Research, Translational Sciences, Clinical Operations, Clinical Science, Regulatory Affairs, Biometrics, Patient Safety, Medical Affairs, and Commercial groups to ensure that Clinical Development strategies are aligned with broader corporate and patient needs.
You will have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards.
Your Responsibilities will be (included but are not limited to):
- Develop Kites disease strategy while overseeing more than one indication or more than one product
- Lead study teams to strategically design and implement hematology/oncology clinical studies
- Write or review protocols, investigator brochures, clinical study reports, IND and NDA documents
- 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
- Conduct investigator meetings, advisory board meetings, and site initiation visits
- Execute 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
- Provide clinical leadership 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 Science, Biometrics, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
- Provide strategic support and work closely with Medical Affairs, including the Medical Science Liaison (MSL) field force
The ideal candidate for this position will have the following qualifications:
- MD degree or equivalent is required, with preference for board certification/specialization in Hematology or Oncology and patient-care experience
You should have at least three years of relevant drug development experience, preferably within industry or equivalent experience, and you should be able to demonstrate experience on the following topics:
- Proven clinical development strategist with experience designing, implementing, and conducting clinical trials, with emphasis on first-in-human studies or global registration studies
- Knowledge of hematology/oncology disease management and treatment options
- Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of Kite
- 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
- Possess an understanding of applicable drug development regulations and GCP
- Ability to communicate and work independently with scientific/technical personnel
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
- Excellent written and oral communication skills, including presentation skills
- May travel up to 25-30%
As we extend our global reach, we need leaders interested in change, in challenge, and in building a new future together.
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don't miss out on this opportunity to join us and discover your sense of purpose.
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, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's 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 log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Senior-Director-Medical--Clinical-Development--UK-GER-FR-ES-IT-Switzerland-_R0015232-1
Copyright 2017 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency