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Senior Medical Director, Oncology Asset Development Team

3 months ago

Lake Wales, Florida, United States Merck Full time

Job Description

Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new Oncology medicines within an Asset team. Our Company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.

Specifically, the Senior Director may be responsible for:

  • Providing scientific and medical leadership for strategic alliances and Co-partnership opportunities.
  • Supporting the team in prioritizing external collaborations. Recognize and capitalize on opportunities to adapt direction in light of project successes and failures and market changes.
  • Managing selected opportunities, developing strategy and detailed milestones, measures, timelines and budgets to achieve designated value inflection points.
  • Identifying, negotiating and maintaining critical external partnerships.
  • 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 Oncology 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 Oncology 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; and
  • Participating in internal and joint internal/external research project teams relevant to the development of new compounds and combinations of these with marketed compounds.

In executing these duties, the Senior Director may:

  • 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; and
  • Assist the Executive Director/Associate Vice President in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of 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
  • 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 his/her 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 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
  • 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
  • Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Education:

  • Required: M.D or M.D./PhD combination
  • Board Certified or Eligible in Medical Oncology (and/or Hematology), Radiation Oncology, Surgical Oncology or a related discipline is preferred. An equivalent combination of training and experience will be considered.

Required:

  • Must have experience in industry or senior faculty in academia
  • Minimum of 3 years of clinical medicine experience
  • Minimum of 1 year of industry experience in drug development or biomedical research experience in academia
  • Demonstrated record of scientific scholarship and achievement
  • A 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 are essential.
  • High level of verbal and written communication, including presentation skills.
  • Strong learning agility and growth mindset

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

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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, generally Tuesday, Wednesday and either Monday or 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".

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/26/2024

*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.

Job Posting End Date:06/26/2024

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.

Requisition ID:R297087