Senior Medical Director
Jobbeschreibung
Basel, Basel-Stadt, Schweiz
Mirum Pharmaceuticals
03.05.2024
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MISSIONMirum Pharmaceuticals is a biopharmaceutical company dedicated
to transforming the treatment of rare diseases affecting children and
adults. Propelled by our passion for patients and their families,
we’re focused on turning possibilities into realities. Using data and
meaningful evidence, our goal is to transform scientific discoveries
into therapies that are poised to positively impact the treatment of
rare diseases. We are collaborative, creative, and experienced
professionals and we’re looking to augment our team with other
individuals who embody our values: care, be real, get it done, and
have fun, seriously. Learn more about our work, our culture, and what
it’s like to be a part of our team: .POSITION SUMMARY The Senior
Medical Director will join the Clinical Development group and will be
responsible for all clinical trial related activities in all stages of
clinical development in a cross-functional team of internal and
external experts, investigators and government agencies. Activities
include but are not limited to protocol development, support study
startup, oversight of trial execution, recruitment, ongoing clinical
development management and closeout as appropriate. Compliance with
internal processes, GCP/ICH and regulatory requirements, study and
data monitoring, data analysis, are required. Participation in health
authority meetings and regulatory filing activities are also part of
this role. The Senior Medical Director operates in collaboration with
other functions including internal Safety and Clinical Operations
teams.JOB FUNCTIONS/RESPONSIBILITIES Leadership and management of all
aspects of complex, global development clinical study program(s), from
phase 1 through post-commercialization.Primary point of contact for
medical inquiries from sites, CRO and site monitors; answer or triage
questions as appropriate integration of clinical/regulatory strategy
into global product development strategy.Primary liaison for internal
Clinical Operations for site selection, site start-up activities,
study management and closeout activities, etc.Support the creation of
and/or review of clinical slides for internal and external meetings
(i.e. Investigator Meetings, SIVs, Advisory Boards, etc.)Assist in
authoring key clinical study documents, including Protocols, Clinical
Study Reports, Investigator Brochures, Regulatory Authority briefing
books, Development Safety Update Reports etc.Responsible for medical
monitoring of efficacy and safety clinical trial data.Strategic input
on the overall development plan, internal and external evaluation of
new indications and studies.Oversight of medical aspects of compliance
of and inspection readiness in completed, ongoing and starting
clinical trials.Collaboration in the analysis and writing of
scientific publications/presentations.Works closely with other
functions, in particular with Safety function and Clinical
Operations.Co-leads Study Management Team with Clinical Operations
lead.QUALIFICATIONSEducation/Experience: MD, with a minimum of 5
years.Experience in Liver or rare disease preferred.Knowledge and
understanding of regulatory requirements for product approval and
compliance in US and Europe.Knowledge, Skills and Abilities:
Demonstrated accountability for delivery on complex development
plans.Leadership in clinical development programs and
multidisciplinary trial teams.Experience with basic statistical
principles and techniques of data analysis, interpretation and
clinical relevance.Ability to understand and communicate risks, as
well as develop and execute contingency plans.Experience presenting
data to regulatory agencies and advisory committees.Ability to think
creatively and develop and execute in a fast-paced environment.Detail
oriented with exceptional organizational skills.Effective communicator
with strong verbal and written skills.Ability to identify issues,
analyze situations and provide effective solutions.Solid understanding
of the clinical development process.Knowledge of applicable
regulatory.Willingness and ability to travel domestically and
internationally is required; it is anticipated that this will be 30%
of work time.Mirum Pharmaceuticals is committed to Equal Employment
Opportunity (EEO) and to compliance with all Federal, State and Local
laws that prohibit employment discrimination on the basis of race,
age, national origin, ethnicity, religion, gender, gender identity,
pregnancy, marital status, sexual orientation, citizenship, genetic
disposition or characteristics, disability, veteran’s status or any
other classification protected by applicable State/Federal/Local
laws.Mirum Pharmaceuticals provides reasonable accommodation for
qualified individuals with disabilities and disabled veterans in job
application procedures.