Reporting to the Chief Operating Officer, this role will be responsible for building, developing, and managing the infrastructure to support advanced clinical trials. This leader will be deeply experienced in managing products from pre-clinical through all clinical phases and product launch. They will select, develop, and evaluate personnel to ensure the efficient operation of the function. The ideal candidate has been heavily involved in building and running the operations in clinical organizations and has had significant hands-on experience with clinical trial management, protocol writing and site evaluation and monitoring.
We are looking for a strong leader with the ability to work collaboratively and self-sufficiently as needed and is willing to build our clinical organization from the ground up. This is a unique opportunity for an experienced professional to apply their expertise and with great autonomy.
Internal Team Leadership: Hire and manage a team to shepherd multiple programs through the clinical process, including both pre-clinical programs to late-stage programs.
Adherence to Scientific Rigor: Ensure that the teams, vendors, and business partners are holding the highest scientific rigor throughout the clinical process. This includes ensuring that all studies are conducted in adherence to accepted legal and ethical standards and pharmaceutical guidance.
Contribute to Drug Development Strategic Plans: Utilizing both prior experience and current program results, help to create and adapt the drug development strategic plans. Manage the implementation of the strategic plans from building the teams, RFPs, vendor selections and budget management.
Communicate Findings: Effectively and efficiently communicate data and findings from each program to the leadership team and other key constituents and use that information to help shape and adapt the future drug development strategic plans.
Risk Mitigation: As problems arise that jeopardize any timelines or budget adherence, develop contingency plans to adapt to changes effectively and efficiently. Apply learned risk mitigation to future projects to ensure that those same issues do not arise.
Education: MS, PhD, PharmD or MD (preferred)
Experience: 15-20 years of hands-on experience in clinical operations (preferred)
Position Location: Carmel, Indiana office
Compensation and Benefits: Competitive base salary, annual incentive bonus and company stock options. Package details based on qualifications and track record of performance.
Competitive benefits package including health, dental, vision, life insurance and 401K. Schedule flexibility and Competitive paid time off
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals, Inc., is a privately held company with offices in Charlottesville, VA and Carmel, IN. Acumen is developing targeted therapies for the safe and effective treatment of Alzheimer’s Disease and related neurodegenerative diseases. Acumen’s lead program, ACU193, is a monoclonal antibody which binds to amyloid beta oligomers which are widely acknowledged to be major mediators of Alzheimer’s Disease pathology. Acumen plans to initiate human clinical studies of ACU193 in 2021 and is seeking to add key contributors to support the development of ACU193 and the growth of the company.
Equal Employment Opportunity
Acumen Pharmaceuticals provides equal employment opportunities to all employees and applicants in all company facilities without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and/or intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, or sexual orientation in accordance with applicable federal, state and local laws.
Accommodation of Disabilities
Acumen Pharmaceuticals is committed to making every reasonable effort to accommodate an employee’s disability. An accommodation may be provided if the employee can perform the essential duties of the job, and it does not create an undue hardship for the company. A reasonable accommodation may include changes in the work environment or in the way a job is performed, so a person with a disability may enjoy equal employment.