Senior Director - Clinical Development , Otlimab (COVID-19)

Job description :

Site Name: Belgium-Wavre, India - Karnataka - Bengaluru, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, Warsaw Zwirki Wigury, UK - London - Brentford

- As the Sr. Clinical Development Director for Otilimab, you will be the Global Clinical Development Leader (CDL) for several clinical trials to support clinical development for regulatory approvals of Otilimab. You will work closely with the Medicine Development Lead (MDL) for GSK’s Otilimab COVID-19 program. 

- The position reports into the Vice President, Disease area lead for Hepatology/Gastroenterology, will be a member of the medicine development team and will be responsible for direct reports.

Job purpose and key responsibilities:

- Leading the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development

- Ensuring alignment with and support of project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP

- Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patients in the shortest possible timeframe

- Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP

- Supervision of ongoing clinical studies of Otilimab in COVID-19 and related COVID conditions including prospective phase 2 trials, as well as phase 3 trials to support regulatory approvals globally.

- Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.

- Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development

- Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members

- Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for Otilimab COVID studies in development

- Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, Clinical Research Organizations, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs

- Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile.

- Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches

- Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses

- Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery

Why you?

Basic Qualifications:

- Bachelor’s degree in a science related field

- Significant experience in clinical drug development of immunological diseases with an understanding of immunological diseases, the underlying biology and potential therapeutic targets as well as current and future potential treatment options

- Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.

- Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area

- Solid understanding of needs and priorities of regulators, payors and prescribers in relevant market(s)

- Demonstrated experience using new learning and digital tools to create innovation in other areas 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

- Demonstrated experience integrating genetic data to inform and guide clinical protocols

Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions.

Preferred Qualifications:

- MD, PhD or PharmD degree valuable

- Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance

Why GSK?

Our values and expectations are 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:

- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.

- Managing individual performance.

- Creating a performance culture and driving results, prioritisation, execution, delivering performance.

- Setting strategic direction and leading on-going organisational transformation.

- Building a resilient organisation.

- Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.

Closing Date for applications: 9th July 2021

- As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

- As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

- We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

- Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391

- As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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