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.
The Medical Director is primarily responsible for providing medical direction, management and review of clinical trials and product development with additional roles in medical affairs and drug safety. Specific tasks may include design of a clinical development program plan for new drug candidates, as well as clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents. The individual will interact with most functions to ensure the successful progress of projects and clinical trials. This individual will have industrial experience and a solid understanding of all phases of clinical drug development, translational science, and operational excellence. The individual will also oversee drug safety and medical affairs activity. Excellent written and effective verbal communication skills, ability to influence across functions and levels, and flexibility/adaptability to work in a fast-paced environment are essential.
Location: San Francisco California
Reporting Relationship: Reports to the Chief Medical Officer
• Applies disease knowledge to clinical research trial development
• Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical subteam functions.
• Drives preparation of clinical development plans in partnership with cross-functional team
• Works collaboratively with Regulatory Affairs; drafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions.
• Contributes to CSR preparation and finalization
• Contributes to development of ICFs, eCRFs and data review plans
• Monitors, and reviews safety and efficacy data in ongoing studies
• Serves as primary clinical point of contact (eligibility questions, AE management) for clinical trial sites
• Develops clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training
• Keeps abreast of rare dermatology treatments, BCC syndrome, approaches to drug development and regulatory requirements
• Develops publication plans, reviews external messaging of scientific data including journal publications, conference abstracts etc.
• Manages Investigational Brochure development and finalization
• Reviews Serious Adverse Events for causality assessment, authors or reviews key safety documents intended for regulatory submission
• A proven self-starter and team player with strong interpersonal skills who establishes & nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
• Critical thinker with a solutions-oriented mindset
• Self-motivated to work effectively in a dynamic environment
• Possess strong organizational skills and conflict resolution abilities
• Highly organized with attention to detail
• Can do attitude
• Excellent collaborative skills
• Medical degree required (candidates with a PhD and significant experience will be considered); dermatology/oncology training and/or practice highly desired
• Minimum of three years (at least Director level) of drug development experience, preferably including late-stage development
• Thorough understanding of clinical trial design
• Experience and understanding of clinical trial data monitoring and all aspects of drug development
• Knowledge of GCP and ICH guidelines is required
• Leadership and Management experiences highly desirable
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