Careers: Join Our Team

 
Position Summary:

 

The VP of Clinical Operations is responsible for leading the overall planning, oversight and execution of Ancora Bio’s clinical trial programs in all phases of clinical development (I-III). This will include complex strategic planning as well as planning for on-time, on-budget, efficient trial execution. The VP of Clinical Operations is responsible for staffing plans of the Clinical Operations team and will work with the internal Ancora Bio team as well as all strategic partners and CROs.

Position Responsibilities:

Primary responsibilities for this role include:

  • Clinical Operational Planning and Collaboration: Collaborate with the Ancora Bio team to strategize and plan the clinical trial program(s) across therapeutic areas. Develop the clinical operations framework for Ancora Bio. Assess the staffing needs and assign appropriate leaders for each clinical program. Partner with and maintain regular contact with key stakeholders including Leadership, Medical, Regulatory Affairs, Quality Assurance, Legal, Finance, CMC, Safety, and Program Management.

  • Partner Collaborations: Drive the establishment of key strategic partners across Ancora Bio based on phase, budget and timelines for clinical development. Manage the relationship with our external partners, ensuring that the interests of the company is protected.

  • Program Execution and Oversight: Oversee the tactical implementation of the clinical development plan for all assigned clinical programs, managing the site contracts, budgets, timelines, clinical trial vendors, CRO resources, patient enrollment and site activities. Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and timely completion within budget. Attend partner and vendor meetings to ensure alignment and achievement of study goals.

Position Qualifications:

  • BA/BS in science (e.g., biology, chemistry, pharmaceutical sciences)

  • Pharmaceutical industry experience (minimum 10 years) guiding new drug clinical development/operations program for both small molecule and biologic drug candidates

  • Strong leadership skills with ability to be hands-on and lead/ manage the clinical program

  • Thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines

  • Success identifying, negotiating and overseeing outsourced clinical operations services and vendors

  • Strong track record in effectively working with senior management

  • Proven ability to work collaboratively internally and externally, with the ability to manage multiple stakeholders

  • Results oriented and self-assured. Ability to push timetables while keeping the team motivated

Company Overview:

 

Ancora Bio is a neuroscience focused biotech portfolio company of Aditum Bio, the biotech investment firm co-founded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman. Ancora Bio is a portfolio company focused on neuroscience, with a Phase II ready asset in treatment-resistant depression. The company was formed following the successful in-licensing of a selective vasopressin 1b receptor (V1b) antagonist (ANC-501) from Taisho Pharmaceutical Co., Ltd. At Ancora, we are: patient centric, collaborative, curious and courageous.

Aditum Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.