About Hemab
Hemab is a global, clinical stage biotechnology company focused on re-imagining blood clotting therapies. Based in Cambridge, MA and Copenhagen, Denmark, Hemab is pioneering the first targeted preventative treatments and functional cures for underserved bleeding and thrombotic disorders.
While patients with common bleeding and thrombotic disorders have had access to preventative treatments for more than a half-century, no such measures exist for many patients in need. For these hundreds of thousands of women, men and children, life is paralyzingly unpredictable. A bleeding or thrombotic event can strike any moment, from a simple menstrual period to a routine dental procedure, and cause symptoms so severe that by the time they reach a hospital, it may be too late. It is time to ensure that every clotting disorder patient has the security and peace of mind they deserve.
Hemab’s strategic guidance, Hemab 1-2-5TM, targets the development of 5 assets by 2025 to deliver long-awaited innovation for patients with high unmet need blood-clotting disorders like Glanzmann Thrombasthenia, Factor VII Deficiency, Von Willebrand Disease, and others.
Our program:
The HMB-002 program is advancing a novel antibody to deliver a unique and convenient subcutaneous treatment for patients with Von Willebrand Disease; the most prevalent bleeding disorder in the world. This program is in advanced pre-clinical stage, and the new program leader will see this program through initial regulatory guidance/approval and into the clinic, through Phase I/II studies conducted in a global setting towards pivotal trials.
Program Leader role summary:
At Hemab, all programs entering the IND/CTA enabling phase are managed by a Core Team.
The Program Leader leads this multi-disciplinary program team in an international setting, comprised of functional representatives from research, non-clinical development, clinical development, regulatory, CMC, medical affairs, and commercial to ensure success of the franchise.
The Program Leader serves as a strategic thought partner to the Management Team and is responsible for operationalizing and executing the program strategy.
The Program Leader will ensure that all sub-teams are aware of their overarching objectives, deliverables, and timelines and will drive the program forward according to agreed timelines.
The Program Leader will be responsible for providing a combination of drug development and program oversight to the Core Team and other relevant sub-teams, to maximize the potential of the Hemab assets by ensuring smooth day-to-day operations, enabling timely communications across the teams, and supporting strategic decision-making.
The Program Leader will also coordinate activities associated with global regulatory submissions and launches, as well as life-cycle management planning.
The Program Leader will also be responsible for accurately updating program management reports, timelines and dashboards and drive the identification/implementation of best practices within Hemab.
In this capacity, the Program Leader will call upon direct prior experience to implement proven drug development, commercial, and portfolio best practices and adapt them to the Hemab Operating Model.
Responsibilities:
- Develop and execute program strategy and ensure alignment across all expertise areas
- Hands on development of workplans/timelines and integrated development plans with milestones/goals, key events, risks/assumptions and scenarios
- Drive coordination of cross-functional activities and promote effective communications (e.g., team meetings, meeting minutes, program updates); integration of people involved within the program (e.g., clarity of responsibilities); coordination and co-leadership of critical, defined sub-teams
- Facilitate strategic planning discussions through scenario planning, development of risk mitigation plans, alignment of key program decisions through appropriate forums
- In partnership with the Operating Team and Management Team, ensure clear, timely and substantive updates on program progress
- Manage Core Team meetings, including leading discussions to drive to decision-making, agenda creation, and meeting minutes
- Serve as a key point person for Management Team members, particularly on issue identification, resolution, and escalation
- Owner of key global program documents, e.g., global filing and launch plan, integrated development plan, risk plan, and additional key status and timeline updates
- Provide expertise on program oversight initiatives including alignment of processes, tools, and technologies that aid in portfolio management across the organization
- Perform recruiting activities to help grow the team
- Perform other duties as assigned
- Adhere to Hemab’s core values
Experience and Qualifications
- Minimum of 10 years of experience in biotech/pharma industry in clinical-stage and/or commercial programs
- Experience in advancing programs through initial regulatory guidance/approval and into the clinic, through Phase I/II studies conducted in a global setting towards pivotal trials
- Passion for helping patients and developing transformative treatments for patients in need; motivated by patient focus and personal commitment to high performance and results
- Demonstrated proficiency in program management tools (e.g., Smartsheet, Microsoft Project) and methodology. Willingness to improve project oversight tools and skillset through best practices
- Demonstrated ability to work well in a collaborative, highly networked and dynamic team environment, set priorities, and drive results
- Strong analytical and problem-solving skills; ability to combine attention to detail within broader strategic context
- Excellent written and oral communication, including presentation and facilitation skills
- Thrive in a fast-paced environment with strong ability to handle multiple activities simultaneously across the program and expertise area
- Bachelor’s degree in sciences or related field required; Advanced degree (PhD or MBA) highly preferred
