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Associate Director, Regulatory Affairs
3 months ago
Company Description
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating BT8009, a Bicycle Toxin Conjugate (BTC ) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA ) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radio Conjugates (BRC) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.
Culture is key and all Bicycle employees actively embrace and role model our company values:
- We are Adventurous . We believe it’s the way to deliver extraordinary results for our patients.
- We are Dedicated to our Mission . You can’t change the world if you don’t have determination.
- We are One Team . We only succeed when we work together.
Job Description
The Associate Director of Regulatory Affairs will be responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects.
The Associate Director Regulatory Affairs will be responsible for oversight of the operational execution of Regulatory submissions for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues. As an integral member of the team that will be tasked with product development, the Associate Director Regulatory Affairs will also serve as a subject matter expert (SME) for assigned development programs, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
- Responsible for the development and execution of regulatory strategy for assigned BicycleTx programs or projects, including development and maintenance of the Regulatory Plan, working with the Director of Regulatory Affairs and other colleagues as appropriate
- Oversee the preparation and execution of global regulatory submissions for assigned BicycleTx programs or projects, in collaboration with the Regulatory Lead.
- Responsible for the maintenance of regulatory files and tracking databases, including relevant parts of the trial master file
- Collaborate with internal colleagues, external regulatory and quality consultants, and external organizations, to support the timely execution of regulatory submissions, authoring of responses to questions, audits and inspections
- Manage the preparation, drafting, review, risk analysis and mitigation planning of submissions for assigned BicycleTx programs or projects, which may include some strategic submissions such as INDs, CTAs, NDAs, MAAs, pediatric plans, orphan drug designations and/or expedited program submissions, etc.
- Monitor the regulatory landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects
- Develop and maintain internal cross-functional relationships to support the development and execution of regulatory strategy assigned BicycleTx programs or projects
- May act in collaboration with the as Global/Regional Regulatory Lead for assigned development programs
- May serve as primary contact with Health Authorities (HA) &/or external collaborators globally for assigned BicycleTx programs or projects.
- May support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities
- May support preparations and attend regulatory authority meetings for assigned development programs
- Partner with the Director Regulatory Affairs to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic-specific issues
- Maintain oversight of current and pending relevant regulatory approvals
- Maintain working knowledge of laws, guidances and requirements relevant to assigned BicycleTx programs or projects, in addition to general regulatory knowledge
Qualifications
- Bachelor’s degree in a scientific field or post-graduate degree preferred
- Extensive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
- Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
- Experience and knowledge in preparation of INDs, CTAs, NDAs, MAAs or regional equivalents is required
- Experience and knowledge in the supportive interactions with health authorities, including US FDA, EMA and/or EU Member States, is desirable
- An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required
- Experience and knowledge of some of the key regulatory pathways for product development, for example pediatrics plans, orphan drugs, Regulatory Agency advice, expedited development (e.g. Fast Track, Breakthrough Designation, PRIME) is desirable
- Therapeutic experience in oncology is desirable
- Ability to communicate on topics of basic science is essential; a working knowledge of global drug development including preclinical & clinical is required
- Ability to proactively identify risks and develop risk mitigation strategies
- Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions, and adapt to changing priorities and deadlines
- Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity
- Works proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projects
- Works effectively in a highly complex and fast-paced environment
- Strong organizational and time management skills
- Position may require some domestic and international travel
Additional Information
- Flexible working environment
- Competitive reward including annual company bonus
- Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
- Health and Dependent Care Flexible Spending Accounts
- 401(k) plan with a 4% Company match and immediate vesting
- Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
- Employee assistance program
- Employee recognition schemes
- 10 Company holidays
- Competitive Family Leave Policy
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
All your information will be kept confidential according to EEO guidelines.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
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