Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma

MSD • Boston, MA

26d • $310,900 - $489,400 • Hybrid

About The Position

The Executive Director (Distinguished Scientist) and Product Development Team (PDT) lead is responsible for planning and directing clinical research involving new or marketed medicines in Oncology, Hematology. The role oversees late-stage clinical development from Phase 2 through Phase 5, including program strategy and design, protocol development, trial initiation and execution, monitoring, analysis, regulatory reporting, publication, and presentation at scientific meetings.

The Executive Director leads cross-functional product development teams responsible for program strategy and execution, provides scientific leadership to teams supporting clinical trials, and engages with external scientific leaders. The position may also involve evaluating preclinical and translational research for early development plans and IND applications; developing and executing clinical strategies; overseeing trials; integrating cross-functional perspectives; and analyzing clinical findings to inform safety, efficacy, regulatory submissions, study reports, and publications.

The role includes participation in research project teams and business development assessments, and may include management of Clinical Directors and/or Senior Clinical Directors. The Executive Director works with experts in commercialization, regulatory affairs, statistics, and manufacturing; keeps relevant corporate personnel informed about study progress and scientific developments; and leads governance presentations to senior management and committees.

The Executive Director maintains scientific expertise through awareness of new findings and methods, identifying and communicating with investigators, and attending scientific meetings. The role may include authoring or overseeing development documents, presentations, budgets, and position papers; facilitating collaborations with external researchers; and business travel. The position is based in Rahway, New Jersey, with a hybrid work arrangement and approximately 25% travel. Domestic relocation and visa sponsorship are available.

Requirements

• M.D. or M.D./Ph.D.
• At least 3 years of clinical medicine experience.
• At least 5 years of industry experience in drug development, with demonstrated success overseeing multiple studies and protocols through completion.
• Experience authoring regulatory documents and leading discussions with regulatory agencies.
• Demonstrated record of scientific scholarship and achievement.
• Proven track record in clinical medicine and background in biomedical research.
• Outstanding interpersonal and collaborative skills, with ability to function in a matrix environment.
• Excellent verbal, written, and presentation communication skills.

Nice To Haves

• Board certified or eligible in Oncology, Hematology, or a related discipline.
• Lymphoma experience.
• Prior clinical research experience and publication record.
• Product registration experience.

Responsibilities

• Plan and direct clinical research activities involving new or marketed medicines in Oncology, Hematology.
• Oversee late-stage clinical development from Phase 2 to Phase 5, including strategy, design, protocol authoring, trial initiation and execution, monitoring, analysis, regulatory reporting, publication, and presentation.
• Lead cross-functional product development teams responsible for program strategy and execution.
• Provide scientific leadership to cross-functional groups supporting clinical trials and interact with external scientific leaders.
• Evaluate preclinical and translational work to develop early clinical plans and IND applications.
• Develop clinical development strategies incorporating scientific developments, regulatory requirements, competitive factors, and commercial considerations.
• Plan clinical trials and lead the clinical subteam; monitor and manage ongoing and new trials.
• Integrate cross-functional input into strategy and plans and serve as the product development team spokesperson.
• Analyze and summarize clinical findings to support safety and efficacy decisions, regulatory applications, clinical study reports, and publications.
• Participate in internal and joint research teams concerning new compounds and further study of marketed compounds.
• Support business development assessments of external opportunities.
• Manage Clinical Directors and/or Senior Clinical Directors responsible for clinical development work, fostering a high-performance culture.
• Work with commercialization, regulatory affairs, statistics, and manufacturing experts to manage clinical development projects and keep appropriate corporate personnel informed of study progress and scientific opinion.
• Lead governance presentations to senior management and committees, communicate progress and strategy changes, align with line management, and facilitate issue escalation and cross-functional collaboration.
• Maintain scientific knowledge of new findings and research methodologies in the area of expertise.
• Identify capable investigators and establish communications with prominent clinical investigators who may assist in evaluating company medicines.
• Attend scientific meetings to maintain expertise and awareness of research activities.
• Author or oversee development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers around the world.
• Travel on company business to manage future or ongoing clinical research projects.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.
• Domestic relocation assistance.
• Visa sponsorship.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree