Director, Project Delivery

35Pharma is a clinical-stage biopharmaceutical company focused on developing best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for pulmonary hypertension, obesity and cardiometabolic diseases. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montreal, Canada, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.

Role:

Reporting to the Vice-President, Clinical Operations, the Director, Project Delivery will oversee the successful execution of clinical trials from study start to the completion of all study closure activities. This includes providing oversight, training, coaching, and mentoring for project managers and other direct reports, developing strategies for geographic reach, site, and vendor selection, ensuring projects are conducted on time and within budget, maintaining high-quality standards, and ensuring compliance with regulatory requirements and industry standards. The Director/Sr Director, Project Delivery will act as a key senior contact for internal and external stakeholders, driving project delivery by promoting and applying innovative thinking within a fast-paced, agile, and collaborative environment.

Key Responsibilities:

• Manage and develop direct reports (e.g., clinical project managers, associate project managers (PMs), managers, TMF Operations, clinical trial assistants, etc.), by leveraging current strengths, experience, and lessons learned, while acquiring new relevant technical and leadership skills when needed. This will be accomplished through providing timely, honest, and constructive feedback, supporting individual growth and empowering teams to excel.
• Establish, consistently track, and report on clinical study metrics and key performance indicators (KPIs) to ensure quality and performance standards are met.
• Review project tasks and timelines, identify and manage resource bottlenecks, and escalate issues effectively and promptly to preserve, meet, and accelerate company goals and project objectives.
• Ensure adequate training and identify professional development opportunities with their direct reports.
• Oversee project management to ensure consistent application of best practices across the team through adoption and use of state-of-the-art processes and tools, in accordance with standard operating procedures (SOPs), regulations, good clinical practice (GCP) and study-specific requirements.
• Must possess and deploy excellent communication and negotiation skills to achieve timely and effective resolution of matters escalated by the PMs with vendors and CROs, presenting solutions to the CMO and to the Vice-President, Clinical Operations, where needed.
• Review project financial health with the PMs and ensure they control costs on studies by helping them identify, track and estimate out-of-scope activities for change orders, and to achieve cost synergies across trials.
• Contribute to developing comprehensive risk management mitigations and contingencies by implementing predictive tools and processes and fostering strong open collaboration with other teams within 35Pharma (Supply Chain, Translational Medicine, CRAs, etc).
• May serve as Project Director and be responsible for the operational management and oversight of a project or program, including the project management deliverables of clinical trials.
• Collaborate with the Senior Director, Clinical Operations, for the development and implementation of standard operating procedures (SOPs), working instructions and policies.
• Provide input in the preparation of requests for proposals (RFPs) for new studies/ expansion of studies, and estimate budgets for new studies/expansion of studies.

Qualifications:

• A minimum of a BSc in health, life sciences, or a related field relevant to clinical project management is required. PMP certification is considered a plus.
• A minimum of 12 years of experience in clinical research (including pharma, CRO, and academia) is required, with direct experience in the biotechnology sector being highly desirable. This should include at least 7 years of combined experience in clinical and project management, and a minimum of 3 years in a leadership role in project management or clinical research.
• Strong strategic, analytical and critical thinking skills coupled with innovative approaches to problem solving.
• Significant experience in the day-to-day management of clinical research staff, including line and matrix management.
• Excellent leadership, judgement, soft and problem-solving skills.
• Ability to prioritize, organize, plan, and successfully execute and lead multiple tasks and priorities simultaneously.
• Strong strategic, analytical and critical thinking skills.
• Excellent oral and written communication skills. (This position involves daily collaboration with suppliers, teams and partners located outside of Quebec, requiring a strong knowledge of English by the candidate).
• Ability to build relationships and establish credibility appropriately.
• A self-starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, agile, and small company environment.
• An unwavering commitment to the highest quality of work, research ethics and willingness to learn.

Please send your CV and cover letter outlining your motivation and relevant experience for the role to quoting "35Pharma Posting DPD1027" in the subject line – we are looking forward to hearing from you

Job Types: Full-time, Permanent

Benefits:

• Commuter benefits
• Company events
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Flexible schedule
• Life insurance
• Paid time off
• Vision care
• Wellness program

Work Location: In person