- Within Clinical Development, work closely with Medical Study Lead and the Chief Medical Officer to generate protocols and amendments, make evidence-based recommendations on inclusion and exclusion criteria, outcome measures, and other aspects of overall design, procedures and conduction of clinical studies.
- Review data from clinical trials, including ongoing review of clinical trial safety data, laboratory data, ECGs, as required in collaboration with PSPV colleagues; liaise with the clinical development team and if requested with the ACELYRIN Safety Committees.
- Provide support on data analysis with key input on data interpretation and presentation, in partnership with cross-functional colleagues.
- Experience in collaboration with statistics, safety, and clinical operations functions is required.
- Support/provide content generation and review key internal and external documents such as Investigator Brochures, Risk Language, Informed Consent forms, study protocols, study operations manuals, safety documents, etc, working closely with cross-functional team members.
- Support Medical Lead in preparation and presentation of safety data to DMC/DSMB according to charter.
- Contribute to writing of regulatory documents and responding to regulatory inquires in collaboration with regulatory leads and others, as required.
- Interact with study investigators and site staff regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed.
- Work closely with and manage vendors as needed.
- Provide guidance to managers before, throughout, and following clinical trials to ensure compliance for proper study conduct throughout the clinical trial development through execution.
- Act as a clinical interface and support site engagement activities and presentations, interactions with key opinion leaders,
- Review of non-clinical data as required.
- Review of clinical pharmacology data as required.
- Participate in evaluation of life cycle management opportunities including assessment of adjacent indications, assessment of investigator-initiated trial proposals, etc. as requested.
- Support development of medical affairs materials, based on clinical trial datasets. Review content of scientific abstracts to support presentation to scientific conferences tailored to the respective therapeutic area.
- Participate in due diligence activities as requested.
- MD, ideally with specialization in a relevant discipline, with at least 3 years of biotech/pharmaceutical experience in clinical development related activities.
- Demonstrated ability to work cross functionally in a matrixed environment.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols
- Excellent written and oral English communication skills
- Ability to work independently as well as cross-functionally
- Ability to adapt to a fast paced work environment
- Results and Action Oriented
- Ability to Deal with Ambiguity
- Ability to organize teams around focused task resolution
- Demonstrated Strategic and Problem Solving in matrixed environment
- Demonstrated Functional and Technical Skills for Clinical Development
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Medical Director, Clinical Development - Agoura Hills, United States - ACELYRIN, INC.
3 weeks ago
Description
Job Description
Job DescriptionSalary: $225,000 - $240,000ACELYRIN INC, CA, USA
ACELYRIN INC
Medical Director, Clinical Development
At ACELYRIN, INC the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency. Our key value of courageous caring means putting patients first and having the courage needed to quickly solve challenging issues. We strive to redefine what is possible and quickly bring innovative therapies to bear against serious diseases.
Location: Agoura Hills, CA / South San Francisco, CA / Hybrid /Remote
Job Title: Medical Director, Clinical Development
Reports To: Sr Medical Director, Clinical Development
Function: Clinical Development
Job Type: Full Time
Position Summary:
A member of ACELYRIN ́s clinical study team, the Medical Director will be a key contributor to the design, operation, analysis and reporting of clinical studies. Activities include critical scientific input into protocols, supporting study conduct oversight according to best practice and national and international guidelines and regulations, as well as ACELYRIN's objectives and standard operating procedures (SOPs).
Responsibilities:
Qualifications and Skills Required:
Essential behaviors and ways of working:
ACELYRIN, INC, does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.
Candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.
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