Director, Clinical Operations

POSITION SUMMARY:

This director level position oversees and is responsible for all aspects of clinical development, including clinical research, operations, safety, and portfolio planning. The Director oversees vendor relationships, site selection and management, and contract and budget negotiations. This position will serve as a member of the Clinical Therapeutics leadership team and will provide input in developing the department's overall strategies, budgets and plans.

DUTIES AND RESPONSIBILITIES:

• Supervise and manage the internal clinical team
• Participate in designing and writing clinical trial protocols
• Manage clinical site selection, trial agreements, and budget negotiations
• Selection and management of vendors required for the conduct of clinical trials (e.g., Clinical Research Organizations, central labs, central Institutional Review Boards, analytical labs, etc.)
• Negotiate vendor contracts and budgets throughout the lifecycle of clinical trials
• Conduct investigational product forecasting and management
• Design, review and approve ancillary forms
• Review and approve clinical study documents including SAP, EDC design, validation specs, edit specs, annotated CRFs, shell and final tables, figures and listings, clinical study reports, etc.
• Collaborate with Executive Director, Clinical Therapeutics regarding IP formulation, manufacturing schedule, stability programs, etc.
• Provide Investigational Brochure input
• Manage relevant aspects of compassionate use program
• Performs other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

• Bachelor's degree or higher in Science or Business
• Minimum of 12 years of experience in clinical operations, vendor selection and management, budget and contract management
• Desirable to have at least 4 years of experience in a services organization and preferably at a Pharmaceutical or Biotechnology Company or contract research organization
• Minimum 6 years of direct or indirect supervisory experience (e.g., managing cross-functional teams)
• Experience in life sciences, GXP, government contracting or other regulated industry desired
• Experience with submissions of Investigational New Drug (IND) applications and New Drug Applications (NDA)

KNOWLEDGE, SKILLS AND ABILITIES:

• Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem-solving.
• Ability to work effectively in a fast-paced, high-energy, demanding and deadline driven environment.
• Strong leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
• Ability to provide day to day guidance/mentoring to others in a consistently supportive and collaborative approach.
• Ability to build/foster relationships by reinforcing trust and respect, and demonstrating high standards of tact, diplomacy and discretion.
• Excellent oral and written communication and interpersonal skills and ability to work well with personnel at all levels.
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data.
• Effectively communicate performance goals and expectations to staff.
• Proficiency in MSD Office Suite; MS Project experience.

PHYSICAL DEMANDS:

While performing the duties of this job, the individual is frequently required to sit and stand for long periods. The individual is occasionally required to walk, and may be required to travel from time to time.

WORK ENVIRONMENT:

This job is performed in a traditional office environment.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $151,400. to $236,600. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO/AA STATEMENT

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit here.

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