Role: Clinical Trial Manager
Reporting to: Vice-President Clinical Operations
Location: San Francisco, SOMA
PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm, a BridgeBio company, is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. Topical patidegib gel has shown early promise in a Phase 2 clinical study in Gorlin Syndrome by blocking the disease at its source within the hedgehog signaling pathway. Topical patidegib was developed to provide the efficacy previously demonstrated by oral patidegib in Phase 1 trials, but without the adverse systemic side effects of oral hedgehog inhibitors. Patidegib’s gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for ongoing, at-home management of Gorlin Syndrome.
This is an exciting opportunity to work within a fast paced, busy environment with a dedicated passionate intelligent team. As a Clinical Trial Manager (“CTM”) you will be responsible for managing operational activities of assigned clinical programs. You will partner with key stakeholders – internal and external – to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for performing in a cross-functional environment.
Specific responsibilities of the incoming Clinical Trial Manager:
• Responsible for representing Clinical Operations (“ClinOps”) on cross-functional study teams and Vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
• Manage cross-functional study teams and vendor operational meetings to ensure project goals and timelines are met
• Responsible for the review and oversight of tasks in study data management plans for operations and all operational activities associated with clinical trials
• Responsible for ensuring that all components of the trial master file (TMF/eTMF) are up to date and accurate for Pellepharm assigned investigational trials
• Responsible for operational guidance for investigators and provide CRO training related to the study conduct
• Responsible for managing queries for clinical studies from CROs and address issues raised by CROs or other service providers
• Participate in the conduct of audits and support regulatory inspections related to GCP
• Address consistency in collection, processing and evaluation of clinical data
• Contributes to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
• Represent Clinical Operations on cross-functional teams
• Support Pellepharm sponsored clinical trials and development programs
Given the “small biotech” nature of the Company, cultural fit of the successful candidate is an important criterion for his/her success at PellePharm. Desired characteristics include a high level of curiosity, intelligence, ability to work independently, “can do” attitude and an entrepreneurial spirit.
Specific Qualifications Include:
• BA required in a scientific/medical field. Advanced degree preferred.
• 3+ years of experience in Clinical Operations, working with CROs and other vendors
• Previous experience working in cross-functional environment
• History of successfully developing effective relationships with outside vendors and CROs
• Demonstrated skills in negotiation, multi-tasking, organization and decision making
• Proficiency with Microsoft applications
• Ability to travel to regional and global sites, approximately 25% of the time
• Prior experience working in a start-up environment is a highly desired
• Highly organized with attention to detail
• Self – starter, able to work independently
• Strong problem solving and organizational skills
• Excellent collaborative skills
• Can do attitude
Other than working with a great team of smart, passionate and energetic people, Pellepharm also offers a competitive salary and benefits package that includes 100% coverage of health care premiums, life insurance, 401k and perks.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.
Pellepharm is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.
IF YOU ARE INTERESTED IN THIS ROLE, PLEASE SEND YOUR CV TO CAREERS@PELLEPHARM.COM