Are you looking to join an ambitious and people-centric company where you will make an immediate impact on the company’s mission to help people with rare diseases? If so, please read on.
PharmaEssentia Corporation is a fully integrated global biopharmaceutical company delivering efficacious, safe and cost-effective therapeutic products for the treatment of human diseases. Our employees work to develop and deliver important therapeutics, conduct clinical research in areas of unmet need, and create education and support programs for patients. PharmaEssentia products support the health of patients particularly in the areas of hematology, oncology and virology. Central to our core philosophy, we take a people-centric approach through meaningful investment in research and strong commitment to patients and support programs, especially those with unmet medical needs. PharmaEssentia is growing its dedicated and talented team located primarily in Burlington, MA.
Essential Duties and Responsibilities:
Senior Manager, Clinical Operations
You will be an integral member in the planning and execution of clinical trials in myeloproliferative neoplasms (MPNs); manage the operational responsibilities of daily trial activities.
- Serve as clinical operations leader accountable for the development and execution of trials with matrix management responsibility of the clinical trial team.
- Clinical protocol development, protocol feasibility, forecasting and budget management and negotiation, CRO/vendor selection and management.
- Develop and maintain relationships with key stakeholders and co-development partners.
- Preparation of clinical outsourcing specifications and in the follow-up with day to day operational activities with the CROs and vendors.
- Assist in program level activities (e.g., development of clinical sections of regulatory documents like Investigators’ Brochures, informed consent, safety updates, IND/NDA submission documents, study submission package, plans and manuals of clinical trial projects and study related contracts.
- Develop local study materials and contribute to SOPs that adhere to global clinical trial standards.
- Bachelor’s degree is required (preferably in healthcare, pharmacology, nursing, biomedical or life sciences area. Advanced degree is preferred. Certification in specialized area a plus.
- Minimum 6 years experience in Clinical Operations with strong background in pharmaceutical, CRO and/or biotech industry.
- Global registration trial experiences will be a plus.
- Experience in hematology or oncology area is preferred.
- A leadership presence as the primary operational contact for team assigned to the studies.
- Experience managing cross-functional study management teams.
- Thorough understanding of FDA, GCP and ICH guidelines.
- Strong organizational/project management/interpersonal skills.
- Development and implementing metrics and clinical study patient recruitment strategies and exhibit strong presentation skills.
- Ability and willingness to travel (up to 25%)
Benefits of working with our team:
PharmaEssentia USA strives every day to be people-centric. We focus on improving the lives of not just patients, but of our employees too. As part of a valued member of PharmaEssentia USA, you will enjoy the following benefits:
- Comprehensive medical coverage: 80% employer paid
- Dental and vision coverage: 100% employer paid
- Generous paid time-off
- 401(k) retirement plan with competitive company match
- Medical Flexible Spending Account
- Up to $100 monthly cell phone reimbursement
- Employee Assistance Program
- Work/Life balance with core working hours from 10am – 3pm
- Weekly team meals
- Free on-site gym
- Free on-site yoga classes offered Spring-Fall
- Team outings
- Free parking at office in Burlington, MA
- Potential for better commute
- Supportive work environment
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
Only direct applicants need apply. No recrutiers please. Please apply via LinkedIn.