- Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety teams
- Sits as a member of the MoonLake Clinical Development Team for named projects and provides advice, guidance, and clinical development expertise on medical related topics to the development project and clinical trial teams
- Works cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. participate in study start up, and cross-functional team meetings, perform data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training etc.).
- Provides medical input to operational team, including review of documents and plans, e.g CRFs, medical monitoring plans, laboratory manuals, deviation management plans etc.
- Performs medical data review to maintain oversight of emerging efficacy and safety profile as well as potential quality issues for designated trials.
- Works closely with the Drug Safety Officer to support overall surveillance of safety activities related to MoonLake clinical development programmes including, single case medical review, aggregate reporting, signal detection and evaluation, safety related activities associated with regulatory filings, benefit risk assessment and safety risk assessment.
- Works closely with the Drug Safety Officer and CRO teams to organize and support DMC/DSMBs for MoonLake trials/programmes
- Drives development of clinical sections of trial and program level regulatory documents (e.g., protocols, Investigator's Brochure updates, Clinical Study Reports, and responses to Health Authorities).
- May also support clinical development planning activities, working with other functional groups to provide medical input to programme design
- Minimum of 5 years of professional experience of clinical research within a biotech or pharmaceutical company ideally in Dermatology/Rheumatology/Inflammatory diseases.
- Experience of regulatory drug development requirements in US and EU markets. Previous experience of interactions with national supervisory authorities (e.g. EMA, FDA) is a plus
- Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety teams
- Sits as a member of the MoonLake Clinical Development Team for named projects and provides advice, guidance, and clinical development expertise on medical related topics to the development project and clinical trial teams
- Works cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. participate in study start up, and cross-functional team meetings, perform data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training etc.).
- Provides medical input to operational team, including review of documents and plans, e.g CRFs, medical monitoring plans, laboratory manuals, deviation management plans etc.
- Performs medical data review to maintain oversight of emerging efficacy and safety profile as well as potential quality issues for designated trials.
- Works closely with the Drug Safety Officer to support overall surveillance of safety activities related to MoonLake clinical development programmes including, single case medical review, aggregate reporting, signal detection and evaluation, safety related activities associated with regulatory filings, benefit risk assessment and safety risk assessment.
- Works closely with the Drug Safety Officer and CRO teams to organize and support DMC/DSMBs for MoonLake trials/programmes
- Drives development of clinical sections of trial and program level regulatory documents (e.g., protocols, Investigator's Brochure updates, Clinical Study Reports, and responses to Health Authorities).
- May also support clinical development planning activities, working with other functional groups to provide medical input to programme design
- Minimum of 5 years of professional experience of clinical research within a biotech or pharmaceutical company ideally in Dermatology/Rheumatology/Inflammatory diseases.
- Experience of regulatory drug development requirements in US and EU markets. Previous experience of interactions with national supervisory authorities (e.g. EMA, FDA) is a plus
- Thorough knowledge of Good Clinical Practice guidance and regulations for drug development.
- Demonstrated ability to independently evaluate, interpret and present complex scientific data
- Demonstrated ability to critically evaluate complex drug development programs
- Demonstrated ability to work within a multi-disciplinary team of peers and outside experts
- Good organizational and planning talent with excellent communication skills (written or spoken).
- 2 days a week in our brand new Cambridge or Porto Office(s)
-
Medical Director
1 week ago
Great Ormond Street Hospital NHS Foundation Trust London, United Kingdom**Medical Director - North Thames Genomic Medicine Service (GMS)** · The North Thames Genomic Medicine Service (GMS) has an exciting opportunity for a Senior Medical Consultant in Genomics, either on its own or in conjunction with expertise in a different discipline, to join our ...
-
Medical Director
3 days ago
Vitality Corporate Services Limited London, United KingdomAbout The Role · 12 Month Contract · Team – Clinical Leadership Team · Working Pattern - Hybrid – 2 days per week in the Vitality London Office. Part time, 24 hours per week. · Top 3 skills needed for this role:Health Insurance expertise · Healthcare pathways · Healthcare cost m ...
-
Associate Medical Director
3 days ago
X4 Group London, United KingdomA renowned, well established agency is currently looking for an Associate Medical Director to join their team · **The company** · They are a hugely successful, friendly agency who are large at first look, but operate as lots of smaller, independent agencies, all with different sp ...
-
Associate Medical Director
1 week ago
Circle Health Group London, United Kingdom**Circle Health Group are proud to be recognised as one of the UK's 25 best big companies to work for and one of the 10 best companies to work for in the health and social care sector.** · **We have an opportunity for a Associate Medical Director to join our team.** · **This is a ...
-
Associate Medical Director, Medical Affairs
4 days ago
Worldwide Clinical Trials United Kingdom**Requisition Number**7731** · **Employment Type**:Regular** · **Who we are** · Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that a ...
-
Executive Assistant to Medical Director
1 day ago
Universitätsklinikum Freiburg United KingdomDie Klinik für Innere Medizin II, Schwerpunkt Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie, sucht zum nächstmöglichen Zeitpunkt eine*n erfahrene*n · Die Schwerpunkte unserer Klinik liegen in der interdisziplinären Diagnostik und Therapie von Erkrankungen der ...
