Medical Director

4 weeks ago

Cambridge, United Kingdom MoonLake Immunotherapeutics Full time
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:

  • 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
Your profile

Education: Medical Degree and/or Degree in Sciences  
Experience: 

  • 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

Skills/knowledge/behavioural competencies:
  • 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).
Work Location:
  • 2 days a week in our brand new Cambridge or Porto Office(s)
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.

About us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.

Further information is available at www.moonlaketx.com

  • Medical Director

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    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: Provides medical oversight of outsourced study conduct including interactions with CRO medical and drug safety...

  • Senior Medical Director

    4 weeks ago

    Cambridge, United Kingdom Relay Therapeutics Full time

    As a Senior Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration. Specifically, you will collaborate with senior medical staff to drive clinical strategy, clinical trial design, and execution. Working cross-functionally with clinical project management, regulatory affairs, clinical...

  • Senior Medical Director

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full time

    Senior Medical Director, Drug Safety and Pharmacovigilance page is loaded Senior Medical Director, Drug Safety and Pharmacovigilance Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R976 Why Join Intellia? Beyond our science, we live our four core values: We have a single-minded determination to excel...

  • Sales Director

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Cpl Full time

    Sales DirectorCambridgeTravel: Approximately 50% of the time – globally. One day per week in the office is also expected.A high-level opportunity for an experienced Sales Director to join a global leader in the field of scintillation technologies, with medical, security and industrial specialisms.Reporting directly into the Managing Director of this...

  • Graduate Electronics Engineer

    1 month ago

    Cambridge, United Kingdom Newton Colmore Consulting Ltd Full time

    Graduate Electronics Engineer - Medical Devices A growing Medical Devices company are currently looking for a number of Graduate Electronics Engineers to be based in their labs in Cambridge, ideally looking for someone to start in Summer 2023. Also, if you have moved into a role for the last year or two and have not had the support expected, we could still...

  • Consultant in Medical Oncology

    1 month ago

    Cambridge, United Kingdom Cambridge University Hospitals NHS Foundation Trust Full time

    Applications are invited for the post of Consultant in Medical Oncology (Breast Cancer CUH / HPB NWAFT) to join our Cancer Directorate at both Addenbrooke’s and Hinchingbrooke Hospital. This is a (10PA) full-time, substantive post in Breast based at both sites and HPB at Hinchingbrooke Hospital. The duties of this post include - MDTs in breast and HPB...

  • Associate Director \/ Director

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Lofthouse Group Full time

    Director / Partner | Architecture and Design | Cambridge An exciting opportunity for an experienced leader in architecture, to take up a key role in the Cambridge office of a highly respected, world-renowned architectural practice. Their project portfolio is diverse and includes civic buildings, hotels, residential schemes, commercial projects and...

  • Associate Director \/ Director

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom Lofthouse Group Full time

    Job Description Director / Partner | Architecture and Design | Cambridge An exciting opportunity for an experienced leader in architecture, to take up a key role in the Cambridge office of a highly respected, world-renowned architectural practice. Their project portfolio is diverse and includes civic buildings, hotels, residential schemes, commercial...

  • Consultant in Medical Haematology

    4 weeks ago

    Cambridge, United Kingdom Cambridge University Hospitals Full time

    **Main area** - Medical Haematology**Grade** - Consultant**Contract** - Permanent**Hours** - 10 sessions per week (Full-Time)**Job ref** - 180-CON-4779**Employer** - Cambridge University Hospitals NHS Foundation Trust**Employer type** - NHS**Site** - Addenbrooke's Hospital**Town** - Cambridge**Salary** - £93,666 - £126,281 per annum pro-rata**Salary...

  • Managing Director

    11 hours ago

    Cambridge, United Kingdom PER International Full time

    Job DescriptionHave you ever successfully launched and grown a new business unit in a completely new region? If so, you might be the perfect fit for this role!OVERVIEWBased near Chicago, USA, this company manufactures high-value precision assemblies for defense, aerospace, semiconductor, and medical industries. With 350 employees and annual revenue exceeding...

