COMPANY: Collegium Pharmaceutical, Inc. (www.collegiumpharma.com)
JOB TITLE: Director of Clinical Operations
LOCATION: Cumberland, RI

The Company:
Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through formulation based product improvements protected by intellectual property (IP). Collegium is focused on building a portfolio of pain products that incorporate its patent protected DETERx™ formulation platform that provides for sustained release and tamper resistance. The Company through its subsidiary, Onset Therapeutics (www.onsettx.com) develops and commercializes products for skin and skin related disorders using its novel DELEVO™ Foam Technology. For more information, visit the Company’s website at www.collegiumpharma.com.

Responsibilities:
The Director of Clinical Operations is responsible for the preparation of preclinical and clinical development plans and protocols for products in the areas of pain and skin related disorders. This will involve collaborating with the R&D teams and contributing to activities such as target selection, product delivery profile, with goal of IND filing. The other responsibilities include planning and managing phase I –IV clinical trials. He/she will oversee all aspects of day to day operations for clinical development programs and outsourced studies; which include; managing medical writing, and drug safety, monitoring, and managing of clinical program coordinators, research associates and clinical data managers. He/she will negotiate contracts with vendors, develop and maintain budgets and be responsible for timely collection of high quality data from all sites.

Key Functions:

1. Provide leadership and direction for all clinical activities, including establish scientific, FDA and industry practice methodologies for design and implementation of clinical protocols, data collection systems and final reports.
2. Establish or adopt clinical, regulatory, and safety SOPs
3. Timely report and resolve all AEs and SAEs.
4. Develop clinical relationships with physicians, vendors, business contacts, external experts and/or relevant scientific organizations.
5. Interact with expert internal and external advisors, consultants, and regulatory groups; and participate/lead in clinical development strategy.
6. Contribute to the preparation of a variety of corporate and regulatory clinical documents.
7. Develop information for presentations to senior management, clinical collaborators and/or other groups.
8. Execution of company clinical development strategies and plans.
9. Coordination of Clinical Operations activities across all sites overseeing site initiation and management, clinical data collection and review, and study closeout procedures.
10. Plan all clinical operation activities for US IND, NDA and other international regulatory filings. Familiar with clinical Common Technical Format.
11. Oversee Budgetary and Financial Management responsibilities for Clinical Operations including budget forecast and cost estimates for clinical studies.
12. Forecast and manage clinical operations product supplies and timelines.
13. Lead contract negotiations and maintain ongoing relationships with vendors

Requirements:

1. Clinical Degree, MD, RN, PharmD or other equivalent degree.
2. A minimum of 5 years biotech, pharmaceutical, clinical trial organizations clinical trial experience in preparing, implementing managing clinical trials performed to US and other International GCP standards intended for submission to regulatory authorities. Regulatory experience in other regions is helpful.
3. Extensive direct experience in clinical trial design, execution and analyzing clinical data and results.
4. Very responsive in dealing with AEs and SAEs.
5. Strong leadership, management and people skills.
6. Extensive knowledge of US GCP, ICH guidelines and industry-wide clinical development processes and procedures.
7. Strong communication and presentations skills, with experience interacting with investigators and clinical trials staff, and the ability to represent the Company s clinical development operations.
8. Flexible, professional, team oriented and capable of motivating personnel, effecting change and working across departments.
9. Strong Project Management experience, i.e. resourcing, adheres to budget, managing to timelines and deadliness.

Compensation:
An attractive compensation package commensurate with qualifications and experience will be offered to the successful candidate.

Report to: President

Submit Information:
Submit cover letter and resume via e-mail to busdev@collegiumpharma.com or mail to Attn: Human Resources, Collegium Pharmaceutical, 400 Highland Corporate Drive, Cumberland, RI 02864.