-
Associate Director, International Medical
1 week ago
Apellis London, United Kingdom**Position**:Associate Director, International Medical Communications · **Reports to**:Director of Medical Affairs · **Location**: Zug, Switzerland, or remote within the UK and Europe · **Position Summary**: · The International Associate Director of Medical Communications in Medi ...
-
Central London Community Health Trust London, United KingdomAssociate Medical Director (2PAs) Associate Medical Directors (AMDs) are Senior Medical leads that are accountable for a significant but focused area of the medical leadership portfolio. In conjunction with the Medical Directorate leadership team you will lead and direct your rel ...
-
NHS England London, United KingdomThis is a fantastic opportunity to join the regional senior management team with a substantive amount of your time spent in the London Region. The post holder will provide professional and clinical leadership to regional and local networks of clinicians to support and drive chang ...
-
Associate Medical Director,clinical Science
6 hours ago
BioMarin London, United KingdomBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom ar ...
-
Medical Director
4 days ago
MENTUS RECRUITMENT LTD Ilford, United Kingdom Full time· Mentus Recruitment are proud to be working in partnership with a Leading private mental health provider. · We have an exciting opportunity for an experienced Consultant Psychiatrist or Medical Director to join an established hospital based in East London. The successful clini ...
-
Medical Director
2 days ago
Clinical Professionals Limited London, United KingdomReference Number: JO · Medical Director · Rate: Negotiable · Job Type: Contract · Location: Central London / West End · Medical Director – Fixed Term Contract – 12 Months – London · A global pharmaceutical organisation specialising in Neurology and Oncology is now in need o ...
-
Only Medics London, United KingdomAssociate Medical Director, Immunology · Job Type: Permanent · Associate Medical Director, Immunology · Benefits: Car allowance, bonus, pension, healthcare, LTIs · We're excited to be working alongside our client who brings life changing medicines to millions of patients worl ...
-
Medical Director
1 week ago
Blackfield Associates London, United KingdomJob Description Medical Director, EU, Oncology · Blackfield Associates are currently partnering with a Mid-Sized Pharmaceutical Organization in the search for a Medical Director for Europe to work across their Oncology Portfolio. · Lead the development and execution of the EU m ...
-
Medical Director
1 week ago
Blackfield Associates London, United KingdomMedical Director, EU, Oncology · Blackfield Associates are currently partnering with a Mid-Sized Pharmaceutical Organization in the search for a Medical Director for Europe to work across their Oncology Portfolio. · Lead the development and execution of the EU medical affairs s ...
-
Medical Director
5 hours ago
Only Medics London, United KingdomReference Number: JO · Medical Director – Medical Affairs & Clinical Dev · Rate: Negotiable · Job Type: Permanent · Location: Central London / West End · Medical Director – Medical Affairs and Clinical Development · Location: London · Salary: Competitive · Benefits: bonus ...
-
Medical Director
3 days ago
Carrot Pharma Recruitment United KingdomMedical Director – IME / CME – Global Medical Education Company – East Coast USA -Remote · The Company · An internationally recognised company that delivers evidence-based medical education to global healthcare professionals. · Expertise in needs assessment, grant writing, conten ...
-
Medical Director
2 weeks ago
Parexel International United KingdomParexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, ou ...
-
Medical Director
1 week ago
Clinical Professionals Limited England, United KingdomReference Number: JO · Medical Director · Rate: Negotiable · Job Type: Permanent · Location: Oxford · Medical Director – £1000 Per Day – Oxford · A cutting-edge clinical stage biotech specialising in Oncology is now in need of a Medical Director to come on board and provide ...
-
Medical Director
1 week ago
argenx SE United KingdomUK Medical Director, Medical Affairs page is loaded UK Medical Director, Medical Affairs · Apply locations UK - Remote time type Full time posted on Posted 30+ Days Ago job requisition id REQ-2267 Join argenx · Next to a competitive salary with extensive benefits, we offer you ...
Medical Director - United Kingdom - Moonlake
Description
The Medical Director will serve as medical lead for MoonLake's clinical development programs and as medical advisor to the Executive team and all internal functions regarding clinical development activities.
Key Responsibilities:Your profile
Education: Medical Degree and/or Degree in Sciences
Experience:
Job Purpose
The Medical Director will serve as medical lead for MoonLake's clinical development programs and as medical advisor to the Executive team and all internal functions regarding clinical development activities.
Key Responsibilities:Your profile
Education: Medical Degree and/or Degree in Sciences
Experience:
Why us?
An exciting job opportunity awaits you
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team. What we offer: Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment. Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare. Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team. Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills. Our Core Values We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence: We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always. We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other. We unlock value: We aspire to create long-term value for investors and communities.Firstname *
Lastname *
E-Mail *
Phone
Available from
CV *
Max. 20 MB.
Other files
Max. 20 MB per file.
I hereby confirm that I have read and understood the Data privacy statement on this page: *
#J-18808-Ljbffr