  • Managing Director

    12 hours ago

    Cambridge, United Kingdom PER International Full time

    Have you ever successfully launched and grown a new business unit in a completely new region? If so, you might be the perfect fit for this role!OVERVIEWBased near Chicago, USA, this company manufactures high-value precision assemblies for defense, aerospace, semiconductor, and medical industries. With 350 employees and annual revenue exceeding $100 million,...

  • Managing Director

    2 days ago

    Cambridge, United Kingdom PER International Full time

    Have you ever successfully launched and grown a new business unit in a completely new region? If so, you might be the perfect fit for this role!OVERVIEWBased near Chicago, USA, this company manufactures high-value precision assemblies for defense, aerospace, semiconductor, and medical industries. With 350 employees and annual revenue exceeding $100 million,...

  • Managing Director

    2 days ago

    Cambridge, United Kingdom PER International Full time

    Have you ever successfully launched and grown a new business unit in a completely new region? If so, you might be the perfect fit for this role!OVERVIEWBased near Chicago, USA, this company manufactures high-value precision assemblies for defense, aerospace, semiconductor, and medical industries. With 350 employees and annual revenue exceeding $100 million,...

  • Managing Director

    2 days ago

    Cambridge, United Kingdom PER International Full time

    Have you ever successfully launched and grown a new business unit in a completely new region? If so, you might be the perfect fit for this role! OVERVIEW Based near Chicago, USA, this company manufactures high-value precision assemblies for defense, aerospace, semiconductor, and medical industries. With 350 employees and annual revenue exceeding $100...

  • Director, Genetic Disease Patient Advocacy

    2 weeks ago

    Cambridge, United Kingdom Relay Therapeutics Full time

    The Opportunity: As Director, Genetic Disease Patient Advocacy, you will be responsible for building and maintaining relationships with the patient community and patient advocacy organizations across Relay Tx’s emerging genetic disease portfolio, for ensuring that the needs and insights from these relationships are reflected in internal decision-making...

  • Senior Postgraduate Administrator

    4 weeks ago

    Cambridge, United Kingdom Medical Research Council Full time

    **Details**: **Reference number**: - 308273**Salary**: - £32,005 - £35,143- per annum**Job grade**: - Other**Contract type**: - Permanent**Business area**: - MRC - Administration**Type of role**: - Administration / Corporate Support**Working pattern**: - Full-time**Number of jobs available**: - 1Contents Location About the...

  • Senior Director – Digital Acceleration

    2 days ago

    Cambridge, United Kingdom AstraZeneca Full time

    Introduction to role: Are you ready to transform the lives of people living with cancer by leading in patient experience and care? As a Senior Director for Digital Acceleration, you will be responsible for defining and executing digital product strategy and accountable for delivery of all tactics led by Digital Programme Leads. You will own the successful...

  • Senior Planning Associate Director

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    Associate Director - Regulatory Affairs page is loaded Associate Director - Regulatory Affairs Apply locations United Kingdom - Cambridge time type Full time posted on Posted 17 Days Ago job requisition id R0040532 For Current Gilead Employees and Contractors: For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and...

  • Specialty Doctor in Adult Psychiatry

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Triple West Medical Full time

    We have been assigned by one of the UK's more prestigious NHS Trusts to help them recruit a Specialty Doctor in Child and Adolescent Psychiatry on either a Substantive or an NHS Fixed Term basis for 12 months to join their successful department. Our client are is a health & social care organisation dedicated to providing high quality care with compassion...

  • Director, Rare Genetic Disease Patient Advocacy

    1 hour ago

    Cambridge, United Kingdom Relay Therapeutics Full time

    The Opportunity: As Director, Genetic Disease Patient Advocacy, you will be responsible for building and maintaining relationships with the patient community and patient advocacy organizations across Relay Tx’s emerging genetic disease portfolio, for ensuring that the needs and insights from these relationships are reflected in internal decision-making...