Senior Director, Clinical Operations US

Summary:

Reporting to the Head of Clinical Operations, the Senior Director, Clinical Operations US will oversee and manage North American clinical operations activities as well as supporting clinical operations oversight for a global phase 3 registrational trial in HD and a US phase 2 trial in ALS. One main area of focus is managing complex vendor relationships to prevent, identify, escalate, and solve any obstacles, ensuring the trial is executed according to plan. This position is multifaceted requiring strong analytical abilities, strategic thinking leading to quick and thoroughly thought-out actions, as well as flawless execution.

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Roles and Responsibilities:

• Oversee and manage Prilenia’s clinical operations activities in North America to ensure trial success and compliance with quality standards (SOP’s, GCP etc.). This includes but not limited to North American supervision of a Global Phase 3 registrational trial involving multiple CROs and complex vendor relationships.

• Work with the CRO and North American PI and Co-PI to effectively support the clinical sites as needed (e.g. provide information about the drug, escalate and solve problems) and communicate with them on behalf of the Company

• Support global clinical operations under the supervision of the Head of Clinical Operations. This could include taking on various tasks from big to small e.g. oversight of monitoring visits and review of monitoring reports, data management oversight (including review of study documents), contribute to study plans, trial budget oversight.

• Take on other clinical development projects as required.

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Who are we looking for:

• BSc/MSc in scientific/clinical/medical field

• 10 years of experience in clinical operations roles in biotech/pharma including 3+ years as a Director

• In depth knowledge of FDA regulations, GCP and ICH guidelines and ability to translate this into SOP’s and other processes

• Experience in effectively managing clinical trial teams which include multiple vendors

• Recent experience overseeing global registrational clinical trials with demonstrated success

• History of building relationships and managing complex CRO contracts including delivering feedback and holding others to timelines and deliverables while maintaining strong professional relationships

• Demonstrated history of conducting remote oversight/supervision effectively

Required Skills & Experience:

• Record of effectively meeting timelines and milestones in fast-paced, high-capacity, versatile and energetic environments while managing multiple parallel assignments with sense of urgency

• Strong strategic planning, and decision-making/problem-solving skills; sometimes with incomplete information or unexpected information in compressed timeframes

• Reputation for working at multiple levels, engaging with senior leadership on clinical development strategy as well as conducting study level work with flawless execution

• Track record of thriving and adapting to ambiguity and a rapidly changing work environment

• Outstanding listening, verbal, written and presentation communication skills; success translating and clearly communicating novel, complex messages to variety of internal (executives) and external stakeholders

• Reputation as both a leader and as a “hands-on” team member, demonstrating value of collaborative culture over individual contribution

• Experience effectively working remotely with globally and remote teams

• Skilled at succeeding in a dynamic, entrepreneurial company with limited resources and highly matrixed decision making and operating model

• Record of adopting and working with new IT systems and programs (e.g. company and CRO systems)

Location:

The Boston area with remote work arrangements until conditions allow to return to the office.

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Full time position; Requires frequent (~30%) travel within North America (mostly to clinical sites) when circumstances allow, as well as some international travel.

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If you wish to apply for this position, please email your CV to careers@prilenia.com

Medical and Safety Director, US/Netherlands

Summary:

As the Medical and Safety Director will be responsible for the company’s medical and safety monitoring for all of our active programs (including two upcoming potentially registrational trials in HD and ALS), as well as managing and contributing to general clinical and medical activities of the company. Working closely with other Prilenia team members globally, the Medical & Safely Director will also play a significant role in working with external KOLs, CROs and other stakeholders. 

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Roles and Responsibilities:

•  Lead the Company’s medical and safety activities, working closely with management and external advisors and consultants. These activities may include but are not limited to:

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• Establish and lead the Company’s safety monitoring and pharmacovigilance practices. These activities may include but are not limited to:

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• Play a role in the company’s clinical, medical, safety and regulatory strategy:

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Who are we looking for:  

• MD degree required

• Minimum 4 years drug safety, clinical research, or healthcare related experience including clinical trials adverse event reporting 

• Minimum of 4 years pharmaceutical industry experience 

• Detailed knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments 

• Experience with clinical study design, regulatory submissions and interactions 

• Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail

• History of successful collaboration and execution in a global team environment

• Record of analyzing and interpreting data and developing written reports and presentations of those data

• Strong and analytical thinking skills

• Strong interpersonal skills, self-driven, hands-on mentality, with strong problem solving, scientific, critical, strategic and analytical skills

• Excellent verbal and written communication skills, including strong formal presentation skills 

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Location:

The position will be based either in the US East Coast or the Netherlands and may require ~30% travel. ​

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If you wish to apply for this position, please email your CV to careers@prilenia.com

o    Medical and safety oversight of active trials
o    Monitor study progress, ensure proper study conduct and adherence to the protocol, participate in data 
       review, evaluation, and analyses in collaboration with clinical operations and other internal and external
       functions
o    Provide medical input and contribute to the clinical development sections of regulatory documents such as
      Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding
      questions about complex clinical development issues (e.g., safety or efficacy)
o    Ensure that Serious Adverse Events are properly reported on a global basis.
o    Lead major reports and clinical/medical/safety documents preparations (e.g. IB, DSUR, clinical reports)
o    Facilitate the company’s response to clinical/medical/safety questions from Regulatory Authorities and
      IRBs

o    Develop the integrated safety database
o    Oversight of CRO pharmacovigilance activities including medical monitoring and safety reports, SAE
       coding and narratives etc. 
o    Develop and maintain Reference Safety Information (RSI) 

o    Provide medical input for clinical trials in various stages, including registrational, managing the process
       from protocol development through study execution to completion of study reports and integrated
       regulatory documentations
o    Contribute to regulatory strategy and future submission plans and documents
o    Contribute to strategic clinical development plans 
o    Participate in clinical meetings and presentations