- Responsible for large study and/or multiple study management, including the overall clinical project plan, study timelines and deliverables, as well as risks and contingencies
- Responsible for leading clinical study team to ensure alignment to timelines, risk management and data quality.
- Oversee clinical operations budget and financial reporting, including CRO and site contractual agreements.
- Lead the selection of vendors (CRO, IRB, Central Lab, etc.) and study sites.
- Develop and oversee patient recruitment strategies, project metrics tracking, and Trial Master File (TMF) design and set up.
- Author and review study documents (Protocol, IC, monitoring plans, pharmacy manual, Informed Consent Form, DSMB/Steering Committee/Charters, CSR).
- Responsible for vendor, PI and committee management and communication.
- Ensure all aspects of GCP are complied with at all times
- Coach CRAs in various aspects of the trial that are relevant to particular project issues. Implement training programs for CRAs and clinical site staff.
- Establish and maintain effective communication and collaboration with functional area peers, as well as leaders in order to meet program objectives and support achievement of goals. Serve as liaison between clinical, pre-clinical, manufacturing, regulatory, and legal departments.
- Drive functional excellence by implementation of innovative and best-in-class procedures related to clinical trial execution, establishing global standards in SOPs/WI.
- Lead overall strategy and support inspection readiness activities and responses to audit findings.
- Work closely with all members of the executive leadership team to facilitate driving new product development, global product registration and commercial release of the new products.
- Bachelor's degree in Life Sciences, Nursing or Pharmacy is required. Medical background and advanced degree preferred.
- Minimum of 12-15 years' experience in the pharmaceutical industry or clinical research organization.
- Extensive experience developing project and budget plans as well as global clinical management and budget oversight experience.
- Experience running clinical studies in both the US and international and experience with regulatory filings from IND to NDA in US and abroad.
- Strong project management skills, including budget analysis.
- Knowledge of statistics and clinical study design.
- Strong leadership skills and experience leading teams.
- Advanced knowledge of pharmaceutical business, drug development, regulatory and compliance requirements with extensive knowledge of clinical operations, project management principles and tools.
- Detailed knowledge of Good Clinical Practices (GCP).
- Demonstrated expertise in oversight of CRO relationships and performance as well as risk management and implementing mitigation plans at study and program level.
- Strong interpersonal and communication, problem solving and organizational skills and ability to manage multiple projects.
- Budget and contract negotiations essential
- Proficient MS Office skills including Microsoft Project
- Therapeutic experience in design and conduct of Phase I (pharmacology studies, bioequivalence, pharmacokinetic and pharmacodynamics), and phase II/III trials in endocrinology/metabolic preferred
- Ability to travel (approximately 15%).
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Director/Senior Director, Clinical Operations - South San Francisco, United States - Septerna
Description
The Company
Septerna is a biotechnology company with a vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company, and a mission to develop life-changing medicines for patients.
This approach enables access for the first time to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs.
Septerna has an emerging pipeline of GPCR-targeted small molecule programs with growth potential to reach many GPCRs that have been undruggable and unexploited to date.
Septerna was launched by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures.For more information see:
Join a multidisciplinary team of colleagues focused on creating revolutionary medicines to address significant needs of patients.
Bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals, and contribute your passion, creativity, and energy to our mission.
At Septerna we embrace diversity of thought, expertise, and background.We share a fearless pursuit of ground-breaking innovations, and our employees learn from each other and succeed as a team.
THE ROLE
The Director/Senior Director of Clinical Operations is a critical leadership position and is responsible for leading all clinical operations activities within the organization.
This individual will be primarily focused on managing and executing domestic and international clinical studies, ensuring rapid enrollment, overseeing exceptional site management, and selecting and managing CRO's with strong skills in the high-quality data collection.
This position is responsible for multi-national therapeutic clinical operational programs in Phase 1 to 3 drug development programs.Key Responsibilities:
Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training.
Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Note to Employment Agencies:
Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
Director/Senior Director, Clinical Operations professionals in South San Francisco
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