Senior Medical Director...

Job Purpose

The Senior Medical Director will report directly to the Chief Medical Officer. The Senior Medical Director has the responsibility for driving the medical content of the development plan.
The Senior Medical Director provides medical oversight across the sonelokimab clinical development plan. The Senior Medical Director is a medical advisor to all internal functions regarding clinical development related matters and may deputise for the Chief Medical Officer when asked.

Major Accountabilities:

• Become a content expert for the molecule and disease area with the organisation and externally.
  
• Provide clinical, medical and scientific leadership within the medical and broader multifunctional clinical development group.
  
• Assures GCP, Clinical Operating Guidelines and Standard Operating Procedures are carefully followed.
  
• Is a core member of the Drug Safety Committee and Clinical Development cross functional leadership teams.
  
• Deputises on behalf of the Chief Medical Officer when required.
  
• Represents the main interface between the Medical function with Clinical Operations/Development for project related activities in delivering the overall plan.
  
• Works with the study Medical Directors and PV Director in ensuring Medical related study responsibilities are met.
  
• Provides support/guidance to the study Medical team and PV Director as required.
  
• Inputs into the design and development of protocols.
  
• Directly contribute to regulatory documentation and attend meetings with the various HA as appropriate.
  
• Provides clinical oversight across all relevant studies and programs working closely with the appointed CRO.
  
• Works with the CRO appointed medial monitors to ensure that agreed plans, processes and reporting are achieved and escalates in line with the agreed process in the event issues arise.
  
• Selects suitable clinical consultants and experts in conjunction with Medical Affairs.
  
• Plans, schedules and performs, on an ongoing basis, an evaluation of project related clinical data and sets up and reviews with the team the safety data to detect safety signals.
  
• Ensures correct data interpretation and reporting, including interim analysis and Clinical Study Reports (CSR).
  
• Has overall accountability for the Benefit: Risk ratio of the program [co-responsibility with PV Director and Regulatory]. Makes recommendations to the Drug Safety Committee.
  
• Supports the Safety/ Pharmacovigilance group in developing the risk management plan.
  
• Provides expert input to the medical affairs and commercial team as needed.
  
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
  
• Where applicable accountable for performance management and the career development plans of his/her reports and actively ensures that they receive appropriate management and technical support and training, including required training in SOPs.
  
• Selects, interviews and makes hiring recommendations to the Chief Medical Officer in the reporting area.
  
  Your profile
  
  Education:
  
  
• Qualified Physician (GMC or GMC permissible).
  
  Experience:
  
  
• Medical degree with GMC registration or equivalent.
  
• ≥10 years’ experience in Clinical Development with demonstrable track record in Phase 3 drug development and regulatory interactions.
  
• Excellent knowledge of FDA/EMA requirements, GCP, ICH guidelines and pharmaceutical clinical development.
  
• Experience of Health Authority interactions and regulatory submissions including NDA/BLA.
  
• Demonstrated capacity to lead, plan strategically, achieve goals on time, and communicate effectively.
  
• A highly effective communicator able to foster relationship building, including cross- functional teams, and external relationships with vendors (eg. CRO).
  
• Track record of successful cross functional matrix working in a collaborative team environment where results are achieved through influence and incorporating multiple diverse points of view.
  
• Proven understanding of GCP, specifically from a daily operational perspective.
  
  Skills/knowledge/behavioural competencies:
  
  
• A clear communicator with the ability to think both strategically and tactically in developing and delivering an integrated development plan on time and with budgetary awareness.
  
• Demonstratable knowledge of pharmacovigilance.
  
• Demonstrated ability to evaluate, interpret and present complex clinical data.
  
• Demonstrated ability to work within a multi-disciplinary team of peers and outside experts.
  
• Demonstratable ability to make decisions and recommendations.
  
• Good organizational and planning talent with excellent communication skills (written or spoken).
  
• Excellent knowledge of the competitive environment for drugs in the Dermatology/Rheumatology space.
  
• Must have a thorough knowledge of clinical development concepts, practices, and GCP and ICH Guidelines.
  
• Must have excellent interpersonal skills; have proven skills as an effective team player who can engender credibility and confidence within and outside the company.
  
• Is science- and data-driven.
  
  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.
  
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