Director, Clinical Development, Autoimmune

About Generate Biomedicines

Generate Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. Generate has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate was founded in 2018 by Flagship Pioneering and has received over $420 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with over 250 employees.

The Role:

Generate is seeking an MD with experience in clinical development of agents in the autoimmune space, with expertise particularly valuable in asthma, atopic dermatitis and/or rheumatologic diseases.  The role requires defining and executing strategy for therapeutic programs ranging from early pre-clinical through to human proof-of-concept studies in collaboration with a cross-functional team.  The candidate will work closely with cutting-edge researchers within Generate who specialize in computational biology, protein sciences and preclinical development.  The successful candidate is self-motivated and energetic, with skills and experience in clinical drug development along with an understanding of basic biology and preclinical drug development.  The role can be remote within the continental United States, or based at Generate’s Somerville, MA headquarters.

Key responsibilities:

• Define and ensure smooth, efficient and high quality execution of clinical development for Generate’s lead asset, due to enter clinic in the fall of 2023.
• Apply creative trial design principals to get therapies to patients in need as swiftly as possible
• Work with cross-functional teams (e.g. computational biology, protein sciences, preclinical drug development, quality, CMC, operations) to define the strategy for additional autoimmune-oriented agents in Generate’s pipeline and to interpret data from preclinical and clinical programs
• Collaborate closely with clinical CRO, investigators and internal team to ensure optimal execution of clinical trials
• Telescope between detailed knowledge of each patient on early phase trials and broader strategy, both within Generate and in the context of the field more broadly. Serve as subject matter expert within Generate for all topics related to molecules under development and related mechanisms and clinical spaces.
• Engage with external stakeholders such as clinical CROs, translational labs, regulators, investigators and key opinion leaders to execute strategy and flex when needed
• Use scientific, operational and interpersonal expertise to solve study and/or project related problems
• Drive development of protocols for clinical studies.
• Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);

Qualifications:

• MD degree and at least 2 years of clinical development experience in industry. Experience in the autoimmune and/or asthma space is preferred.
• Ability to thrive in a fast-paced environment
• Attention to detail, self-motivated, energetic, with a sense of urgency to achieve team and program goals
• Excellent analytical, problem-solving and strategic planning skills
• Clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
• Some experience managing complex projects and working collaboratively with multiple stakeholders
• Firm understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules

#LI-KD-1

Generate Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

COVID Safety:

Generat