Dewpoint Therapeutics is building a highly collaborative team to harness the power of biomolecular condensates. Together, we are leveraging a transformative shift in the understanding of cellular biology to discover and advance breakthrough therapeutics for the toughest diseases.
We are searching for a Head of Translational Medicine to build a Translational Medicine Organization and lead the overall strategy, planning, and execution of translational medicine activities, regulatory affairs, and early clinical trial design across diverse disease areas. Reporting to the Chief Scientific Officer, you will be responsible for championing and overseeing the work of translational medicine across all stages of drug development and building cross-functional clinical development teams with expertise across disease areas to develop clinical trial designs. The ideal candidate is a strategically minded, translational medicine and early clinical development expert with the responsibility for transitioning projects from research into clinic development, and for the translational and early clinical development strategy for specific diseases. You would have a mix of strong disease knowledge, cutting edge science, and enough early development experience to be able to be autonomous when driving programs into the clinic and through the regulatory process.
In this position you’ll be part of highly collaborative, international, multi-disciplinary team, working in an energizing and supportive startup culture engaged in continuous learning. This role is based at our site in Boston's Seaport district and there is some travel, including international travel, expected 10%-20% of the year. Dewpoint offers competitive salary and benefits.
In this role you will…
- Collaborate with colleagues across the R&D organization to foster an end-to-end view of drug development, with a focus on improving patient care
- Build a Translational Medicine strategy & organization to oversee translational medicine, early clinical development, and early regulatory affairs across a range of disease areas in a rapidly growing biotechnology company
- Coordinate with and direct CROs as needed to achieve drug development objectives
- Provide medical leadership and translational medicine expertise on cross-functional Project Teams
- Provide clear and timely communication and interpretation of study results to department and organizational governance, functional area experts, and development review committees
- Engage with external academic and industry partners in planning and executing strategy and clinical studies
- Engage with external scientific and medical experts to bring insight to development programs
- Develop early clinical development plans that are innovative, safe and create a foundation for decision making
- Be responsible for Phase 0, First-in-Human, Proof-of-Mechanism and Phase 1 studies throughout development, including validation of innovative clinical biomarkers to support decision making
- Interact and mentor teams of multidisciplinary discovery scientists, working on early biology, to translate their findings and understanding into highly impactful drug discovery programs
- Be a critical element in Dewpoint’s approach to create an effective bridge between discovery research and clinical development
- Become a valuable contributor to other initiatives as they arise in our fast paced, startup environment
To do that you will need…
- MD or MD/PhD and at least 15+ years of broad bio/pharmaceutical industry experience in drug development, coupled with at least 5+ years of experience of leading projects in industry from translational medicine to clinical development
- Strong record of basic and/or translational research productivity
- Early clinical development experience in an industry setting
- Experience with first-in-class clinical trial design, patient selection, regulatory discussion, and a programmatic approach to learn about a new mechanism in the clinic
- Expertise in, or ability to build a team with expertise in, Neuromuscular diseases, Cardiopulmonary diseases, Oncology, and Virology, with at least some experiences that range from Discovery through Clinical POC
- Proven experience leading teams in the development of specific small molecules through preclinical development, IND filing, and initiation of clinical trials
- Demonstrated ability to lead others through change by navigating ambiguity, creating the context, and engaging individuals
- Proven ability to effectively build alliances across functions, based on end-to-end drug development thinking and experience
- Ability to collaborate in a multidisciplinary and dynamic environment and experience in working directly with scientific teams
- Ability to communicate effectively in English, the shared language of our multicultural team
Dewpoint is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Please, no solicitations by agencies.Apply