Distinguished Scientist (Executive Director), Asset Development Team Leader

Merck•Rahway, NJ

3d•Hybrid

About The Position

The Executive Director has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs for oncology indications. The Executive Director will manage and oversee the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. The Executive Director may manage other Directors and/or Senior Directors responsible for oncology clinical development programs or projects. Mentoring and career development for direct reports (when applicable) will be a key function of the role. Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Vice President in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Executive Director is responsible for maintaining a strong scientific fund of knowledge by maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies, identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs, establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs, and attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility. To accomplish these goals, the Executive Director may oversee authoring of detailed development documents, presentations, budgets, and position papers for internal and external audiences, manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions, and facilitate collaborations with external researchers around the world. Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Requirements

Pharm.D.
Clinical research training and experience required
Minimum of 5 years of industry experience in drug development or biomedical research experience in academia or an equivalent combination of academic and industry experience
Minimum of 3 years of clinical and/or safety medicine experience
Demonstrated record of scientific scholarship and achievement
Understanding of full E2E drug development process and ideally candidate would have in-depth experience in early and/or late development
Has demonstrated success in being a critical team member for multiple studies and protocols
Knowledge and ability to originate new program ideas and recommends expansion or curtailment of clinical trials on the basis of results and/or scientific information, including business development and in-licensing opportunities
Good evidence of an ability to devise and implement strategic initiatives across functional groups and global pharma teams
Demonstrated experience in the design, implementation, and analysis of clinical trials, including safety
Strong interpersonal skills, as well as the ability to function in a team environment are essential
High level of verbal and written communication, including presentation skills
Strong learning agility and growth mindset
Clinical Development
Clinical Research Methods
Detail-Oriented
Drug Safety Surveillance
Ethical Standards
Exercises Judgment
Innovation
Leadership
Professional Integrity
Protocol Development
Scientific Leadership
Scientific Writing

Nice To Haves

Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: No
Valid Driving License: No
Hazardous Material(s): n/a

Responsibilities

Evaluate pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
Develop clinical development strategies for investigational or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
Plan clinical trials (design, operational plans, settings) based on these clinical development strategies
Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed vaccines
Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
Participate in internal and joint internal/ external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities
Mentor and provide career development for direct reports (when applicable)
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
Assist the Vice President in ensuring that appropriate corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility
Maintain awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies
Identify scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
Establish communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs
Attend appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility
Oversee authoring of detailed development documents, presentations, budgets, and position papers for internal and external audiences
Manage a complex matrix of internal stakeholders within clinical development (i.e. across existing PDTs and TAs) and across functions
Facilitate collaborations with external researchers around the world