Lead Clinical Research Scientist -- Respiratory
Proclinical is currently recruiting for a Lead Clinical Research Scientist for a multinational pharmaceutical company located in Marietta, PA. Successful candidate will support the delivery of clinical development excellence in compliance with internal policies and external regulations by providing scientific/medical expertise on specific category/sub-category innovation project strategies.
- Responsible clinical development expert leadership and/ or input within category/ sub-category team(s) ensuring that the clinical research studies in Respiratory are aligned and support category innovation strategies approved by senior management.
- With oversight from Category Clinical Research/ Development Director be responsible for liaising with Category/sub-category Medical Affairs leads and other stakeholders to input and implement medical strategy and then translate to an associated clinical development/ claim support programs for consumer Respiratory healthcare studies.
- Develop and execute research plans and studies using established scientific methods and protocols (e.g. experiential research, Respiratory health-related quality of life, in vivo/ in-vitro Respiratory clinical studies).
- Develop, adapt and validate test methods and procedures within the Respiratory healthcare
- Contribute to the design, conduct and scientific merit of clinical studies evaluating the in vivo performance of Respiratory healthcare products where clinical testing is required. Organize clinical testing in support of clinical department functions.
- Partner with other CDMA and, if required, R&D functions to develop innovative study designs/ methodologies to enable new and competitive claims to be made on Consumer Healthcare Respiratory healthcare products.
- Ensuring clinical trial design, results reporting, and publication are undertaken in compliance with external e.g. GCP, internal Medical Governance and other internal policy requirements.
- In collaboration with Clinical Operations evaluate external test sites for study / test capabilities.
- Deliver expert technical knowledge and leadership to the Business in clinical development activities helping to ensure best practice and achievement of business objectives based on science and values within the Respiratory healthcare space.
- Responsible for conducting clinical due diligence for external opportunities
- Support regulatory activities (e.g. FDA positioning, 510k applications).
- Keep up to date with relevant therapeutic/ scientific literature and provide clinical expertise to facilitate preparation of clinical development and therapeutic strategies for the Respiratory Healthcare category.
Skills and Requirements:
- Higher Degree (Pharm D, PhD or MD highly preferred)
- MSc level degree required
- Medical or similar Clinical Science
- Externally facing role, Technical Expertise
- Medical writing experience including protocols, clinical study reports, clinical sections of INDs, NDAs, CERs, COs, Safety reports and global regulatory marketing applications
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.