Director, Clinical Operations and Program Management; U.S. Scientific Affairs – milvexian

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

Scientific Affairs, a division of Johnson & Johnson's Family of Companies, is recruiting for a Director, Clinical Operations and Program Management, milvexian, within the Scientific Affairs US Team located in Titusville, NJ.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Job Description

The Director, Clinical Operations and Program Management is primarily responsible for leading the program management, project management, and alliance management activities for the Medical Affairs team. This individual will manage the overall strategy, clinical and medical operations, and execution for the field and home office milvexian medical team. This individual will also develop & maintain critical internal & external alliances for the overall department. This role will be accountable and responsible for planning and execution of medical affairs data generation efforts including clinical and operational implementation of company sponsored studies (CSS), investigator-initiated studies (IIS), collaborative studies, and post marketing commitments.  This person will manage the departmental budgets and will be a primary contributor to annual budget planning. Working with the cross functional team, they will take lead in the development of therapeutic area strategic plans, including the Business Plan (BP). Key partnerships include Therapeutic Area Lead, home office and field Medical team members, Medical and Scientific Communications Teams, US commercial partners, Cross US Medical Affairs Therapeutic Areas, Global Clinical Development Organization, Finance and Procurement, Global Commercial Strategic Organization, Global Medical Affairs, Regulatory Affairs, Research & Development, Global Safety, HR, HCC, Legal and counterparts working as part of the BMS alliance.

This role will report to the Chief Scientific Officer, Scientific Affairs VP and is a member of the milvexian Medical Affairs Leadership Team.

Key Responsibilities

• Provide leadership in establishing core competencies of program and project management that aligns with the key operational priorities within the enterprise;
• Actively participate in milvexian cross functional leadership teams, contributing to the overall strategic direction of the franchise.
• Collaborate with other leaders within Medical Affairs to develop and implement departmental strategic imperatives and strategic plans.
• Lead integration of essential business functions, ensuring smooth execution and delivery of medical programs, including research, and delivering on key performance indicators for efficiency and effectiveness.
• Develop and lead the MAF budget planning process, optimizing resource allocation to achieve high-impact, cost-effective programs;
• Provide input & oversight to development of finances, timelines, and other project management related objectives.
• Lead Medical Excellence and the development and execution of key Medical Affairs processes such as Medical Affairs Launch Readiness and Congress Planning
• Drive a culture of continuous improvement, seeking innovative ways to optimize processes and systems. Further change management initiatives, where appropriate.
• Build and maintain strong relationships with external vendors, supervising purchase orders, spend management, and tracking key performance indicators.
• Establish and monitor quality assurance processes to maintain the highest standards and compliance for Medical Education Programs, clinical trials, IIS/RWE and KOL engagements (advisory boards, Round Tables, Multichannel, etc.).
• Identify and mitigate potential risks related to MAF operations/programs, developing contingency plans when necessary.

Qualifications

• Bachelor’s degree is required; Advanced degree (ex. MBA, MS, PhD or PharmD) is strongly preferred.
• PMP certification or the equivalent Project management training completion is preferred.
• Minimum of 10 or more years working within the pharmaceutical or related industry is required.
• Experience in management of external partnerships and alliances preferred
• Experience in financial planning and budget tracking is required.
• Demonstrated success leading teams is required
• Direct people management and coaching experience preferred
• Demonstrated track-record of team collaboration and understanding insights/analytics with translation into overall business strategy is required
• High proficiency with AI, Excel (generating tables and graphs) and Power Point is required
• Strong oral and written communication skills is required
• Technical competencies in SharePoint, Ariba and other information technology systems are highly preferred.
• Must be timely, results oriented, and able to think creatively, critically, and proactively, with strong problem-solving skills is required
• Self-starter mentality with a strong sense of ownership and ability to multi-task in a fast-paced environment is required

This position will be located in Titusville, NJ and will require up to 15% travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  ([email protected]) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Requirements Analysis, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Product Strategies, Stakeholder Analysis, Strategic Thinking, Workflow Analysis

The anticipated base pay range for this position is :

$164,000.00 - $282,900.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits