Clinical Development Associate Director

Collegeville, Pennsylvania
Closing date
Dec 5, 2022

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Pharmaceutical, Physicians/Nurses
Organization Type
Jobseeker Type
Are you a clinical operation professional looking for an exciting and varied role in a dynamic, high performing department? Are you currently in a scientific role but looking for a new challenge? This could be the job for you!

In Value, Evidence and Outcomes (VEO), we lead a wide variety of studies to support the development and reimbursement of GSK's innovative medicine portfolio. The VEO family is made up of Value Evidence scientists, epidemiologists, patient centered outcomes scientists, patient focused development leads, data analysts and modelers, as well as critical support functions of study delivery, project management, quality, and business operations who work together to deliver an expanding portfolio. We currently have an open position in VEO Study Delivery for the right candidate.

Remote working outside of listed locations may be considered for qualified applicants where the needs of the individual and the business can both be met.

The Role:

This Senior Study Delivery Lead role within VEO Study Delivery and Quality Operations involves the end-to-end design, execution, and reporting of clinical studies and trials.

Key attributes include scientific credibility, demonstrated ability to input to and influence studies/projects through scientific and operational expertise, and excellence in stakeholder management. This job requires the ability to lead and drive change, strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change and curiosity.

Essential behaviors include continuous improvement and learning, effectiveness at building networks of partners and stakeholders and the ability to lead and inspire others. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential.


This role includes responsibility and/or accountability for the set-up, coordination, execution, and delivery of the VEO portfolio in partnership with the Science Lead:
  • Planning and leading the delivery of VEO studies to timelines, quality, budget, company standards and scientific requirements; from concept protocol to final study report
  • Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports
  • Accountable for the study delivery strategy (e.g., country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc)
  • With the majority of VEO studies fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors
  • Ensure compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies
  • Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate
  • Work with matrix partners, Study Delivery Therapy Area Lead and/or manager to develop and manage study level budget within project budget allocation
  • Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills

The types of studies run by VEO include:
  • Interventional studies
  • Non-interventional studies using primary data collection, including prospective studies enrolling patients and or/HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g., with EMRs/chart abstraction), patient reported outcomes development and validation
  • Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence/incidence studies of exposure, risk factors and outcomes
  • Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients
  • Economic modelling studies and supplemental analyses of clinical trials/meta-analyses

The position will include:
  • Leadership of a study team with single point accountability for delivery of the study
  • Have primary responsibility and be the point of contact for interactions with Value Evidence Leaders/Scientists, Epidemiologists, Medicines leaders (e.g. MDLs, PPLs, GMALS), and other key stakeholder groups including data management, analytics, legal, compliance and project management
  • Lead and drive significant cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs. Be accountable for implementing new business processes and strategies; may also proactively identify issues and propose strategies to manage implications and risks on study timelines, budgets and goals.
  • Drive innovative approaches to study delivery through external facing advances in technology and sciences
  • Supporting technical and leadership development of Study Delivery staff via mentoring and coaching.

Basic Requirements
  • Broad understanding of the pharmaceutical industry and the clinical development process
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic matrix environment
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
  • Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
  • Excellent leadership skills
  • Excellent influencing and negotiation skills

Preferred Requirements
  • Bachelor's degree in life sciences or related discipline
  • 5 or more years of experience in clinical operations or clinical research
  • Broad understanding of the pharmaceutical industry and the clinical development process
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic matrix environment
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
  • Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
  • Excellent leadership skills
  • Excellent influencing and negotiation skills

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness

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.

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.

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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