Senior Director, Clinical Research, Cardiovascular and Respiratory

Job Description

The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the insert name of TA therapeutic area. Our companys insert name of TA medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design initiation execution monitoring analysis regulatory reporting and publication.

Role Responsibilities:

Specifically the Senior Clinical Director may be responsible for:

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications

• Developing clinical development strategies for investigational or marketed insert indication drugs

• Planning clinical trials (designing collaborating on operational plans etc.) based on the clinical development strategy

• Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs

• 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

• Participating in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds

• Supporting business development assessments of external opportunities

The Senior Director May:

• Actively engage with other functional areas in support of study execution

• Work closely with a cross-functional group of experts in commercialization regulatory affairs statistics and manufacturing to manage clinical development projects

• Assist the Executive Director and/or Associate Vice President in ensuring that appropriate personnel are informed of the progress of studies of our company and competitors drugs

• Provide expert opinion internally and externally on relevant scientific questions within their responsibility.

The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:

• Maintaining awareness of scientific developments within his/her area of expertise in terms of new scientific findings research methodologies

• Identifying scientifically and operationally strong investigators who can assist in the development of our companys investigational and marketed drugs

• Establishing communications with prominent clinical investigators in his/her particular field of interest particularly those who will be willing and able to assist in the evaluation of our companys drugs

• Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.

To accomplish these goals the Senior Director may:

• Author 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 about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Education:

• M.D or M.D./Ph.D.

Required Experience and Skills:

• Must have experience in industry or as senior faculty in academia

• Minimum of 3 years clinical medicine experience

• Minimum of 3 years of industry experience in drug development or biomedical research experience in academia

• Demonstrated success in overseeing clinical studies and protocols

• Demonstrated record of scientific scholarship and achievement

• Proven track record in clinical medicine and background in biomedical research

• Strong interpersonal skills as well as the ability to function in a team environment

• Outstanding verbal and written communication and presentation skills

Preferred Experience and Skills:

• Board Certified or Eligible in insert specialty or related discipline

• Prior specific experience in clinical research and prior publication

Required Skills:

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

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 employees 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 can apply for this role through (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

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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.

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