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

CMC Senior Manager/Director*, US

Summary:

Reporting to the Head of CMC, the CMC Sr. Manager/Director * will oversee and manage all the pharmaceutical development and GMP production activities from the stage of early development to commercial manufacturing. As the CMC Sr. Manager/Director*  you will work closely with contract manufacturing organizations (CMOs) and will be responsible to ensure that all applicable policies and procedures, including ICH requirements are met. In addition, you will identify, escalate, and solve any obstacles ensuring the clinical supply plan is executed and NDA/MAA submissions are on track.

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*title commensurate with experience

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Roles and Responsibilities:

• Oversee, manage and build relationships with CMOs and CRO counterparts in compliance with quality standards (SOP’s, GMP etc.) including delivering feedback and holding others to timelines and deliverables while maintaining strong professional relationships

• Responsible for ensuring that Drug Product plan aligns with overall development program and supports future NDA/MAA submission

• Support the company’s regulatory submissions including preparation of Drug Product dossier in compliance with International Conference on Harmonization (ICH) guidance

• Write and review of reports, submission documents, master and executed batch records, product specifications and all other documents related to the drug product development, production and test

• Take on other pharmaceutical development projects to support the life cycle management of the pipeline

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Who are we looking for:  

• Educated to B.Sc. or M.Sc. level in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering 

• 5+ years experience in Pharmaceutical Research & Development and product manufacturing in GMP environment; 2+ years as CMC manager

• Track record of managing CMOs in line with contractual deliverables within timelines and budgets

• Experience in Oral Solid Dosage manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.

• Experience in manufacturing process transfer and validation, including understanding and application of required standards and best practices and experience in leading quality/technical risk management activities

• Experience with regulated industry Product Development and Regulatory requirements (knowledge of FDA requirements e.g. cGMP and marketing applications) and ICH guidance affecting drug product development (ICH Q1 to ICH Q14)

• Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment

• Demonstrated experience with regulatory submissions in different markets with emphasis on late stage product development for registration and commercialization

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Skills:

• Fast-paced, high-capacity, versatile and energetic with demonstrated ability to manage multiple parallel assignments effectively with sense of urgency and reputation for meeting timelines and milestones

• A history of strong project management and analytical skills supporting the development and implementation of strategic plans

• Well organized and detail oriented

• Prior history of effectively conducting remote oversight/supervision

• Track record of being successful in ambiguous environments and adapting to a rapidly changing work environments

• Works independently, often under pressure

• Hands-on, flexible and team player

• Outstanding verbal and written communication skills

Location:

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

Full time position; Requires travel within the US (~30-40%, mostly to manufacturing sites) when circumstances allow, as well as some international travel. Frequent calls to Israel and Europe.

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