The Clinical Development Program Manager will be responsible for programmatic tactical execution of regulated research and clinical products, including companion diagnostic (CDx), non-CDx-IVD, Drug Development Tools (DDT) and RUO strategies. This is a highly matrixed role that requires outstanding emotional intelligence combined with detailed subject matter expertise in order to help coordinate the program across all functional areas including quality, clinical, business development, scientific programs, engineering and product teams. The Program Manager will bring together all stakeholders internally and externally to successfully design, execute on all aspects of our clinical development programs. Outstanding detailed organizational skills with a proactive mindset toward identification of all programmatic risks and mitigations is essential.
- Establish and continually communicate detailed program and project plans with critical paths and dependencies clearly identified across each area and communicate timeline progress and risks through defined operating mechanisms.
- Educate relevant leads from each functional area on the regulations impacting development programs.
- Lead the execution of research and clinical development strategies for new clinical trial, research, and medical device product development, and operationalize these strategies from development to commercialization.
- Clearly communicate strategy, progress, and risks cross functionally and proactively drive/facilitate the relationship between internal project teams and external stakeholders.
- Effectively prioritize the projects within our clinical development programs to ensure adequate resourcing and efficient delivery on priority projects for PathAI.
- Inform leadership of any identified gaps, risks, solutions to the program as a whole.
Who you are:
- Ph.D (preferred) or M.S. in a Life Science or equivalent field, plus at least 5 years of relevant industry experience
- You have a solid understanding of and experience in drug development (clinical trials, biomarker testing), assay development, and co-development for CDx programs.
- You have knowledge (training preferred) of the software development life cycle (IEC 62304), design control, and experience in leading in vitro diagnostic development teams.
- You have supported projects for FDA and other regulatory body submissions from development to validation to approval.
- You excel in leading multidisciplinary teams of scientists and engineers in highly matrixed organization is strongly preferred
- You are a strategic thinker, pro-active and agile, and you have a strong interest in bringing teams together at PathAI, as well as external partners, to bring better treatments to patients.
- Experience in histologic-based or other medical imaging in a regulated environment is strongly preferred.
For the right candidate, we'll offer a competitive salary plus equity. Your compensation is rounded out by a strong benefits package:
- Flexible work hours, with work-from-home options available
- Three weeks of paid leave per year, an additional two weeks of sick time, plus extended holidays and team-approved leave
- Ten days of 100% subsidized childcare per year
- Healthcare, vision, and dental insurance plans (HMO or PPO), with voluntary add-ons available for dependent care, life, and accident coverage
- Commuter benefit available for public transit or parking
Most importantly, you'll be doing important work with a team of people you'll genuinely enjoy spending the day with.
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.
PathAI does not accept unsolicited submissions from third-parties.
With the rise of employment phishing scams, especially during the current COVID-19 situation, we ask candidates to be extra vigilant. Be careful about providing any kind of personal information, such as location, age, or financial information to recruiters who may be impersonating PathAI employees. PathAI does not require payment for interviews or for applicants to purchase their own work supplies for reimbursement.