Manager/Senior Manager Clinical Sciences

Company Overview:

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation.  Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

Job Overview: 

The Manager/Senior Manager, Clinical Sciences is responsible for scientific input to R&D and clinical strategies to ensure translation of the development plan into operational deliverables. The individual is responsible for and contributes to the scientific content of clinical program documents including but not limited to Study Protocols, Investigator’s Brochures, Clinical Study Reports, Regulatory Submission Documents, Scientific Material and Publications. This role would primarily support the NMIBC or LMs program.

 Essential Duties and Responsibilities include the following (Other duties may be assigned):

• Responsible for day-to-day clinical science input/management for assigned clinical studies.
• Ability to work cross functionally with Clinical Operations, Data Management, CROs, Medical Writing, Statisticians, Medical Director-Clinical Development and Regulatory Affairs.
• Liaise with Data Management and Biostats to ensure key data elements are captured consistently and correctly.
• Provides scientific input into clinical data reviews, development of clinical presentations and integration of analyses into clinical documents.
• Responsible for clinical review and input during study start up and study conduct in collaboration with clinical sub-team.
• Performs review of medical literature and scientific material including publications, conference abstracts and posters, research databases and provides relevant knowledge related to disease state and compounds.
• Provide scientific input for the development of clinical study designs, analysis and interpretation of data.
• Responsible for scientific content (authorship/review) and development of clinical documents including study synopses, protocols, protocol amendments, ICFs, IBs, CSRs, DSURs.
• Contribute to the development of scientific documents including conference abstracts, manuscripts and other scientific material in collaboration with internal and external stakeholders.
• Contribute to the development of clinical/scientific components of regulatory dossiers and meeting material (eg, INDs, BLAs/MAAs, Type B/C FDA meetings).
• Provides scientific support/input for crossfunctional activities including Program Management, Publications, Medical Affairs, Commercial Development, and Business Development.

Education:

• Advanced Degree in a scientific or healthcare related discipline required; doctorate degree (Ph.D.) preferred.

Supervisory Responsibilities:  None

Qualifications:

 Overall experience with 5-7+ years in a highly scientific environment; the Senior Manager will have at least 3-5+ years of experience in the pharma/biotech industry, and the Manager will have at least 1-3+ years of experience in the pharma/biotech industry.

• Experience in developing clinical protocols, clinical study conduct and/or review of clinical data
• Familiarity with drug development process and ICH/GCP.
• Familiarity with statistical methodology and interpretation of clinical data.
• 3-5 years of experience in medical/regulatory writing and submission of regulatory documents is preferred.
• Experience in oncology or rare disease is preferred.

Other Skills and Abilities: