Clinical Scientist Senior Director

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. The Company 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:Biomedicines was founded in 2018 by Flagship Pioneering and has received over $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

We are seeking a highly motivated and detail-oriented Clinical Scientist, Senior Director to join our Research & Development team. The Clinical Scientist will play a critical role in the execution and management of Phase 1-3 clinical trials for our biologic drug candidates. This position involves close collaboration with cross-functional teams, including Clinical Operations, Medical Monitors, Clinical Pharmacology, Safety, Translational, Biometrics and Regulatory Affairs. The Clinical Scientist will also contribute to the development of clinical documents, including protocols, study reports, and regulatory submissions. The role will report into the VP of Clinical Development.  

Here's how you will contribute:

• Participate in the design and implementation of Phase 1, 2, and 3 clinical trials, ensuring scientific integrity and alignment with strategic objectives. 

• In some programs, may play the role of Study Manager 

• Play a key role in the set-up and advancement of clinical trials with registrational intent. 

• Collaborate with diverse stakeholders as listed above and external partners (CROs, investigators) to monitor trial progress, ensure protocol adherence, and manage timelines. 

• Assist in preparing and reviewing clinical study protocols, amendments, informed consent forms, and investigator brochures. 

• Provide scientific input during site selection, investigator meetings, and site monitoring activities. 

• Lead and contribute to the preparation of clinical study reports, clinical sections of regulatory submissions (IND, BLA), and other relevant documents. 

• Author personally, and in other cases collaborate with medical writers and contribute to manuscripts, abstracts, and presentations for scientific conferences and publications. 

• Ensure all clinical documentation complies with Good Clinical Practice (GCP) guidelines and regulatory requirements. 

• Serve as a clinical/scientific resource for internal teams and external partners (CROs, regulatory agencies). 

•  Engage with key opinion leaders (KOLs) and investigators to incorporate feedback and insights into trial design and execution. 

• Support the preparation of clinical components for regulatory submissions (e.g., INDs, NDAs, BLAs). 

• In collaboration with colleagues in biometrics and data management, lead activities related to data generation and validation, clinical data review and query resolution 
• Participate in meetings with regulatory authorities to present clinical data and respond to inquiries. 

The Ideal Candidate will have:

• PhD in a scientific field of study and ten (10) years of related experience; or Master’s degree in a scientific field of study and twelve (12) years of related experience; or Bachelor’s degree in a scientific field of study and fifteen (15) years of related experience; or eighteen (18) years of related experience.  

• Hands-on experience with Phase 1-3 clinical trials and medical writing. Experience with clinical operations is a plus. 

• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials. 

• Excellent communication skills, both written and verbal, with experience in medical writing. 

• Ability to work in a fast-paced, dynamic environment with a high degree of independence. 

• Experience with regulatory submissions (IND, BLA) and interactions with the FDA or other regulatory agencies. 

• Experience in small and large companies is preferred but not required. 

• A record of consistent professionalism, particularly when under pressure. 

• Strong organizational skills with an ability to work on multiple projects at various stages, concurrently. 

• High standards for themselves, colleagues and reports. Willingness to have difficult conversations for the sake of advancing company strategy and patient well-being. 
• Open-mindedness and creativity to new methods and bold strategies. 

Location: 

This role will be based out of our headquarters in Somerville, MA. We are able to consider remote US based talent for this position.    

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:

Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster.  The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations.  The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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