Medical Director

Treeline Biosciences•Watertown, MA

25d•Onsite

About The Position

Medical Director Treeline has a robust research pipeline from discovery to clinic, and we are leveraging this for the greatest possible impact for patients. As 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.

Requirements

MD with Board-certification (or equivalent expertise) with a neurology specialty.
Clinical practice experience ≥ 4 years.
Additional lab-based science training is required
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

Nice To Haves

PhD is preferred

Responsibilities

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
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.