Job Description

Looking for an experienced Program Lead for our exciting Tulisokibart asset.  This position provides oversight and leadership of clinical program execution for our Tulisokibart IBD program. In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through post-marketing approval). You will apply project management and organizational leadership expertise in our fast-paced, industry-leading, dynamic bio-pharmaceutical company. 

Core Responsibilities

• Responsible and accountable for the operational execution of a suite of clinical trials encompassing a clinical program.

• Lead and direct teams to support key program planning and execution elements (e.g., program level overviews; sr. management, and governance meetings; regulatory agency interactions; advisory meeting preparation). Serves as an escalation point for issues and promotes cross-function solutions.

• Leads efforts to maximize operational feasibility and efficiency. Ensure consistency and quality across assigned portfolio.

• Serve as the operational representative on the Product Development’s Clinical Subteam.

• Contributes to resource planning and staffing (hiring and/or project onboarding, supervision of clinical scientists and study managers).

• Collaborate and facilitate interactions with key internal and external stakeholders (e.g., KOLs, supplies) in support of clinical program objectives.

• Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations.

• May lead and/or implement process improvement and strategic initiatives.

• Management of direct reports including professional development and performance management.

Core Skills

Demonstrated ability to drive and manage clinical program(s) (e.g., strategic planning through post-approval).

This includes the ability to:

• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division

• Interact with key stakeholders across department, division, and company. Role requires proactive approach, strategic thinking, and leadership to envision, plan and execute organizational goals

• Makes decisions guided by profit plan or budget that impact support, resourcing and implementation of projects, programs and/or technologies. Demonstrated ability to effectively delegate work to meet the business needs

• Resolves complex technical, operational, and financial problems. Decisions guided by resource availability and department objectives. Ability to take a broader view of issues to maximize benefit and/or impact to the organization

• Has strong understanding of end-to-end clinical research process

• Excellent writing and communication skills

• Demonstrated leadership skills in supervising people, managing programs & processes, leading meetings and/or influencing peers and direct reports in a matrix environment

• Problem solving, conflict resolution, and critical thinking skills

• Expert knowledge of GCP and ICH regulations

• Demonstrated project management, and time management/organizational skills

• Build team capabilities through proactive coaching

• Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of Therapeutic Area or program specific requirements

• Strong communication skills with advanced oral and written English skills

• Advanced computer/database skills

Experience

• Bachelor’s degree + 12 years -OR- Master’s + 9 years -OR- PhD/PharmD + 6 years Pharmaceutical and/or clinical drug development experience. Degree in life sciences, preferred.

clinicaltrialjobs

Ideal candidate would have:

• Highly preferred: Experience in conducting global clinical trials programs, including product planning through initial filing in Gastroenterology, Dermatology, or Rheumatology, especially autoimmune or immune-mediated disorders (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, hidradenitis suppurative, atopic dermatitis, etc.)

• Managing direct reports

Candidates with the with the following experiences/expertise are highly preferred, but not required:

• Experience in conducting clinical trials in gastrointestinal, preferably autoimmune and/or immune mediated disease trials.

• Experience with selecting and utilizing programmatic vendors, including but not limited to imaging, histopathology, electronic clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.

• Experience in developing protocols and study related documents for Immunology related clinical trials

Required Skills:

Preferred Skills:

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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

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

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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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