Service Medical Director leading Anaesthesia and Perioperative Medicine at Monash Health. Collaborating across departments to ensure effective healthcare delivery and patient safety standards.
About the role
- Leading the direction, planning, execution of clinical trials and interpretation of clinical data
- Establishing scientific methods for design, implementation of clinical protocols, and ensuring trial subject safety
- Leading clinical trials, phases I - IV, for company products under development
- Building and managing the clinical research scientist team supporting clinical trials and overseeing CROs and other vendors
- Building reliable relationship with clinical investigators, discussing trial design, leading investigator’s meetings and advisory boards
- Monitoring safety and reporting adverse events
- Coordinating and developing information for reports submitted to the FDA and other health authorities and representing the Company at different forums
- Monitoring adherence to protocols and determining study completion
- Reviewing clinical data and leading/authoring reports and study related documents, such as IBs, study protocols, publications and regulatory filings including briefing documents, reports, and IND/BLA submissions
- Evaluating products for in/out licensing
- Participating in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs to clinical evaluation
- Staying abreast on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result
- Provide medical review, assessment and interpretation of clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
- Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws
Requirements
- MD degree or equivalent
- Hematology expertise
- Prior experience in cell therapy products
- Experience in clinical trial planning and implementation
- Experience or exposure to FDA/EMA/PMDA/ or other regulatory agencies interactions
- Excellent verbal and written communication skills
- Contributing to the Clinical Strategy and Clinical Development Plans for the Company’s assets
- Proven ability to work independently, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environment
- Strong organizational, time management, communication, and interpersonal skills
- Capable of managing multiple diverse projects simultaneously
Benefits
- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Generous paid vacation time, in addition to company-observed holidays
- Excellent medical, dental, and vision insurance
- 401(k) retirement savings plan, which includes matching employer contributions
- Employee stock purchase plan (ESPP)
- Tuition reimbursement program
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
AS
Senior Medical Director providing medical and scientific input for early phase clinical development in Rheumatology. Collaborating with cross - functional teams and external partners to deliver innovative clinical studies.
Executive Medical Director/SERM Head driving clinical safety and pharmacovigilance strategy for Oncology. Leading global teams to ensure highest standards of patient safety with focus on regulatory compliance.
Medical Director overseeing clinical, legal, and compliance standards at Oli at Home. Collaborating with leadership, supervising providers, and ensuring quality across markets.
EH
Elevance HealthMedical Director
Medical Director overseeing physical and behavioral health medical services for Elevance Health. Ensuring cost - effective care and developing quality improvement programs.
TS
Thermo Fisher ScientificAssociate Medical Director – Principal Investigator, Clinical Research
Associate Medical Director at Thermo Fisher Scientific overseeing clinical trials and ensuring compliance with regulations. Consulting on medical protocols and fostering client relationships for successful trial conduct.
IL
Independent Living Systems, LLCMedical Director
Medical Director overseeing clinical operations for healthcare services at Independent Living Systems. Ensuring effective patient care and collaborating on clinical policies and procedures.
PH
Promises Behavioral HealthClinical Director
Clinical Director overseeing clinical operations and program development for residential treatment program. Collaborating with leadership to ensure high - quality care and staff education.
Clinical Development Medical Director leading clinical strategy and execution for drug development programs at Novartis. Ensures medical expertise is applied throughout the clinical development lifecycle.
RE
Medical Director, Field Medical Affairs for Rare Diseases at Regeneron, leading scientific discussions and evaluating health technology assessments across Europe.