Clinical Development Physician

Make your mark for patients

We are looking for a Clinical Development Physician who is dynamic, has a strong value commitment, and is experienced in Drug Development to join us in our Global Clinical Development department, based in our RTP office in Raleigh, NC.

About the role

The Clinical Development Physician is accountable for the medical content and integrity of the development strategy for an assigned clinical program. As the medical expert for the asset they will ensure that the program is delivered incorporating current medical and current best clinical practice and the evolving healthcare systems and science. They will also ensure that the program is designed using the most recent knowledge and medical scientific opinion ensuring, where feasible that recent innovation and advances are appropriately incorporated.

• May have line management responsibility
• May take leadership of a clinical development program as Clinical Development Leader

Who you will work with

Cross-functional matrix teams, and experienced, dynamic and diverse Clinical Development Physicians and Scientists within GCD.

What you'll do

• Is responsible for correct and current medical/scientific information on the asset, mode of action, disease and patient population, therapeutic field and relevant competitor insights for the assigned programs/study(ies) and ensures its incorporation into the Clinical Development Plan (CDP) and all related documents.
• Is responsible to provide ongoing training on most current medical/scientific knowledge to all members of the Development team and sub-teams on topics related to the therapeutic field in question.
• Is responsible for the medical/scientific integrity of clinical development programs and all related documents (e.g. TCLP, protocols, clinical trial reports, not exhaustive).
• Is responsible to establish effective relationships with the investigator and study site(s) (may include on-site visits as appropriate) as primary UCB medical contact person
• Is responsible for ongoing medical monitoring for assigned study(ies) and the benefit risk assessment of the program (in particular subject inclusion/exclusion and withdrawal assessment and documentation).
• Leads the organisation of and interaction with Data and Safety Review Boards
• Is responsible for review, medical input into and/or finalization of all study documents such as the statistical analysis plan (SAP), informed consent forms (ICF), protocol deviations data management (PDDM), specification of protocol deviations (SPD), database cleaning strategy (e.g. Data Cleaning Plan)
• Is responsible for adequate medical analyses and definitions of analysis populations, interpretation and reporting of study efficacy and safety results.
• Is responsible to develop and provide the medical/scientific content of documents prepared for regulatory authority interactions (Briefing documents, Common Technical Documents, Integrated Efficacy/Safety summaries, Clinical Overview) and to review regulatory documents for medical/scientific accuracy and integrity.
• Is responsible to establish and maintain an impactful internal and external stakeholder network, in particular including contacts worldwide with experts in the disease area, including KOL, health agencies and professional societies, patients' groups, patients and carers ensuring relevant population diversity and patient voice/ PCOR is integrated into the development program.
• Is responsible as global medical/scientific spokesperson regarding the development program towards the internal and external community, including scientific/medical communities, regulatory and governmental agencies.
• Is responsible to represent UCB by speaking at conferences and symposia
• Is responsible to provide medical/scientific strategic input into lifecycle management/ISEG strategy for the assigned asset, publications/presentations.
• Is responsible to provide Business Development with medical/scientific evaluation of licensing-in compounds.
• Global travel will be required.

Interested? For this role we're looking for the following education, experience and skills

• Medical Degree Required
• Board certification or other higher medical and academic qualification
• Have a minimum of 5 years of experience in the biopharmaceutical industry, with at least 3 years in clinical development.
• Technical: Able to strategically contribute to the design, development and conduct of clinical programs and studies and ensure the medical integrity and feasibility of a clinical development program optimized for quality, speed and cost, in accordance with TPVP.
• Technical: Excellent working knowledge and proven record of all medical aspects of the global clinical development process.
• Leadership: Ability to actively contribute to high performing teams, influence and manage internal stakeholder relationships at all levels in the organization.
• Leadership: Excellent communication skills demonstrating clear and articulate verbal, written and presentation skills with excellent language skills to ensure credible communication with the external medical and scientific community and for internal communication.
• Entrepreneurial and Innovation: Ability to apply most current medical expert knowledge to optimize the design and conduct of clinical programs by application of innovative, state of the art approaches to clinical management, evidence generation, use of technology, .
• Proficient and positive attitude toward using digital tools

*This position's reasonably anticipated base salary range is $177,200-$232,600 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills and experience, among other

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

RANDATUCB

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.