Senior Clinical Development Leader
We are seeking a Senior-level clinical development leader to oversee the design and implementation of multiple clinical development programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, their customers, markets, business operations, and emerging issues. The person in this role will oversee project-related education of investigators, study site personnel, and study staff.
How you will spend your day:
- Leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy.
- Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
- Oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
- Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
- Participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
- Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
- Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Represent Constellation at key external meetings.
- Responsible for understanding the regulatory requirements related to the clinical studies and drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Key Things about you:
- Medical Doctor (M.D) degree with relevant therapeutic specialty. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- Minimum 10 years of clinical trial experience in the pharmaceutical industry
- Ability to run a complex clinical research program independently
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
- Must possess excellent oral and written English communication skills.
- Ability to exercise judgment and address complex problems and create solutions for one or more projects.
We are an Equal Opportunity Employer, a participant in E-Verify and offer great benefits including all the usual important stuff, paid parking or commuter pass, flexibility, generous time off, favorite snacks and a Cambridge Athletic Club in the building.
If you are interested in joining Constellation’s team please submit your resume to the following address: email@example.com
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at firstname.lastname@example.org
Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.