Generate Biomedicines, Inc.
Executive Director, Clinical Pharmacology
Generate Biomedicines, Inc., Somerville, Massachusetts, us, 02145
Working together toward
limitless possibilities.
Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.
We are differentiated in the composition of our team, which includes individuals from all areas—science, technology, and business—who share apioneering mindset, and are passionate about finding better ways to create medicines for patients.
We seek diverse perspectives because we believe that engaging in candid, productive conflict around ideas is how we will push the boundaries of the possible. Executive Director, Clinical Pharmacology Remote- US 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 nearly $700 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role: As Generate:Biomedicines transitions into late-stage development and prepares for global regulatory interactions, we are seeking an Executive Director of Clinical Pharmacology to lead strategy and execution for global Ph2/3 studies. Reporting to the Head of Clinical Pharmacology and working closely with the Head of Clinical Development, this role will drive the clinical pharmacology vision across our pipeline, with a strong focus on respiratory indications and global regulatory alignment. Here's how you will contribute: Act as the subject matter expert for regulatory agency interactions on clinical pharmacology topics, including INDs, BLAs, and pediatric plans. Design and oversee modeling and simulation efforts to support decision-making and regulatory submissions. Lead the development of global PK, PK/PD, exposure-response related strategies, ensuring alignment with expectations in key regions including the US, EU, China, and Japan. Collaborate closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to optimize clinical trial design and endpoints. Drive pediatric strategy including iPSP/PSP development and regulatory engagement. Guide bioanalytical strategy and ensure data integrity across internal and outsourced activities. Provide clinical pharmacology oversight across development stages Leadership Responsibilities Build and lead a high-performing clinical pharmacology function with strong cross-functional influence. Mentor and develop scientists, fostering scientific excellence, accountability, and collaborative innovation. Champion transparency, adaptability, and urgency to meet program and regulatory milestones. The Ideal Candidate will have: 12+ years of experience in clinical pharmacology within biotech or pharma, including late-stage development and global regulatory interactions.. Top talent with less years of required experience will be considered at the Senior Director level. Proven track record leading clinical pharmacology deliverables in regulatory agency engagements, including FDA, EMA, PMDA, and NMPA. Strong background in pediatric development and regulatory submission planning. Deep expertise in PK/PD modeling and simulation, with demonstrated impact on program strategy. Experience supporting respiratory indications preferred. Excellent written and verbal communication skills, including authoring and defending regulatory documents. Education PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field. Nice to Have (Optional) Prior experience in a fast-growing or first-to-market biotech environment. Familiarity with combination products or complex biologics. Working knowledge of bioanalytical methods and data review. Why Join Us Join Generate:Biomedicines and play a critical role in bringing pioneering respiratory medicines to patients worldwide. You’ll shape global clinical pharmacology strategy and help define the path for first-in-class medicines powered by generative biology. Equal Opportunity Employer Statement 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. 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. #LI-RT1 #L##I-RT1 Compensation:
The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $238,000 - $357,000 USD Create a Job Alert Interested in building your career at Generate Biomedicines? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School Select... Degree * Select... Address Line 1 * Street address Address Line 2 * street address continued City * The city in which you reside State * Select... The State within the United States in which you reside Postal Code * Are you legally authorized to work in the United States? * Select... Do you now or will you in the future require sponsorship to work in the U.S.? (e.g., H-1B, O-1, OPT, etc)? * Select... If you'll require the company to commence ("sponsor") an immigration or work permit case in order to employ you, either now or at some point in the future, then you should select Yes. Otherwise, select No. Are you able to work in the specified job location, or are you willing to relocate for this position? * Select... Do you hold a PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences or related field? * Select... Have you supported clinical pharmacology deliverables for Phase II or Phase III program? * Select... Have you been involved in regulatory interactions with FDA, EMA and other global agencies * Select... When are you able to start a new position? * How did you hear about this job? * Select... If other, please share source LinkedIn Profile Website What geographical area do you live in? * Select... Demographic Questions At Generate Biomedicines, we value belonging and believe in fostering an environment where a diversity of perspectives can thrive. This core value is a pillar of our business and critical to our success. Your responses will be used (in aggregate only) to help us identifyareas of improvement in our process. Your responses will not be associated with your specific application and will not
in any way be used in the hiring decision. Completion of the form is entirely voluntary . How would you describe yourself as male, female, and/or transgender? (Select all that apply) Select... Which of the following best represents how you think of yourself? (Select all that apply) Select... How would you describe your race? (Select all that apply) Select... Are you of Hispanic, Latino, or Spanish origin? Select... Have you served on active duty in the U.S. Armed Forces, Reserves, or National Guard? Select...
