Pliant Therapeutics is an early stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar for progress to meet unmet medical needs for the patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company is seeking a passionate, creative, and dedicated Medical Director to join our team and contribute to our mission.
Reporting to the VP, Clinical Development, the Medical Director manages the clinical development of drug candidates, including phase I-III studies and across multiple therapeutic areas, and will assume a hands-on role in the strategic planning, implementation and oversight of clinical trials
The successful hire will have relevant experience in clinical development within pharmaceutical or biotech industry (At least 5 years). Strong background and interest in underlying science and mechanism of action of therapeutics is required. Candidate will be responsible for designing and working closely with all functions to enable clinical development goals and deliverables as well as implementation and medical monitoring of clinical trials in early and late stage development.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop protocols to execute clinical development strategies
- Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. lead study start up and database lock medical monitoring activities; address medical monitor inquiries from sites or Operations; perform data and codingreviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)
- Assure the Clinical Science department works closely with Research and Clinical Pharmacology, Regulatory, Drug Safety/Pharmacovigilance, Medical and Affairs as appropriate for effective execution of various programs
- Write/edit clinical reports, investigator brochures, conference abstractsand clinical aspects of Regulatory submissions; supports all other Regulatory activities, IND and NDA related questions
- Other duties commensurate with position as assigned
- Advanced knowledge and training in clinical research, with emphasis on the medical and regulatory requirements as related to clinical research and study design. Experience across all phases of drug development is desired, earlier phases preferred.
- Knowledge and experience in writing clinical development plans and protocols, providing medical monitoring,clinical trial budgeting and interaction with with regulatory agencies.
***Domestic and global travel may be required
KNOWLEDGE AND SKILL REQUIREMENTS:
- M.D. degree with a minimum of 5 years industry experience, in the management and execution of phase I-III trials with credible therapeutics
- Demonstrated ability to independently evaluate, interpret and present complex scientific data
- Sound understanding of statistics and demonstrated ability to critically evaluate complex drug development programs
- Demonstrated ability toteam-work within a multi-disciplinary team of peers and outside experts
- Excellent communication skills including written, oral, and presentation skills.Evidence of publication of original scientific papers in translational and/ or clinical research will be valued.
- Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet aggressive goals
- Ability to analyze complex situations and propose solutions to fundamental problems leveraging drug development knowledge
- Strongpeople management skills that focus on teamwork and building alliances; ability to resolve conflicts and to negotiate effectively.
- Strong advocate for teamwork with the initiative to develop consensus and the ability to positively manage challenge.
- Ability to effectively collaborate with affiliate and contract personnel as required
- Positive approach to work and ability to motivate team members to meet timelines and project goals is required
- Ability to develop strong relationships with major investigators and key opinion leaders within therapeutic area