Director, Site Contracts, Budgets

4 weeks ago

Waltham, United States Deciphera Pharmaceuticals Full time
Job DescriptionJob DescriptionCompany Description

Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas. 

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

  • Patients – places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.
  • Accountability – for our performance and the way we work with coworkers and other stakeholders.
  • Transparency – in our intent and actions to both internal and external stakeholders.
  • Honesty and Integrity – fosters trust and strives to deliver on our and the company’s promises.
  • Stewardship – values and uses wisely the resources and investments provided to the company.
Job Description

The Director, Site Contracts, Budgets & Payments plays key role in operational leadership role in delivering finalized clinical trial agreements and budgets in a timely fashion to ensure clinical trials are started and executed within corporate and Program team timelines.  The Director leads a specialized team of individuals that build and negotiate site contracts and budgets and that are also responsible for the timely and accurate payments made to investigators in accordance to all applicable laws and regulatory guidances.

 

 

The Role:

Responsible for the entire spectrum of activities (both in-house and outsourced) pertaining to clinical trial agreement and budget negotiation and finalization, setting the framework for accurate and timely payments to investigators that are of fair market value, accurate and made timely.

What You’ll Do:

  • Leads the group responsible for developing and negotiating, implementing and executing Clinical Trail Agreements, Clinical Trial Budgets and Clinical Site Payments
  • Manages the vendors responsible for the outsourced activities.
  • Develop and implement the processes and interfaces between Deciphera, CRO, and External Law Firm Consultants for CTAs, amendments, and other related agreements.
  • Ensures all clinical trial agreements executed are of high-quality and checked for consistency for assigned studies between CTA, budget, Informed Consent, and payment requirements.
  • Makes certain that all budget items in Clinical Trial Agreements are within allowed Fair Market Value, and in accordance with Master and Country Level Budgets.
  • Spearheads the process for accurate and timely HCP payments reporting for transparency and compliance purposes.
  • Manages, trains, mentors, and directs direct reports to ensure high-quality and timely deliverables are met for each document and payment made to sites.
  • Prioritizes the work and deliverables as needed.
  • Supervises the creation, generation, implementation and maintenance of performance metrics for department and vendors
  • Approves global site budget escalations that are outside of the CRO negotiation parameters.  Escalates to Legal and/or Compliance Departments as needed.
  • Participates in preparation for and conduct of Health Authority inspections and internal QA audits ensuring that the department operates in a constant state of inspection readiness and in compliance with the FDA, EMA, GCP, and ICH guidelines.
  • Identifies, leads, and participates in process development and process improvement initiatives.
  • Demonstrates excitement around the Vison and Mission of Deciphera and the department.
  • Other duties as assigned.
Qualifications

What You’ll Bring:

  • Bachelor's degree from accredited college or university or equivalent on-the-job experience
  • 3+ year(s) experience in negotiating complex clinical trial agreements
  • Broad knowledge of legal principles and procedures as they relate to clinical trial agreements.
  • Experience in solving multiple and complex challenges through critical thinking and cross-functional collaboration.
  • A practical, business-oriented approach and excellent communication skills with the ability to distill complex legal concepts into simple, actionable recommendations.
  • Proven ability to multi-task, problem-solve and operate in a fast-paced environment.
  • Excellent verbal and written communication skills, strong professionalism and interpersonal and organizational skills while being able to handle multiple responsibilities simultaneously while meeting high quality and timeliness standards under pressure.
  • Sound judgment and commitment to integrity and ethical conduct
  • Strong attention to detail
  • Commitment to developing strong collaborative relationships with other members of the department, clients, vendors, and cross-functional teams.
  • Self-motivated, able to work independently and be reliable and responsive.
  • Ability to be flexible and willing to accept new responsibilities as needed.
  • Commitment to proactively seeking, designing, and implementing improvements and engaging with appropriate stakeholders to propose and implement solutions


Additional Information

What Deciphera will Bring: 

Deciphera offers a comprehensive benefits package that includes but is not limited to the following: 

  • Summer vacation bonus ($500) 

  • Global, company-wide summer and winter shutdowns 

  • An annual lifestyle allowance  

  • Monthly cell phone stipend  

  • Internal rewards and recognition program 

  • Locally customized benefits support program 

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.

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