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Senior Clinical Development Director posted by GlaxoSmithKline

Full Time
New York

Job Description


Senior Clinical Development Director

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Senior Clinical Development Director


GlaxoSmithKline is a uniquely science-led global healthcare organization on a mission to help people do more, feel better, and ultimately live longer.
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About This Job


* Uxbridge, United Kingdom

Your Responsibilities:
The Benlysta Clinical Team comprises physicians and scientists delivering transformational treatments for immunology/related diseases. Joining the team you will be providing clinical leadership and expertise for evidence generation, regulatory submissions and clinical/scientific content delivery of the trial programs according to quality standards, timelines and budget measures. There is also opportunity to lead global cross-functional team for clinical trial delivery and contribute to strategic planning and execution for progressing the immunoinflammation pipeline.

The key elements of the role are to provide:
* Clinical leadership and disease expertise in study delivery, indication expansion and regulatory interactions with EMA and FDA for major submissions
* Cross-functional leadership to ensure an integrated approach to evidence generation
* Input to clinical strategy, study design, protocol development, data analysis plan, study reporting and other clinical aspects of the project delivery
* Clinical input to and leadership in risk assessment, mitigation and medical governance
* Guidance and implementation of measures to ensure trial subject safety and management of safety related issues
* Clinical point of contact for the responsible program on behalf of GSK for external collaborators, regulatory agencies and GSK LOCs.
* Contribution to Benlysta Safety Review Team, Clinical Metrix Team, Integrated Evidence Team and Benlysta R&D/Franchise interactions
* Oversight of Clinical Trial Programs and/or Talent/team development and line management, if appropriate

Why You?

Basic qualifications:
Medical degree with UK General Medical Council (GMC)/US Board Certification or equivalent status required.
R&D or Medical Affairs experience in Pharmaceutical industry is required.
Expertise in immunology, rheumatology, nephrology, oncology or other immunoinflammation related disease areas is required.

Additional Skills required:
- Drug development knowledge and experience: experience in the design, execution, statistical analysis, reporting and data interpretation of clinical studies
- Therapy area expertise and experience in biopharmaceutical development in immune-mediated diseases
- Experience in developing clinical/Medical strategy for a therapeutic area or global trial program(s)
- Driving a disciplined approach to clinical research by ensuring a relentless focus on quality, compliance, scientific rigour and execution excellence
- Strong leadership skills: science-focused, strategic thinking, drive performance, and ability to execute the assigned role(s) in a global matrix setting
- Excellent communication and presentation skills: ability to communicate effectively with credibility, accuracy, and confidence with internal and external stakeholders, experts and regulators
- Strong Scientific Writing: written communications with clarity, accuracy and rigour
- Discipline of forward planning, organising and managing resources for successful project delivery
- Ability to learn and adapt to new business environment quickly and efficiently

Please use the cover letter of your CV to highlight how you meet the competencies required for the role. Your cover letter along with your CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact Apply Now >>.
This will help us to understand any modifications we may need to make to support you throughout our selection process.


Preferred qualifications:
as above

Why GSK?:
GSK is a science-led global healthcare company with a special purpose: do more, feel better and live longer.
We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies

At GSK we are all inspired by the difference we make and challenge ourselves every day to improve the lives of patients and consumers. That's why we have created an environment where everyone feels valued, able to develop, contribute to our mission and be proud of what we achieve.

Contact information:
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at Apply Now >> (US Toll Free) or +Apply Now >> (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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About GlaxoSmithKline

GlaxoSmithKline is a uniquely science-led global healthcare organization on a mission to help people do more, feel better, and ultimately live longer.

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