M

Merck

Makes medicines, vaccines and animal treatments

Executive Director - Multiple Teams

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A Doctor of Medicine (M.D.) or M.D./Ph.D. is required.
  • At least 3 years of clinical medicine experience is required.
  • At least 5 years of industry experience in drug development, with demonstrated success overseeing multiple studies and protocols through completion, is required.
  • Experience authoring regulatory documents and leading discussions with regulatory agencies is required.
  • A demonstrated record of scientific scholarship and achievement is required.
  • A proven track record in clinical medicine and a background in biomedical research are required.
  • Outstanding interpersonal and collaborative skills, and the ability to function in a matrix environment, are required.
  • Clear, impactful verbal and written communication and presentation skills are required.
  • The required skills include clinical development, clinical judgment, clinical medicine, clinical trial development, ethical standards, hematology, intellectual curiosity, interdisciplinary problem solving, lymphoma, mentorship, program strategy, regulatory compliance, scientific leadership, senior program management, and strategic planning.

Responsibilities

  • Plan and direct clinical research activities involving new or marketed medicines in the Oncology therapeutic area, Hematology section.
  • Manage and oversee the entire late-stage clinical development cycle from Phase 2 to Phase 5, including program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.
  • Lead cross-functional product development teams overseeing program strategy and execution, provide internal scientific leadership for cross-functional areas supporting clinical trials, and interact externally with key scientific leaders.
  • Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
  • Develop clinical development strategies for investigational or marketed medicines that incorporate scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.
  • Execute the clinical strategy, plan clinical trials including design, operational plans, and settings, and lead the clinical subteam.
  • Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed medicines.
  • Lead cross-functional product development teams overseeing overall strategy and execution for investigational or marketed medicines.
  • Integrate cross-functional input and expertise, ensure perspectives are incorporated into the strategy or plan, and serve as the product development team spokesperson.
  • Analyze and summarize clinical findings from studies to support safety and efficacy decisions, new drug applications, clinical study reports, and publications.
  • Participate in internal and joint internal/external research project teams relevant to developing new compounds and further studying marketed compounds.
  • Support business development assessments of external opportunities.
  • Manage Clinical Directors and/or Senior Clinical Directors responsible for clinical development work, demonstrating effective leadership and fostering a high-performance culture.
  • Work with experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assist the Associate Vice President and/or Vice President in keeping appropriate corporate personnel informed about study progress, competitor drugs, and relevant internal and external scientific opinions.
  • Lead internal governance presentations to senior management and committees, communicate product-development progress and key strategy changes between stage gates, ensure early alignment with line management, and facilitate issue escalation and cross-functional collaboration for governance approval.
  • Maintain awareness of scientific developments, research methodologies, and new findings within the area of expertise.
  • Identify scientifically and operationally strong investigators who can assist in developing investigational and marketed drugs.
  • Establish communications with prominent clinical investigators in the relevant field, particularly those willing and able to assist in evaluating the company’s drugs.
  • Attend appropriate scientific meetings to maintain competency and awareness of research activities in the area of responsibility.
  • Author and/or oversee detailed 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.

Desired Qualifications

  • Board certification or eligibility in Oncology, Hematology, or a related discipline is preferred.
  • Lymphoma experience is preferred.
  • Prior specific experience in clinical research and a prior publication record are preferred.
  • Product registration experience is desirable.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

Recently Posted Jobs

Explore more opportunities at Merck

See more jobs