Senior Clinical Director, Clinical Research, Hematology

MSD•Boston, MA

7d•$282,200 - $444,200•Hybrid

About The Position

The Senior Clinical Director (Senior Principal Scientist) plans and directs clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically within Hematology. The company’s Oncology medicines span all phases of clinical development, from preclinical research through post-licensure. For assigned studies, the Senior Clinical Director may oversee the full clinical development cycle, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The role develops clinical strategies and trials, provides medical oversight of study conduct, and analyzes clinical findings to inform safety and efficacy decisions and support regulatory submissions, clinical study reports, and publications. It also involves collaboration with internal and external research teams, support for business development assessments, engagement with cross-functional experts, and communication of study progress and scientific opinions. The Senior Clinical Director maintains expertise in the field by tracking scientific developments and research methods, identifying and building relationships with investigators, and attending scientific meetings. The role may also involve authoring development documents, presentations, budgets, and position papers; facilitating worldwide collaborations with external researchers; and traveling on company business approximately 20% of the time.

Requirements

M.D. or M.D./Ph.D.
Experience in industry or as senior faculty in academia.
At least 3 years of clinical medicine experience.
At least 3 years of industry experience in drug development or biomedical research experience in academia.
Demonstrated success overseeing clinical studies and protocols.
Demonstrated record of scientific scholarship and achievement.
Proven track record in clinical medicine and a background in biomedical research.
Strong interpersonal skills and ability to function in a team environment.
Outstanding verbal and written communication and presentation skills.
Skills listed include clinical development, clinical documentation, clinical judgment, clinical medicine, clinical reporting, clinical research management, clinical trial development and management, data analysis, decision-making, drug development, early clinical development, ethical standards, Hematology, Hemodialysis, Hemodynamic, intellectual curiosity, interdisciplinary problem solving, mentorship, Nephrology, regulatory affairs and compliance, scientific consulting, and scientific publications.

Nice To Haves

Board certified or board eligible in Oncology, Hematology, or a related discipline.
Prior specific experience in clinical research and prior publication.

Responsibilities

Evaluate preclinical and translational work to develop early clinical development plans and Investigational New Drug applications.
Develop clinical development strategies for investigational or marketed Hematology drugs.
Plan clinical trials, including study design and collaboration on operational plans.
Provide medical oversight and oversee the conduct of ongoing or new clinical trials for investigational or marketed drugs.
Analyze and summarize clinical study findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications.
Participate in internal and joint internal/external research teams involved in developing new compounds and further studying marketed compounds.
Support business development assessments of external opportunities.
Engage with other functional areas to support study execution and work with experts in commercialization, regulatory affairs, statistics, and manufacturing on clinical development projects.
Help ensure appropriate personnel are informed about the progress of company and competitor drug studies.
Provide expert opinions internally and externally on relevant scientific questions.
Maintain awareness of scientific developments and research methodologies in the area of expertise.
Identify strong clinical investigators and establish communications with prominent investigators who may assist in evaluating company drugs.
Attend scientific meetings to maintain competency and awareness of research activities.
Author development documents, presentations, budgets, and position papers for internal and external audiences.
Facilitate collaborations with external researchers around the world.
Travel on company business approximately 20% of the time to manage future or ongoing clinical research projects.