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Clinical Development Director, Nephrology

Employer
GSK
Location
Collegeville, Pennsylvania; Rockville, Maryland; Research Triangle Park, North Carolina; Waltham, Massachusetts
Salary
Competitive
Closing date
Dec 1, 2022

View more

Discipline
Health Sciences, Medicine
Job Type
President/CEO/Director/VP
Organization Type
Pharma
As the Clinical Development Director, daprodustat, you will be responsible for working with the Clinical Development Lead (CDL) for daprodustat, the Disease Area Lead (DAL) and other senior leaders in the Gastroenterology/Hepatology/Renal disease area to advance our clinical programs to treat the anemia of patients with chronic kidney disease (CKD). You may be provided the opportunity to support regulatory filings for daprodustat, support preparation of scientific presentations and publications and to work with our colleagues in global medical affairs to communicate the medical and scientific value that daprodustat provides to patients with CKD as well as design Phase 3b/ clinical trials.

This role will provide YOU with the opportunity to lead key activities to progress YOUR career; these responsibilities include some and/or all of the following:
  • Act as Clinical Science Lead (CSL) for phase 3b/IV trials
  • Physicians only: Act as medical monitor for phase 3b/IV trials
  • Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated evidence plan, and the clinical development plan
  • Generating data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
  • Communicating the benefits as well as the potential risks of daprodustat to patients with CKD through scientific publications and presentations at professional scientific meetings
  • Leading and positively interfacing with a diverse range of scientific external experts (e.g. regulators, payors, clinical research organizations, consultants, investigators) in order to deliver the integrated clinical development strategy, aligned with the business strategy to achieve mutual goals related to patient needs
  • Developing and maintaining relationships with program counterparts in Global Medical Affairs, Commercial, Research, Regulatory, Clinical Operations and Statistics
  • Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Sciences
  • Delivering value and accessing insights to inform medical strategy, expand market access and to address unmet patient needs
  • Leading and/or supporting clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
  • Providing effective leadership support / oversight of evidence generation activities to assure patient safety and study delivery
  • Anticipating problems and proactively seeking input from other team members/functional lines within R&D.
  • Using scientific/operational expertise to solve study and/or project related problems
  • Overcoming obstacles by experimenting with and adopting new ways of working including digital tools and technology
  • Championing implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Physician background (medical degree with significant clinical experience and ideally pharmaceutical industry experience, particularly in clinical development/trials OR Science PhD and/or PharmacyD degree, or considerablewith pharmaceutical development experience
  • Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication
  • Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
  • Significant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance
  • Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Extensive experience in clinical drug development for CKDfor renal or hematology products, with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
  • Medical degree with clinical and/or clinical development experience in CKD


#LI-GSK

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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