Director of Clinical Development — Interim, Specialty Pharma

The mandate

The clinical development director began extended medical leave while a pivotal study was behind enrolment and accumulating protocol deviations. Regional teams can administer sites, but nobody currently holds authority to make benefit-risk, country or recovery choices.

The cover must commence inside four weeks and lasts ten months through last-patient-last-visit and database lock. The incumbent is expected to return, and a four-week re-entry period is built into the fixed term.

The handover threshold is full enrolment within the revised statistical window, all significant deviations adjudicated, database lock achieved on the approved date, and a submission-ready clinical narrative accepted by the chief medical officer.

The interim may close underperforming sites, open pre-qualified replacements, approve protocol clarifications and move up to ₹80 lakh within the study budget. Protocol amendments affecting endpoints, safety reporting positions and total spend above threshold require governance approval; the director cannot change the compound's indication strategy.

Preclinical studies, manufacturing comparability and commercial launch preparation remain with their existing functions. This mandate is confined to credible execution and scientific oversight of the pivotal programme.

Why this seat is open

Medical leave removed the programme's senior clinical decision-maker at a sensitive point. Waiting for the incumbent would place database lock and the submission sequence at risk. The company has chosen experienced fixed-term cover while preserving the substantive role for the returning executive.

What you will own

• Reforecast enrolment by country and site using screened, randomised, dropout and competing-study evidence.
• Decide which sites close, recover or receive additional recruitment resources within approved country strategy.
• Chair medical data review and adjudicate protocol-deviation significance with safety, statistics and operations leaders.
• Approve clarification letters, investigator communication and recovery actions that do not alter protocol endpoints.
• Protect the database-lock path through a dated query, coding, reconciliation and document-readiness control plan.
• Draft the clinical interpretation narrative and expose uncertainties before submission governance review.
• Return the programme to the incumbent with an indexed decision record and four weeks of joint medical review.

Candidate qualifications

• Medical degree with eighteen-plus years in industry clinical development, including leadership of pivotal interventional trials.
• Direct accountability for enrolment recovery, medical monitoring and database lock in a regulated multi-country programme.
• Skilled interpretation of efficacy, safety and protocol-deviation data without trespassing on independent statistical judgment.
• Experience closing or replacing research sites based on evidence while maintaining investigator and patient continuity.
• Thorough knowledge of ICH-GCP, Indian clinical-trial requirements, safety escalation and inspection-ready trial documentation.
• Capable of covering a returning leader's seat respectfully and leaving decisions transparent rather than building dependency.

Non-negotiables

• Available within four weeks for Delhi NCR and Asia-Pacific study travel.
• No investigator, advisory or equity conflict involving competing compounds in the indication.
• Accepts that the mandate ends with database lock and the incumbent's planned return.
• Maintains current medical credentials appropriate to clinical-development oversight.

1. 49 words maximum. When can you start, and which existing trial obligations require conflict disclosure?
2. 49 words maximum. What enrolment deficit did you recover before a pivotal database-lock deadline?
3. 49 words maximum. Describe one site you closed and the evidence that outweighed continuity concerns.