FreshRemote.Work

Director, Clinical Research, Cardiovascular and Respiratory

USA - New Jersey - Rahway

Job Description

Our Clinical Research team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

JOB DESCRIPTION:

Summary, Focus and Purpose  

The Cardiovascular and Respiratory Clinical Research Director has primary responsibility for planning and directing clinical research activities involving new or marketed cardiovascular and respiratory medicines. Our Company's cardiovascular and respiratory medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.

Key Functions: Specific Responsibilities

  • Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and investigational new drug applications

  • Creating clinical development strategies for investigational or marketed cardiovascular and respiratory drugs

  • 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 cardiovascular and respiratory drugs

  • Analyzing and summarizing 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

Specific Responsibilities Implementation

  • Supervise the activities of Clinical Scientists in the execution of clinical studies

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

  • Assist the leadership team in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs

  • Obtain internal and external expert opinion on scientific questions relevant to areas of responsibility

Maintain Strong Scientific Knowledge

  • Maintaining awareness of scientific developments within one’s area of expertise, in terms of new scientific findings and research methodologies

  • Identifying 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 fields of interest, particularly those who would be willing and able to assist in the evaluation of our Company drugs; and

  • Attending appropriate scientific meetings to maintain one’s competency and awareness of research activities in areas of responsibility

Goal Accomplishment

  • 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 20% of the time to manage future or ongoing clinical research projects

Education

  • M.D or M.D./Ph.D.

Required Experience and Skills

  • Work independently and as a team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

  • Three years clinical medicine experience

  • One year industry experience in drug development or biomedical research experience in academia

  • 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

Preferred Experience and Skills

  • Board Certified or Eligible Cardiologist or Pulmonologist

  • Prior specific experience in clinical research and prior publication.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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

Learn more about your rights, including under California, Colorado and other US State Acts

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 presence.This 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$243,500.00 - $383,300.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/20/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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Job Profile

Regions

North America

Countries

United States

Restrictions

Hybrid Hybrid work Hybrid work model On-site Puerto Rico residents only US and Puerto Rico residents only

Benefits/Perks

Bonus eligibility Diverse workplace Equal opportunity employer Flexible work Flexible work arrangements Healthcare Health Care Hybrid work Hybrid work model Inclusion Inclusive environment Insurance Meetings Paid holidays Retirement benefits Sick Days Team environment Vacation

Tasks
  • Analyze clinical findings
  • Collaborate with cross functional teams
  • Communications
  • Compliance
  • Directing clinical research activities
  • Execution
  • Innovation
  • Leadership
  • Manage clinical development
  • Manage clinical development cycle
  • Monitor clinical trials
  • Plan and direct clinical research
  • Planning
  • Planning and directing clinical research activities
  • Planning clinical trials
  • Reporting
  • Supervise Clinical Scientists
Skills

Analysis Biomedical Research Clinical Clinical Development Clinical Development Strategies Clinical Medicine Clinical Research Clinical Studies Clinical trials Clinical Trials Design Commercialization Communications Compliance Cross-functional Collaboration Data analysis Design Development Drug Development Early clinical development Education Evaluation Execution Healthcare Inclusion Innovation Interpersonal Investigational new drug applications Leadership Manufacturing Medicine Methodologies Monitoring Operational Organization Planning Project Management Regulatory Regulatory Affairs Regulatory reporting Reporting Research Research Experience Research Methodologies Safety Scientific communication Scientific Knowledge Statistics Study Design Teams

Experience

4 years

Education

AS Business Communications Health Care M.D. M.D./Ph.D. Regulatory affairs Statistics

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9