Executive Director, Clinical Development Lead - Oncology at GSK

Upper Providence, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development, Oncology, Leadership, Cross-Functional Collaboration, Clinical Trial Management, Data Analysis, Regulatory Compliance, Team Management, Strategic Planning, Scientific Communication, Risk Assessment, Clinical Expertise, Problem Solving, Negotiation, Influencing Skills, Pharmaceutical Knowledge

Industry

Pharmaceutical Manufacturing

Description

Executive Director, Clinical Development Lead - Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary: The Executive Director, Clinical Development Lead (CDL) – Oncology, will be an integral part of one of the 4 mechanistic platforms as the single point of accountability for the Clinical Development Plan (CDP). The CDL provides clinical and strategic leadership to the program. Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. or Waltham. MA); or Poland (Warsaw). Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Act as the single point of accountability for clinical development plans (CDPs) of an asset. Oversight of disease strategies, indications and associated clinical trial program/study data and integrity. Participate as a core member of the Medicine Development team or Early Development Team and provide a single Clinical Development accountability at the program level within these teams and other cross-functional partnerships with Medical Affairs, Integrated Evidence, Publications, and Global and Regional Commercial functions Accountable for overall benefit and risk of a clinical program. If not a physician, the CDL is expected to delegate to and interface closely with an appropriate physician on the program Lead cross-functional Clinical Matrix Team and provide clinical leadership, Oncology Clinical Development expertise, and customer insight for the program Guide direct reports to ensure cross-functional integration, coordination, collaboration, and alignment to enable effective and efficient CDP execution. Contribute strategic guidance and highlight clinical considerations to inform portfolio development strategies, individual study design and conduct, combination strategies, and disease area strategies Interpret complex clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries Prepare for governance discussions in close collaboration with cross-functional Medicine Development Leader (MDL) and other business lines Manage a team of physicians and/or scientists and allocate resources across the program Additional responsibilities include: Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and content. Contribute to the establishment of standards for clinical documents and data review processes across Oncology Clinical Development. Participate in interpretation of data analyses of clinical trial results and support development of clinical study reports Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, annual reports, etc.) Serve as program clinical expert for internal and external collaborators, investigators, consultants, and contract resources Lead and provide clinical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards) Lead recruitment, hiring and training for his/her direct report team roles Provide direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins and 1:1 meetings Basic Qualifications: We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Advanced degree Required, PhD/PharmD Minimum of 8 years pharmaceutical or relevant scientific/medical/clinical experience required, with a minimum of 5 years in Oncology (clinical development experience in one of the 4 strategic areas of focus is preferred). Cross-functional medicine development knowledge and business acumen. Experience with writing scientific communications with clarity, accuracy and rigor and in compliance with GSK control documents governing disclosure, publication and principles of scientific exchange. Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions. Preferred Qualifications: If you have the following characteristics, it would be a plus: Medical Degree and Oncology board certification/eligibility/registration. In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations In depth knowledge of medical and drug terminology and a sound foundation in pharmacology. Highly effective communication skills; able to present complex data, design, strategy to groups at all levels of the organization. Comprehensive understanding of product and safety profiles Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.) Experience leading matrix teams with a strong reputation of inspiring and motivating high performance. Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context. Ability to adjust behaviors and priorities based on changing environment and dynamics. Ability to engage in, and contribute to, Oncology Clinical Development Culture and broad GSK environment with confidence, impact, integrity and professionalism. Demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients. Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a clinical perspective. Why GSK? At GSK, we are committed to creating an inclusive workplace where everyone can thrive. We value innovation, teamwork, and a shared dedication to improving patient lives. If you are ready to lead transformational change in oncology clinical development, we encourage you to apply. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Responsibilities

The Executive Director, Clinical Development Lead will be accountable for the Clinical Development Plan of an asset and provide clinical and strategic leadership. This role includes oversight of clinical trial programs, guiding direct reports, and contributing to regulatory filings.