For our client, Johnson and Johnson with a branch in Allschwil, we are currently looking for a
Regional R&D Medical Manager
Start date: 01.11.2021
Duration: 1 year
Location: Allschwil / home office
The focus of this position is to support engagement with investigators involved in Janssen global R&D clinical studies and facilitate their understanding of study protocols.
The incumbent is responsible for the compliance of the assigned clinical study(ies) with department, company and regulatory standards and procedures.
- Core member of the Cross Functional Trial Team for the allocated studies.
2. Responsible for engagement with study investigators involved in clinical studies within their allocated Region, in close collaboration with the Global/Local operational team (GTL, CTM, SM, LTM) and the Global clinical team (SRS, SRP). May support other Regions as required.
3. Establish a collaborative medical/scientific connection with investigators, through regular on-site and/or remote visits, to facilitate 2-way communication and increase site engagement and motivation.
4. Throughout development of own network, identify potential new investigators within the assigned Region to be considered for referral, participation in new or existing trials and/or engagement in advisory committees.
5. Provide support to investigators for any medical/protocol question. Identify any potential site hurdle (e.g. protocol clarifications, medical/scientific questions, operational challenges, resources constraints…) and advise sites on potential study conduct failures (e.g. best practices sharing for screening failures minimization, patient recruitment and retention optimization…).
6. Develop an in-depth knowledge of the allocated sites status (e.g. recruitment status, patient identification and/or referral process in place, protocol deviations, SAEs …).
7. Maintain clinical and technical expertise in the therapeutic area, competitor's products and clinical trials (e.g. scientific literature review, congress attendance…).
8. Ensure close collaboration with internal local stakeholders (operational and medical teams) within the assigned countries.
9. Share insights gathered from sites and discuss possible protocol enhancement with the respective Global clinical team.
10. Manage trainings for local clinical teams on disease area and/or compound training, as required.
11. As requested, participate into cross functional teams for evaluation of new product ideas, implementation of business strategies, improvement of processes, etc.
Cross-functional Trial Team: GCDO Trial Leader, Clinical Scientists (i.e. Study Responsible Scientist), Clinical Trial/ Project Physicians (i.e. Study Responsible Physician)
Contacts Inside the Company: Global Clinical Development Operations (GTL, CTM, SM, LTM), Global Clinical Science (e.g. Clinical Scientists/Study Responsible Scientists, Clinical Trial/ Project Physicians/ Study Responsible Physician…), Global Medical Safety, R&D Project Management Organization, Quality Management, Quantitative Sciences, Regulatory, Trial Supply Management, other departments as needed.
Contacts Outside the Company: investigators, academic thought leaders, vendors and CRO contacts as appropriate.
Required qualifications and experience
1. MD, PhD, PharmD, DVM, MSc or equivalent degree in Biological Sciences required
2. At least 5 years experience in Pharmaceutical Industry; Prior experience in cardiac and/or pulmonary disease area is a plus.
3. Sound knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines. Hands-on experience on conducting clinical trials is a plus.
4. Prior experience of working in a matrix organization including interactions with all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external service providers, etc.) and external customers.
5. Proven leadership skills.
6. Demonstrated analytical skills.
7. Experience in driving business process improvement projects desirable.
8. Excellent computer systems and software skills.
9. Excellent English, other languages advantageous.
1. Good organizational skills, good written and verbal communication skills, able to work as part of a team and independently
2. Good independent time management skills
3. Ability to plan and track deliverables and timelines
4. Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
5. Detail oriented
Franck Maerky (+41 61 270 80 17) is happy to get your application via one PDF