Medical DirectorAs a clinician and scientist, you will be bridging the basic research with clinical development strategy in this scientifically rich environment. This role will provide strategic medical guidance to lead the development of new neurology therapeutics and will be accountable for the design, implementation, and conduct of clinical development program(s) to support decision milestones and regulatory requirements.
Major Activities:Clinical Development Planning
- Provide clinical leadership and strategic medical guidance for the development of new neurology therapeutics
- Responsible for creating clinical development plan(s) that foresee and support subsequent registration trials
- Maintain the highest standards of scientific and clinical knowledge.
- Stay informed and up to date of internal and external developments, trends, and other dynamics relevant to the clinical development plan, and maintain a current view of the disease area to inform strategy.
- Liaise with internal stakeholders and outside experts, advisory boards, patient advocacy groups and regulatory authorities and represent assigned programs to those groups and authorities
- May support Business Development and Licensing activities
Clinical Development Implementation
- Collaborate with clinical scientists, clinical operations, scientists and subject matter experts to develop clinical trial protocols
- Provide clinical and expert input in the development of clinical sections of Investigator Brochures, presentations, and other materials.
- Regularly engage with the relevant external investigators; participate in the identification and selection of appropriate external investigators and sites.
- Apply medical knowledge to guide the safe, ethical and efficient conduct of the trials under their responsibility
- Maintain compliance with Good Clinical Practice guidelines and Treeline Standard Operating Procedures
- Act as the medical monitor for assigned studies and conduct ongoing reviews of clinical trial data.
- Collaborate within a multidisciplinary team including biostatisticians, data managers and statistical programmers to develop study analytics and data review plans.
- Collaborate with the Translational Biomarker team to strategize, design, and implement biomarker plans.
- Review study data to ensure correct medical/scientific data interpretation for interim and final study reporting.
- Collaborate with Clinical Operations for site selection, feasibility, and query resolution etc.
- Collaborate with relevant team members to support regulatory interactions such as end of phase meetings.
Required Skills, Experience, and Education: - MD with Board-certification (or equivalent expertise) with a neurology specialty. Clinical practice experience 6gt;= 4 years.
- Additional lab-based science training is required; PhD is preferred
- Experience leading complex, global, early phase clinical programs from the pharma/biotech industry and/or credible experience from an academic medical center
- Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
- Excellent communication skills, written and oral
- Strong interpersonal skills
- Thorough knowledge of Good Clinical Practice
- Impeccable personal ethical integrity and a commitment to improving the outcomes for patients
This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $302,276 - $370,530. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.
