Medical Director

Treeline Biosciences•Watertown, MA

1d•$302,276 - $370,530

About The Position

Medical Director About the Position: The Medical Director will provide strategic medical guidance to lead the development of new hematology / oncology agents. Responsible for one or more clinical programs across indications, multiple assets, or a large complex program. Accountable for the design, implementation, and conduct of clinical development program(s) to support decision milestones and regulatory requirements.Treeline has a robust research pipeline from discovery to clinic, and we are working rigorously to leverage 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. Responsibilities: Clinical Development Planning Provides clinical leadership and strategic medical guidance for the development of new agents across the company’s early pipeline Responsible for creating clinical development plan(s) that foresee and support subsequent registration trials Maintains the highest standards of scientific and clinical knowledge in the specific therapeutic area(s) of assignment. Stays informed and up to date of internal and external developments, trends, and other dynamics relevant to the clinical development plan, and maintains a current view of the relevant disease area(s) to inform strategy. Liaises 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 Collaborates with clinical scientists, clinical operations, scientists and subject matter experts to develop clinical trial protocols Provides the clinical and expert input in the development of clinical sections of Investigator Brochures, presentations, and other materials. Regularly engages with the relevant external investigators; participate in the identification and selection of appropriate external investigators and sites. Applies their medical knowledge to guide the safe, ethical and efficient conduct of the trials under their responsibility Maintains compliance with Good Clinical Practice guidelines and Treeline Standard Operating Procedures Acts as the medical monitor for assigned studies and conduct ongoing reviews of clinical trial data. Collaborates within a multidisciplinary team including biostatisticians, data managers and statistical programmers to develop study analytics and data review plans. Collaborates with the Translational Biomarker team to strategize, design, and implement biomarker plans. Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting. Collaborates with Clinical Operations for site selection, feasibility, and query resolution etc. Collaborates with relevant team members to support regulatory interactions such as end of phase meetings.

Requirements

MD with Board-certification (or equivalent expertise) in a Heme/Onc sub-specialty.
Clinical practice experience ≥ 4 years.
Additional lab-based science training is required; PhD is preferred
Experience leading complex, global, early phase, oncology 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

Responsibilities

Clinical Development Planning Provides clinical leadership and strategic medical guidance for the development of new agents across the company’s early pipeline
Responsible for creating clinical development plan(s) that foresee and support subsequent registration trials
Maintains the highest standards of scientific and clinical knowledge in the specific therapeutic area(s) of assignment.
Stays informed and up to date of internal and external developments, trends, and other dynamics relevant to the clinical development plan, and maintains a current view of the relevant disease area(s) to inform strategy.
Liaises 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
Collaborates with clinical scientists, clinical operations, scientists and subject matter experts to develop clinical trial protocols
Provides the clinical and expert input in the development of clinical sections of Investigator Brochures, presentations, and other materials.
Regularly engages with the relevant external investigators; participate in the identification and selection of appropriate external investigators and sites.
Applies their medical knowledge to guide the safe, ethical and efficient conduct of the trials under their responsibility
Maintains compliance with Good Clinical Practice guidelines and Treeline Standard Operating Procedures
Acts as the medical monitor for assigned studies and conduct ongoing reviews of clinical trial data.
Collaborates within a multidisciplinary team including biostatisticians, data managers and statistical programmers to develop study analytics and data review plans.
Collaborates with the Translational Biomarker team to strategize, design, and implement biomarker plans.
Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting.
Collaborates with Clinical Operations for site selection, feasibility, and query resolution etc.
Collaborates with relevant team members to support regulatory interactions such as end of phase meetings.