Opportunity
We are a clinical-stage biopharmaceutical company specializing in the development of novel long-acting therapeutics for obesity and related metabolic disorders. Our team invents, develops, and uses novel drug delivery technologies that enable controlled, predictable, and sustained release of drugs over weeks or months. Our approach has the potential to enhance pharmacokinetics, efficacy, and safety while significantly reducing dosing frequency.
Position
The Director/Senior Director, Clinical Operations will be responsible for the management, oversight, and hands-on execution of clinical studies, ensuring they are completed according to timelines, budgets, and regulatory quality standards.
Reporting to the Chief Medical Officer, the incumbent will serve as a key functional leader and subject matter expert, working cross-functionally with other functional experts to advance preclinical candidates into and through clinical development, with an initial focus on first-in-human studies.
Building on prior industry experience and solid knowledge of IND/clinical development processes, the candidate will work independently to establish and oversee all aspects of clinical operations, including CRO/vendor selection and management, establishment of study budgets and timelines, site selection and interaction with study personal, as well as development of study-related documents, to generate high quality clinical data in keeping with applicable regulatory/industry standards.
Roles and Responsibilites
- Responsible for the clinical operation function at the company and for representing clinical operations in cross-functional program teams, working closely with team leaders and other functional area subject matter experts
- Accountable for the strategic planning and operational execution of clinical trials, ensuring they are conducted within agreed upon timelines, budgets, and regulatory quality standards.
- Actively lead and/or participate in the development of clinical documents, including but not limited to protocols, ICFs, study manuals, investigator brochures, and clinical study reports.
- Responsible for maintaining constructive interactions with clinical sites to ensure that all trials and programs have clearly defined plans, strategies, and milestones.
- Actively lead the selection, management, and performance of study-related CROs, vendors, and external consultants.
- Accountable for the management of clinical budgets.
- Develop and maintain strong collaboration and communication with internal and external stakeholders, including regular communication of study-related metrics / KPIs to executive management and cross-functional study teams.
- Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices. Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), Work Instructions (WI), training, and other tools to ensure compliance with FDA Regulations
- Lead responses to any audits as required (site, internal file, process, and regulatory agencies)
- Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials, including the evaluation and implementation of clinical technologies (e.g., EDC, eTMF, CTMS) appropriate for the company’s stage of growth.
- Collaborate closely with CMC and Supply Chain teams to ensure clinical trial material (CTM) availability, stability, and proper handling/administration at clinical sites.
- Provide accurate, current updates to executive management and program teams regarding the status of clinical trials.
Qualifications
- Bachelor’s degree or higher in a relevant field, preferably related to biological or life sciences. Higher/professional degree a plus.
- 10+ years Clinical Operations experience.
- Strong experience in the set-up and management of domestic and international early and late phase clinical trials, either directly or via CRO/vendor management.
- Prior experience in metabolic, endocrine, or obesity clinical trials is highly desirable.
- Experience managing multiple projects and priorities.
- Strong working knowledge of GCP/ICH guidelines.
- Experience developing and managing departmental and study budgets and timelines.
- Strong interpersonal skills with demonstrated ability to effectively work with internal and external cross-functional groups.
- Extensive knowledge of drug development functions relevant to clinical trial conduct (e.g., data management, biostatistics, pharmacovigilance, CMC/supply chain management, etc.).
- Demonstrated ability to collaborate effectively in cross-functional teams and function effectively in a lean, fast-paced biotech environment, balancing strategic leadership with daily tactical execution.
- Excellent written, communication, and interpersonal skills, and demonstrated cultural agility.
- Ability and willingness to travel domestically and internationally as needed, such as for study site visits.
- This is a remote position. Occasional travel to the Company’s offices in Emeryville is expected/required.
We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don’t hesitate to apply!
ProLynx, Inc. is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.
Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions.
