Senior Director, Clinical Operations

F-star

Closing Date: 12/11/2021

POSITION: Senior Director, Clinical Operations

LOCATION: UK

DEADLINE: 12/11/2021

ABOUT F-STAR:

At F-star, we are dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. We develop mAb², a novel class of disruptive bispecific antibody-based therapies that have the potential to overcome tumor resistance and restore anti-cancer immunity and responsiveness.

We are committed to delivering life-changing treatments for the estimated 80% of patients with cancer who currently fail to have a durable response to immunotherapies.

Our wholly owned pipeline shows focused and potent immune activation, with a promising safety profile to date.

F-stars research team is based in Cambridge UK with an expanding footprint in the US from our Hub in Cambridge, Massachusetts to support our clinical stage requirements.

JOB PURPOSE:

As Senior Director, Clinical Operations you will be accountable for the successful planning, implementation and conduct of F-star’s clinical trial programs. You will work closely in a leadership capacity with the VP of Regulatory Affairs and Clinical Operations to oversee the delivery of all F-star’s clinical programs, whilst playing a hands-on operational role leading your own program of work in clinical operations. You’ll support and collaboratively lead both line reports and project team members to deliver on the company’s corporate milestones in clinical trial conduct. The core duties and key responsibilities include, but are not limited to:

KEY RESPONSIBILITIES:

• Study Management may include first-in-human and early phase clinical trials through full development programs.

• Manage cross functional leadership and CRO/vendor management related to clinical trial operations aspects.

• Lead in the selection and oversight of CROs and other vendors as required

• Develop and lead the review of clinical outsourcing strategies and plans

• Participate in clinical trial budget management, forecasting and annual departmental budget planning

• Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures

• Initiate and lead monitoring oversight activities are conducted in accordance to F-star and FDA, ICH/GCP standards

• Identification and evaluation of program risks and provision of solutions

• Participate in the design and development of clinical trial protocols and associated documentation

• Line management and mentoring of Clinical Trial Management staff including staff recruitment, resourcing, training, performance management and other management responsibilities.

• Together with other Clinical Operations personnel as required, represent the Company externally to Investigators and trial site administrators

• Prepare and present clinical trial updates to project teams and management including identification of potential issues/risks and providing recommendations

• Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct

• Maintain oversight and participate in the review of departmental SOPs to ensure compliance

• Develop and maintain strong, collaborative relationships with key stakeholders within F-star

PERSON SPECIFICATION:

• A minimum of a bachelor's degree in a scientific or health related field is required

• 12+ years of relevant experience gained in biotech/pharmaceutical/CRO environment

• Global experience in Phase 1-3 trials is required

• Commercial awareness and excellent understanding of the drug development process

• Proven track record and a minimum of 5 years' experience of effective leadership in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

• Experience in oncology is required

• Motivated self-starter who is capable of flourishing in a fast-paced small company environment

• Creative problem solver with excellent communication skills.

• Strong interpersonal, influencing, and organizational skills are needed, with a high degree of attention to detail. Ability to effectively communicate with individuals at all team levels including Executive Management and integrate input from the full range of stakeholders both in and outside the company

• Ability to travel for up to 10-20 % of time, both domestic and international, may be needed.

What F-star can offer you

We get things done, we keep things simple and we’re driven by the science. We’re ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations, team work and perks, which make F-star a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.

Benefits:

• Pension (8% Employer contribution)

• Equity Incentives

• Private Medical Insurance

• Health cash plan

• Life assurance

• 25 days holiday, plus the option to buy 5 days.

• Travel insurance

• Enhanced Maternity, Paternity, Adoption pay

• Flexible working opportunities

For more information and to apply for the position please click here: https://www.cloudonlinerecruitment.co.uk/F-star/Vacancy.aspx