Distinguished Scientist (Executive Director), Asset Development Team Leader Full-time NEW

Executive Director, Clinical Research

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 meetings. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.

Specifically, the Executive Director may be responsible for:

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
• Developing clinical development strategies for investigational or marketed vaccines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations
• Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed vaccines
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
• Participation 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.
• 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
• 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
• Facilitating 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.

Education:

• Pharm.D.
• Clinical research training and experience required.

Required Experience and Skills:

• 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

Required Skills:

Clinical Development, Clinical Research Methods, Detail-Oriented, Drug Safety Surveillance, Ethical Standards, Exercises Judgment, Innovation, Leadership, Professional Integrity, Protocol Development, Scientific Leadership, Scientific Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The salary range for this role is

$255,800.00 – $402,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated