Senior Operational Strategy Director

Precision for Medicine; Peapack-Gladstone (NJ); On-site; USD 203,000 - 305,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement plan

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision for Medicine seeks a Senior Operational Strategy Director to lead the operational strategy for global clinical studies, supporting RFPs and bid defense meetings, and aiding post-award activities. You will collaborate with medical, operational, business development, and finance to shape study budgets and timelines.

Ideal candidates have extensive CRO/pharma experience, strong budgeting skills, and a track record in complex trial design and strategy development.

Qualifications

• Approximately 18 years in the CRO/Pharmaceutical industry or equivalent relevant experience.
• Demonstrated competence in operational strategy analysis and budget review.
• Strong experience in clinical development with operational delivery and budgeting.

Responsibilities

• Collaborate with cross-functional teams to develop and refine operational strategy for opportunities.
• Provide data-driven feasibility and country/site recommendations and competitive landscape analysis.
• Develop proposal text describing operational strategy and conduct reviews prior to sponsor delivery.
• Create and refine study budgets in partnership with leadership.
• Support transition of operational strategy ahead of opportunity BDM and post-BDM follow-up items.

Skills

Leadership

Analytical thinking

Budgeting

Stakeholder management

Communication

MS Office

Tools

MS Word

Excel

PowerPoint

Web-based platforms

Job description

The Senior Operational Strategy Director will be a core member of the expert team within Operational Strategy Department of Precision for Medicine. As part of this team, they will drive and support the operational strategy considerations for the RFPs, bid defense meetings (BDMs) and support the operational teams at BDM. This will entail drawing on strong experience of operationalizing complex clinical studies globally, knowledge and analysis of the competitive environment and analysis of the study design and rationale. The Senior Operational Strategy Director will support the business development team by representing Precision operations at pre-award meetings. In addition, this team member will lead specific projects that will enable Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

Essential functions of the job include but are not limited to:

• Collaborate with medical, operational, business development, proposal colleagues and other Precision functional leadership as required to:
  • Create, develop, and refine the strategy for potential opportunities specifically regarding operational considerations such as enrollment, feasibility, study timelines, startup timelines, relevant experience, competitive landscape.
  • Collaborate and work closely with colleagues from Feasibility to provide data driven analysis to support the operational strategy, particularly with respect to country and site recommendations, competitive environment and projected recruitment rate.
  • Develop proposal text that describes the operational strategy and conduct a comprehensive proposal review prior to sponsor delivery.
  • Ensure proposals reflect robust strategic, operational, scientific, medical and clinical development planning.
  • Create and refine study budgets and support the development and finalization of study budgets for potential opportunities in partnership with other functional leadership as necessary.
  • Work closely with colleagues in Project Management and Clinical Trial Management to transition the operational strategy approach ahead of opportunity BDM and support in post-BDM follow up items.
  • Participate in the post award engagement meeting to ensure the study team has the information and rationale behind the strategy position.
  • Mentor and train Operational Strategy colleagues and Precision colleagues in aspects of strategy and budgeting for clinical research.
• Represent Precision for Medicine in client meetings:
  • Support capabilities presentations and client meetings
  • Provide feasibility and competitive landscape direction input, and support for BDMs utilizing software and web-based applications.
  • Create innovative solutions in conjunction with medical and scientific strategy, and provide consulting, as needed, for clients who are seeking input.
  • Work with Precision for Medicine team to support pre-award collaboration and inclusion of translational and data innovation strategies where appropriate, to help optimize Precision impact.
  • Represent the Company by attending industry meetings, speaking engagements, booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals and digital media.

Qualifications:

• Represent the Company by attending industry meetings, speaking engagements, booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals and digital media.

Other Required:

• Approximately 18 years in the CRO/Pharmaceutical industry or equivalent relevant experience and/or demonstrated competencies.
• Demonstrated competence and relevant experience in the required activities for the role including operational strategy analysis and budget review.
• Strong experience in Precision’s identified target therapeutic area clinical development focused on operational delivery considerations, strategy, feasibility, budget development and operational execution of all phases of clinical trials

Preferred:

Skills:

• Proven leadership and organizational skills
• Strong oral and written communication skills
• Strong rationale and analytical thinking.
• Strong ability to develop and review study budgets in alignment with study delivery strategy.
• Active listening and strong presentation abilities.
• Able to collaborate with diverse stakeholders.
• Strong computer skills, specifically with MS Word, Excel, PowerPoint, and with web/data-based platforms.
• Exceptional analytical and problem-solving skills
• Highly organized with excellent interpersonal, presentation, oral and written communication skills
• Strong sense of ownership and pride in quality of outputs.
• Strong attention to detail.
• Ability to multitask to tight timelines prioritizing workload and maintaining high quality standards.
• Willingness to work in a matrix environment, work independently and as part of a dynamic team.
• Accomplished at maintaining a sustained focus at the macro level while being able to manage at the micro level as needed.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective in delivering results with appropriate quality and timeline performance.
• Numeric and financial management skills.
• Embraces and embodies the established Precision for Medicine’s Cultural Values as an underlying tenet to drive work behaviors.
• Demonstrates mastery knowledge of ICH-GCP, relevant Precision for Medicine’s SOPs and regulatory guidance.
• Ability to work as part of a team.

Travel Required:

• Domestic and international travel including overnight stays.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$203,200 - $304,800 USD

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail] .

Candidates must be legally authorized to work in the country of employment without employer sponsorship.