Executive Director, Clinical Development

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 over 275 employees.

The Role:

Are you ready to take a pivotal role in shaping the future of clinical development? We are seeking an experienced and dynamic Executive Director to join our Clinical Development team. In this leadership role, you will partner closely with the SVP, Clinical Development in spearheading our clinical development plans, drive strategic initiatives, and lead our early clinical programs to meet critical clinical endpoints.

As the Executive Director, Clinical Development, you will have the opportunity to lead groundbreaking clinical programs, using our proprietary platform, that have the potential to transform the lives of patients worldwide. With a focus on diverse disease populations, your contributions will be integral to bringing transformative treatments to market. You will play a key role in developing our clinical strategy, guiding our programs from inception to successful execution. Your expertise will be crucial in developing protocols, authoring critical study documents, and ensuring adherence to Good Clinical Practice (GCP) standards. We are open to hybrid (remote US based talent) for this role.

Here's how you will contribute:

• Accountable for clinical development plans and overall clinical strategy; serve as program lead in internal and external interactions, championing programs and positioning them for success
• Contribute to development of protocols and other critical study documents (Statistical Analysis Plans, Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
• Facilitate the conduct of clinical trials by:
• Developing and maintaining excellent working relationships with investigators
• Delivering high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
• Providing guidance and/or training for external personnel/parties involved in company clinical studies to ensure subject safety and adherence to the protocol and good clinical practice (GCP)
• Identify emerging risks and manage them with the team as appropriate
• Mentor the project team, including any clinical scientists and project team leaders directly or indirectly reporting to this position, and provide clinical education support for internal company customers.
• Interpret clinical data and author clinical study reports (CSR).
• Lead clinical strategy for regulatory submissions, responses to regulatory questions and presentations at regulatory meetings.
• Interact with regulatory agencies, in concert with the Regulatory Affairs Department, to develop novel and efficient clinical programs in both rare and common disease populations.
• Establish external medical/scientific advisory teams and interact with thought leaders and clinical investigators in the therapeutic area to prepare/revise/maintain and efficiently execute the drug development plan.
• Support publication strategy of clinical data through preparation and submission of clinical findings to scientific journals and conferences.
• Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams.
• Assist in accomplishing department and corporate objectives.
  
  

The Ideal Candidate will have:

• Ph.D. and/or M.D. with biopharmaceutical industry experience of 15+ years in leading clinical development for early- and mid-stage therapeutic programs.
• Demonstrated leadership, organization, and excellent written and verbal communication skills.
• Ability to work collaboratively in a fast-paced, team-based matrix environment.
• Demonstrated record of designing, planning and executing clinical studies.
• Demonstrated record of strategic development planning, leadership and decision-making resulting in successful outcomes.
• Elevated interpersonal and communication skills with ability to flexibly relate to both internal and external stakeholders. Ability to develop strong collaborative relationships with colleagues across all functional areas.
• Experience providing leadership and guidance to project teams
• It is imperative that this individual operate successfully both at a strategic level as well as in an operational, hands-on capacity. The latter requires a practical, can-do and time-conscious approach that is motivated by the need to do the things today that strategic plans indicate will get a transformative treatment to patients in the future.
• Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and getting work done efficiently
• A proactive ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
• Attention to detail and quality while also being aware of the need to make timely decisions and to execute
• Growth/ (or innovative) mindset and desire to work in a fast-paced dynamic environment and collaborate openly with others
• Proven excellence in development and leadership of a cross-functional clinical program team
• Patient-first attitude in trial design and execution
  
  

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.