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limitless possibilities.
Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.
We are differentiated in the composition of our team, which includes individuals from all areas—science, technology, and business—who share apioneering mindset, and are passionate about finding better ways to create medicines for patients.
We seek diverse perspectives because we believe that engaging in candid, productive conflict around ideas is how we will push the boundaries of the possible. Executive Director, Clinical Pharmacology Remote- US 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 nearly $700 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role: As Generate:Biomedicines transitions into late-stage development and prepares for global regulatory interactions, we are seeking an Executive Director of Clinical Pharmacology to lead strategy and execution for global Ph2/3 studies. Reporting to the Head of Clinical Pharmacology and working closely with the Head of Clinical Development, this role will drive the clinical pharmacology vision across our pipeline, with a strong focus on respiratory indications and global regulatory alignment. Here's how you will contribute: Act as the subject matter expert for regulatory agency interactions on clinical pharmacology topics, including INDs, BLAs, and pediatric plans. Design and oversee modeling and simulation efforts to support decision-making and regulatory submissions. Lead the development of global PK, PK/PD, exposure-response related strategies, ensuring alignment with expectations in key regions including the US, EU, China, and Japan. Collaborate closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to optimize clinical trial design and endpoints. Drive pediatric strategy including iPSP/PSP development and regulatory engagement. Guide bioanalytical strategy and ensure data integrity across internal and outsourced activities. Provide clinical pharmacology oversight across development stages Leadership Responsibilities Build and lead a high-performing clinical pharmacology function with strong cross-functional influence. Mentor and develop scientists, fostering scientific excellence, accountability, and collaborative innovation. Champion transparency, adaptability, and urgency to meet program and regulatory milestones. The Ideal Candidate will have: 12+ years of experience in clinical pharmacology within biotech or pharma, including late-stage development and global regulatory interactions.. Top talent with less years of required experience will be considered at the Senior Director level. Proven track record leading clinical pharmacology deliverables in regulatory agency engagements, including FDA, EMA, PMDA, and NMPA. Strong background in pediatric development and regulatory submission planning. Deep expertise in PK/PD modeling and simulation, with demonstrated impact on program strategy. Experience supporting respiratory indications preferred. Excellent written and verbal communication skills, including authoring and defending regulatory documents. Education PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field. Nice to Have (Optional) Prior experience in a fast-growing or first-to-market biotech environment. Familiarity with combination products or complex biologics. Working knowledge of bioanalytical methods and data review. Why Join Us Join Generate:Biomedicines and play a critical role in bringing pioneering respiratory medicines to patients worldwide. You’ll shape global clinical pharmacology strategy and help define the path for first-in-class medicines powered by generative biology. Equal Opportunity Employer Statement 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. 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. #LI-RT1 #L##I-RT1 Compensation:
The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $238,000 - $357,000 USD Create a Job Alert Interested in building your career at Generate Biomedicines? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School Select... Degree * Select... Address Line 1 * Street address Address Line 2 * street address continued City * The city in which you reside State * Select... The State within the United States in which you reside Postal Code * Are you legally authorized to work in the United States? * Select... Do you now or will you in the future require sponsorship to work in the U.S.? (e.g., H-1B, O-1, OPT, etc)? * Select... If you'll require the company to commence ("sponsor") an immigration or work permit case in order to employ you, either now or at some point in the future, then you should select Yes. Otherwise, select No. Are you able to work in the specified job location, or are you willing to relocate for this position? * Select... Do you hold a PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences or related field? * Select... Have you supported clinical pharmacology deliverables for Phase II or Phase III program? * Select... Have you been involved in regulatory interactions with FDA, EMA and other global agencies * Select... When are you able to start a new position? * How did you hear about this job? * Select... If other, please share source LinkedIn Profile Website What geographical area do you live in? * Select... Demographic Questions At Generate Biomedicines, we value belonging and believe in fostering an environment where a diversity of perspectives can thrive. This core value is a pillar of our business and critical to our success. Your responses will be used (in aggregate only) to help us identifyareas of improvement in our process. Your responses will not be associated with your specific application and will not
in any way be used in the hiring decision. Completion of the form is entirely voluntary . How would you describe yourself as male, female, and/or transgender? (Select all that apply) Select... Which of the following best represents how you think of yourself? (Select all that apply) Select... How would you describe your race? (Select all that apply) Select... Are you of Hispanic, Latino, or Spanish origin? Select... Have you served on active duty in the U.S. Armed Forces, Reserves, or National Guard? Select...
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