Avp/Section Head, Global Clinical Development - Hiv

Job Description

The Associate Vice President (AVP)/Section Head, Global Clinical Development, HIV will focus on driving strategy, development, and life-cycle management activities in the HIV Therapeutic Area. The incumbent will be expected to lead multiple programs in various stages of development, therefore requiring someone who has built and lead Clinical Development plans from the ground up through registration. They will also be responsible for guiding Product Development Team (PDT) Leaders and Clinical Directors within their group to ensure that these programs are being executed effectively according to approved strategies and plans. They will require a solid understanding of the disease area, the functions and processes relevant to drug development, and project management principles as applicable to the pharmaceutical industry.

Primary Responsibilities:

• Leads development for multiple HIV projects, including pipeline candidates and licensed products. The Section Head manages PDT Leaders and Clinical Directors responsible for the design and medical monitoring of clinical studies.

• Supervises development of clinical documents including protocols, clinical study reports and background documents.

• Interfaces with functional experts across the enterprise to ensure operational excellence in the late development of assets within the HIV Section.

• May serve as a senior therapeutic area content expert within the company, providing input into research and business development priorities and prioritization of clinical assets.

• May serves as the senior liaison for relevant stakeholders in the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies, Policymakers)

• Responsible for managing, coaching, and mentoring Clinical Directors and developing the next-level talent pool within the HIV Section.

Education:

• Advanced degree (MD, MD/PhD) with at least 8+ years' experience in antiviral clinical research and drug development. Prior industry experience is required; HIV experience is strongly preferred.

Required Experience and Skills:

• Experience bringing drugs through various stages of Clinical Development, with an emphasis on late-stage development.

• Experience with planning and execution of strategies for product registration and commercialization / life-cycle management.

• Strong leadership skills with a proven track record of hiring, mentoring, and retaining top talent.

• Demonstrated ability to collaborate and network well within the organization; widely recognized within the organization as an expert in drug development.

• Demonstrated ability to understand and manage, with appropriate support, the resources, time, and budgets for assigned projects; is business-savvy and results-oriented.

• Proven ability to analyze, recommend, and communicate scientific information and influence team initiatives cross-functionally.

• Excellent written and oral communication skills.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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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”.

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Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R240251