Company Summary

Hemab Therapeutics is an international privately held, biotechnology company developing next generation prophylactic therapies for people with serious, underserved bleeding and thrombosis disorders.

Hemab launched a $55M Series A financing in July 2021 from blue-chip investors. We have offices and laboratories in Cambridge, MA, USA as well as Copenhagen, Denmark.

The ambition is to progress a strong pipeline of monoclonal and bispecific antibody-based therapeutics that will transform the treatment paradigm for blood disease patients—from orphan disorders to broad indications with high unmet need.

Our lead asset, HMB-001, is a bi-specific antibody that is being developed as a first ever subcutaneous prophylactic treatment for rare bleeding disorders such as e.g. Glanzmann thrombasthenia and Factor VII deficiency (Hemab - bleeding disorder company — Press release on 2nd of Feb). Hemab will begin a Phase 1/2 clinical trial in patients with GT in late 2022 to assess HMB-001’s safety and efficacy.

Our Vision is to Leapfrog biotechnological advancements in clotting for human equality and health and our Mission is to build the ultimate clotting company.

Position Summary

We are seeking a creative, visionary Head of Global Regulatory Affairs to help build the company’s pipeline and transform patient lives through the creation and leadership of a world class development team. The VP, Head of Regulatory Affairs will be part of the company's development team and contribute to the company's vision for developing next generation prophylactic products for people with high unmet need bleeding and thrombosis disorders. S(he) will report to the SVP, Clinical Development and will partner with leaders in research and CMC. The VP, Head of Global Regulatory Affairs will be a key leadership position that oversees and is accountable for worldwide regulatory strategy and execution for Hemab’s various assets. The candidate will provide regulatory leadership and oversight to the development of global regulatory strategies, guidance, and plays a critical role in our interactions with and documents submissions to regulatory authorities. Furthermore, this role leads broadly in a cross-functional and multicultural environment and leverages their extensive experience to represent regulatory affairs in discussions with external and internal stakeholders. This role will provide CMC expertise and contribute to the delivery of the R&D and Operations strategies. The candidate must be an entrepreneurial, highly motivated and purpose driven leader who is able to flexibly and efficiently lead and interact with multi-disciplinary teams within our focus area of bleeding and thrombosis. The successful candidate will have a track record of accomplishments in global regulatory affairs. S(he) must exhibit excellent leadership, project management, and strong collaboration and communication skills. S(he) should be ready to champion new ideas in a very dynamic, international, and innovative environment.

Key Responsibilities

• Provide strategic and technical guidance on critical impact regulatory submissions (e.g. responses to major objections raised by regulatory authorities including product labeling).
• Develop and mentor the team and provide project teams with strategic regulatory guidance to expedite product development, registration, and through life cycle management.
• Impact continued development of regulatory affairs through leadership.
• Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.
• Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management.
• Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible.
• Champion initiatives that contribute to global process improvements, which have a significant impact on business.
• Serve at the ambassador to and develop strategies for responses to CMC-related inquiries from global regulatory agencies to ensure issues are addressed in a timely manner; lead interactions with FDA or other Health Authorities’ as they pertain to CMC.
• Maintain and enhance a network of consultants, vendors, and suppliers to supplement internal capabilities, to adequately support active and future development programs and commercial products.
• Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization’s (CRO’s), material suppliers, consultants, and vendors.

Key Requirements

• Bachelor’s degree in scientific discipline with PhD in science preferred.
• Minimum 10-15 years of progressively responsible Regulatory experience in a pharmaceutical, biotechnology or related environment. Position also requires a minimum of 3-5 years of leadership experience in a global regulatory affairs role.
• Demonstrated expertise in industry regulations and best practices related to CMC regulatory matters.
• Excellent working knowledge of the US, European and Asian regulations for drugs and biologics.
• Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
• Negotiation, influence, and excellent interpersonal communication skills are required.
• Proven ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams in preparation of responses to regulatory questions.
• Proven ability to represent the sponsor in key negotiations with regulatory authorities in the US, EU, and across regions.
• Experience in the preparation and submission of BLA/NDA/MAAs for submission within expedited timelines across the regions.
• Ability to leverage deep regulatory experience in working with the Company’s therapeutics to provide teams with guidance on innovative approaches informed by regulatory precedent and emergent opportunities.
• Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions.
• Experience in the leadership and lifecycle management of products across the Company’s therapeutic areas is desirable.
• Strong interpersonal skills that facilitate collaboration across functions to identify business solutions on regulatory issues.
• Must have extensive knowledge of regulatory requirements, including ICH and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business.
• Must be able to travel (US/international) up to 20%.
• US Citizenship or valid Visa.

Find out how you can leverage your talents and skills to make an immediate impact with us as a team. Learn about how our culture and values provide you with the kind of environment that invites new ideas and innovation. Come see how we collaborate with each other in a culture of learning, coaching, diversity and inclusion. And hear about our unwavering commitment to make a difference in partnership with our communities and colleagues.

What is our culture?

We have a high-performance culture that rewards creative solutions to daily challenges. Hemab offers a good work-life design within the context of a start-up life sciences company.

How much could someone earn in this role?

Our company has a multi-part compensation structure:

• Competitive base salary based on experience
• Every person at Hemab has the ability to share in the rewards of meeting our corporate goals and will be eligible to earn performance-based bonuses.
• We offer a great competitive Total Rewards package which includes health, dental, and vision, as well as other great competitive benefits

For More Information:

Please contact us at info@hemab.com and provide a CV/resume and statement of interest. Also visit us at www.hemab.com

Hemab Therapeutics, Inc. is firmly committed to providing Equal Opportunity Employment.