Clinical Trial Manager
PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm 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. The U.S. Food and Drug Administration awarded a Breakthrough Therapy Designation and Orphan Drug Designation to Patidegib after presenting positive Phase II data evaluating the safety and efficacy of the therapy in patients with Gorlin Syndrome. PellePharm is aiming to initiate the Phase III trials of the topical hedgehog inhibitor in 2019. PellePharm recently announced a partnership with Leo Pharma, a Dutch pharmaceutical company, which enables the company to execute the Phase III studies and marks Leo Pharma’s entrance in rare skin disease.
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 the initiation and execution of the company’s 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:
- The initiation and efficient day-to-day management of the clinical trial(s).
- Responsibility for selection and oversight of CRO and other vendors.
- Responsibility for site selection and management.
- Establishment of procedures to ensure adherence to trial protocols and administrative requirements.
- Management of cross-functional study teams and vendor operational meetings to ensure project goals and timelines are met.
- Timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective data management. Address consistency in the collection, processing, and evaluation of clinical data.
- Monitor trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
- Management of the trial budget(s) and maintenance of the accounts.
- Act as the point of contact for all external and internal agencies.
- Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes. Participate in the conduct of audits and support regulatory inspections related to GCP.
- Provision of regular and ad hoc information, both written and verbal, to the internal and external teams, to include reports, updates, guidance, and possibly a newsletter.
- Ensure 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.
- Manage queries for clinical studies from CROs and address issues raised by CROs or other service providers.
- Contribute to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements.
- Support PellePharm sponsored clinical trials and development programs.
Given the “small biotech” nature of the Company, the cultural fit of the successful candidate is an important criterion for his/her success at PellePharm. Must have characteristics include a high level of self – motivation, ability to work independently, “can do” attitude, resilience and a sense of urgency. The ideal candidate will have strong clinical operations background and excellent communication and collaboration skills.
Specific Qualifications Include:
- BA required in a scientific/medical field.
- 10+ years of experience in Clinical Operations, working with CROs and other vendors.
- Previous experience working in a 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 Suite applications.
- Ability to travel to regional sites, approximately 25% of the time.
- Prior experience working in a start-up environment is highly desired.
- Highly organized with attention to detail
- Self – starter, able to work independently
- Strong problem solving and organizational skills
- Excellent collaborative skills
- Passion for meeting patient needs
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, flexible, 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.