!*RWE Generation Senior Manager - Fully homebased - Global Bio-Pharmaceutical!* - #1674840

!*RWE Generation Senior Manager - Fully homebased - Global Bio-Pharmaceutical!*

Location: Homebased in the UK

FTE: Full time - 12 month contract with the view to extend

Start date: ASAP

Rate: Very good package

Job Description

Planet Pharma are working with a leading biopharmaceutical company dedicated to researching, developing, and bringing to market transformative medicines that address unmet medical needs. Their mission centers on enhancing patient care worldwide by innovating new treatments and experimental drug candidates. Their work focuses on therapeutic areas such as HIV/AIDS, hepatitis, severe respiratory diseases, cardiovascular and metabolic disorders, cancer, and inflammatory conditions..

Real-World Evidence Generation involves developing and conducting observational research studies. The (Senior) Manager collaborates across teams, providing expertise and practical support for implementing evidence generation throughout the region. This role reports to the Director, Real-World Evidence ACE Lead.

Responsibilities:

• Develop and execute studies on incidence/prevalence, burden of illness, and natural history of disease for business and early development indications.


• Provide tactical support for cross-functional RWE development, including registries and assessments of burden of illness/natural history of disease for regulators, payers, and clinicians.


• Offer strategic and practical support for designing RWE historical controls and methods.


• Adapt performance metrics and dashboards for RWE projects within their therapeutic area.


• Communicate research methods and results effectively to diverse audiences.


• Manage expectations of internal and external stakeholders regarding research objectives and implementation.


• Write protocols, SAPs, clinical study reports, and review study-related documents.


• Provide clinical expertise and support for regulatory filings and responses to regulatory authority inquiries related to IND submissions, clinical trial applications, or filing procedures.


• Interact with clinical investigators and thought leaders.


• Lead and collaborate with external stakeholders (e.g., medical experts, advisory boards, patient advocacy groups) and internal teams (e.g., Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, Commercial).

Requirements:

• Scientific degree (i.e. MSc, PhD, MD or PharmD) and experience in biostatistics, epidemiology, health economics or outcomes research experience


• Experience in Hematology and/or Oncology


• Experience conducting/reviewing systematic literature reviews


• Advanced knowledge in observational research design


• Strong working knowledge of the Microsoft Office Suite (Word, PowerPoint, Excel)


• Able to conduct analyses using statistical software such as R, SAS, SPSS or Stata

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency.

We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.