The Director, Clinical Development serves as the medical/clinical sciences lead and is responsible for co-developing the CDP in accordance with the project strategy.
Primary role for this position involves managing and successful execute late phase clinical trials in orphan indication. This position is responsible for keeping all project/program team members apprised of activities and decisions that may impact clinical deliverables. A high level of communication and leadership skills are required. This position is the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, regulatory authorities, medical affairs, Key Opinion Leaders, Advisory Boards, etc.
1. Provides multidisciplinary, scientific/medical leadership across multifunctional project teams.
2. Provides scientific, technological and medical knowledge and expertise for the clinical research aspects of the project and provides clinical and therapeutic expertise, with a working knowledge of regulatory affairs, to the development of the project strategy and the clinical development plan (CDP).
3. Serves as the clinical research representative for products in development at strategic meetings or advisory boards.
4. Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc).
5. Develops, executes and regularly maintains the project CDP and other relevant clinical documents that are consistent with the project goals.
6. Consults with internal/external stakeholders and internal/external key opinion leaders to validate the scientific and medical components of the CDP.
7. Works closely with the clinical operations group, and provides strategic direction to support timely and on budget development and execution of the clinical development program.
8. Serves as the scientific or medical representative with investigators and regulatory authorities.
9. Interacts with the Medical Science Liaison personnel.
10. Develops and gains approval by Senior Management for study protocol outlines and study plans created by the clinical project team.
11. Participates and supports the clinical study team in site selection/evaluation including site training and to provide sufficient medical/scientific knowledge for educating the study team and investigators and explain the scientific, epidemiologic background and justification of a study/project.
12. Plays a primary role in identifying key opinion leader(s)/principle investigators for the program to ensure adequacy of the program’s scientific basis and obtain endorsement on the assumptions related to medical needs and clinical utility represented in the project development strategy.
13. Participates as lead clinical representative on cross-functional project team.
14. Supports clinical study and operational teams:
a. Developing the study synopsis, complete study protocol, case report forms, statistical plans, blinded independent evaluation protocols, etc.
b. Reviewing the clinical study documents such as protocols, CRFs, SAPs, etc.
c. Conducting blinded independent evaluation
d. Problem solving
e. Providing clarification on protocol requirements and entry decisions
f. Developing team competencies
g. Providing input to operational team members who will execute the studies
h. Adhering to the timelines
i. Delivering high quality medical science resulting in high quality efficacy and safety data
j. Bringing relevant matters, including monthly reports to the attention of relevant stakeholders as required
15. Provides medical and scientific interpretation of efficacy and safety data; and to seek advice of other experts as required.
16. Accountable for the clinical study reports including expert reports, integrated summaries, and other regulatory documents, etc.
17. Plays a key role in the interactions with regulatory authorities (e.g., FDA, EMEA meetings). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities.
18. Provides input for a project publication plan, liaises with commercial and work on launch activities when required.
19. Helps to identify additional opportunities within the broad R&D portfolio; propose indications and study design approaches for establishing proof of concept and help to identify and evaluate opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio.
20. Reviews abstracts and manuscripts created by internal or external sources.
U.S. licensed Medical Doctor (MD or equivalent qualification) preferred; PharmD or PhD also acceptable.
The ideal candidate must have at least 5 years experience in clinical research (preferred Phase 2-3trials) gained working for a pharmaceutical, biotechnology or CRO company.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop relationships and generate collaborations.
• Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record.
• Solid medical/scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents.
• Working knowledge of statistics, data analysis and data interpretation.
• Experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB’s, and GCP/ICH are necessary.
• Excellent written and oral communication skills and a command of the English language are a must.
• Organizational and cross functional collaboration skills.
• Approximately 10 to 25% domestic and international travel is required.
• Proficient in Microsoft Office (i.e., Word, Excel, SharePoint and PowerPoint).